Life Science Compliance Update

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32 posts from March 2011

March 15, 2011

FDA Guidance for Industry on Medication Guides

Medguide 2 

The Food and Drug Administration (FDA) recently published Guidance for Industry on Medication Guides, entitled “Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).” The guidance is intended to address two topics pertaining to Medication Guides for drug and biological products:


-       When FDA intends to exercise enforcement discretion regarding when a Medication Guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient.

-       When a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).




In 1998, FDA issued final regulations establishing requirements for the distribution of patient labeling for certain prescription drug and biological products used primarily on an outpatient basis without direct supervision by a health professional (63 FR 66378, December 1, 1998).


These regulations, codified in 21 CFR part 208, apply to certain drug and biological products that FDA determines pose a serious and significant public health concern requiring the distribution of FDA-approved patient medication information that is necessary to patients’ safe and effective use of the drug products (a Medication Guide).


Medication Guides apply primarily to human prescription drug products used on an outpatient basis without direct supervision by a health professional and are applicable to both new and refill prescriptions. FDA is authorized to require a Medication Guide if FDA determines one or more of the following circumstances exist:


·         The drug product is one for which patient labeling could help prevent serious adverse effects.

·         The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients’ decision to use, or continue to use, the product.

·         The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.


Part 208 specifies the content and format of Medication Guides and manufacturer requirements to provide Medication Guides for distribution. Manufacturers of drug products for which a Medication Guide is required must:


·         Obtain FDA approval of the Medication Guide before the Medication Guide is distributed, and

·         Ensure that Medication Guides are provided in sufficient numbers, or provide the means to produce Medication Guides in sufficient numbers, to distributors, packers, and authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product.


Part 208 also specifies the requirements for distribution of Medication Guides:


·         Distributors and packers who receive the Medication Guides, or the means to produce Medication Guides, must provide the Medication Guides or the means to provide them to authorized dispensers.

·         Each authorized dispenser of a prescription drug product for which a Medication Guide is required must provide the Medication Guide directly to each patient or each patient’s agent when the product is dispensed, unless an exemption applies.


FDAAA Requirements for Medication Guides as Part of REMS


The Food and Drug Administration Amendments Act of 2007 (FDAAA) created new section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which authorizes FDA to require a risk evaluation and mitigation strategy (REMS) when necessary to ensure that the benefits of a drug outweigh the risks. Under section 505-1(e), FDA may require that a REMS for a drug include a Medication Guide for distribution to each patient when the drug is dispensed.


Under part 208, Medication Guides may be safety-related, addressing serious risk(s) (relative to benefits) of which patients should be made aware, and/or efficacy-related, when patient adherence to directions for use is crucial to the drug’s effectiveness. Since the enactment of FDAAA, FDA has considered any new Medication Guide (or safety-related changes to an existing Medication Guide) to be part of a REMS. However, the Agency has the authority to determine, based on the risks of a drug and public health concern, whether a Medication Guide should be required as part of a REMS, and may decide the Medication Guide should be required as labeling but not part of a REMS if FDA determines that a REMS is not necessary to ensure the benefits of the drug outweigh its risks.


Consequently, questions have arisen concerning FDA’s policy on whether the Medication Guide must be distributed every time the drug is dispensed because part 208 states that the regulations are intended to apply primarily in the outpatient setting.


FDA can require the development of — or safety-related changes to — a Medication Guide and require these changes to be implemented quickly, whether or not a Medication Guide is part of a REMS. Medication Guides are part of labeling and are subject to the safety labeling change provisions of FDAAA. Under these provisions, FDA can require the development of a Medication Guide (or safety-related changes to an existing Medication Guide) based on new safety information of which FDA becomes aware after approval of the product.




One goal of the guidance is to articulate the circumstances under which FDA intends to exercise enforcement discretion regarding the requirement to dispense Medication Guides in certain settings, such as when it is dispensed to a healthcare professional for administration to a patient in an inpatient setting.


Questions have arisen concerning the requirements for distribution of a Medication Guide when a drug is not dispensed directly to a patient for self-administration or to the patient’s caregiver, but rather is dispensed or distributed to a healthcare professional who then administers the drug to the patient. For example, in an inpatient setting such as a hospital or nursing home, drugs are dispensed by the hospital pharmacy and then administered by hospital staff to patients. Similarly, in an outpatient setting such as a clinic or infusion center, drugs are dispensed or distributed to a healthcare professional who then administers the drug to the patient, sometimes without the involvement of a dispensing pharmacy or pharmacist. In some cases, these drugs are administered to a patient several times a day or several times a week.


Circumstances under which FDA intends to exercise enforcement discretion regarding Medication Guide distribution


A Medication Guide need not be distributed (i.e., FDA intends to exercise enforcement discretion concerning distribution of a Medication Guide to a patient) when a drug is dispensed under the following circumstances:


-       When the drug is dispensed to a healthcare professional for administration to a patient in an inpatient setting (with exceptions)

-       When the drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting, such as in a clinic or dialysis or infusion center (with exceptions)  


In these settings, the drug will be dispensed to a patient by a healthcare professional who should provide the patient instructions on appropriate use of the drug, including what potential side effects may occur or followup that may be required as appropriate, and answer any questions the patient may have.


Circumstances under which FDA will not exercise enforcement discretion and a Medication Guide must be dispensed to a patient in inpatient and outpatient settings


A Medication Guide must be distributed (i.e., FDA does not intend to exercise enforcement discretion) in the following situations:


-       When the patient or the patient’s agent requests a Medication Guide.

-       When a drug is dispensed in an outpatient setting (e.g., retail pharmacy, hospital ambulatory care pharmacy) and the product will then be used by the patient without direct supervision by a healthcare professional.

-       The first time a drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting, such as in a clinic or dialysis or infusion center.

-       The first time a drug is dispensed in an outpatient setting of any kind, after a Medication Guide is materially changed. FDA plans to specify in the letter approving a revised Medication Guide when a change is considered to be a material change and applicants will be directed to notify healthcare professionals that a material change was made.


FDA stated that a Medication Guide should be dispensed in outpatient settings, even when the drug is dispensed to a healthcare professional for administration to the patient, the first time the drug is dispensed, and if the Medication Guide is materially changed because it will assist the healthcare professional in communicating important information about the drug to the patient.


Medication Guides as Part of REMS


While all Medication Guides must meet the standard and requirements in part 208, not every newly required Medication Guide will be an element of a REMS. In most cases, FDA expects to include a Medication Guide as part of a REMS only when the REMS includes elements to assure safe use. However, FDA will include a Medication Guide in a REMS that does not include elements to ensure safe use if FDA determines that having the Medication Guide without a REMS will not be sufficient to ensure that the benefits of the drug outweigh the risks.


Applicants with a REMS that includes a Medication Guide, a communication plan, and a timetable for assessment also may submit a prior approval supplement that proposes a REMS modification to remove the Medication Guide from the REMS, if they do not believe that a Medication Guide that is a part of the REMS is necessary to ensure that the benefits of the drug outweigh the risks. FDA will review any such supplements and determine whether the Medication Guide is necessary to ensure that the benefits of the drug outweigh the risks of the drug, as a tool of a REMS under section 505-1. The proposed REMS modification must be accompanied by a REMS assessment (described in the guidance).


Even if the Medication Guide is removed from the REMS or the REMS is eliminated, the Medication Guide will continue to be part of the approved labeling in accordance with part 208, unless the FDA approves a supplement removing the Medication Guide from the approved labeling.

March 11, 2011

University Policy: Duke and UNC Consider Revising Policies on Collaboration with Commercial Interests

Duke_Blue_Devils Northcarolinatarheels-300x240 

The Duke University School of Medicine presently has a policy regarding relationships with industry that requires faculty to disclose the existence of outside partnerships but does not prohibit employees from working for outside medical companies. According to Dr. Ross McKinney, director of the Trent Center for Bioethics, Humanities and History of Medicine, the Duke University School of Medicine Conflict of Interest Policy establishes an obligation for faculty and staff to avoid ethical, legal, financial, and other conflicts of interest to ensure their activities do not interfere with their University obligations.

The policy also states that those who may feel they have a conflict of interest must file a disclosure form with a dean or his designate. In addition, Duke requires all medical faculty and staff to report each February any outside contracts. While Duke is concerned that a relationship with industry could lead to bias, their current policy still reflects the important need to maintain the role of industry-physician collaboration in improving medical training and patient outcomes.

Additionally, the policy clearly reflects the fact that “For some modern doctors and researchers, work for outside pharmaceutical companies supplements traditional pay,” since physicians in academia generally make significantly less than private practice and industry.

However, policies at Duke, along with other medical school policies across the country, could change soon as academic medical centers increasingly begin to use payment databases created by ProPublica. Two reasons for the change in policies are apparent.

First, the American Medical Student Association, which grades universities on their conflict of interest policies, gave both Duke and UNC a "B" on their most recent scorecards. Duke earned a "D" last year, then was upgraded to a "C." Second, according to an article from The Chronicle, Duke University’s newspaper, “North Carolina alone accounts for 3.41 percent of all industry payouts nationwide at $10,385,554.” Based on these developments, Duke and UNC are feeling pressure to change their policies, even though there is no evidence to show that physician-industry relationships harm patients.

McKinney said that a revision of Duke’s conflict of interest policy is still under way. The policy will be university-wide, applying to both physicians and academic faculty members like English professors. He said it’s a “long, slow process” that will also consolidate separate policies for research, purchasing, clinical care and education. 

Changes in Policy

In light of the publication of such payments and the changing trend of academic medical centers stance on physician-industry relationships, the Herald Sun reported that “revisions of conflict of interest policies are coming along at Duke Medical Center and UNC Hospitals to make the relationships between doctors and drug companies more transparent.”

At UNC, the Herald Sun reported that a new conflict of interest policy was implemented on January 1, 2011, after 18 months in the works, that pulls previous policies together under one blanket policy. “The new policy is in line with health care reform laws that will require all drug companies to report their payments to physicians beginning in 2013.”

Meals and Gifts

Five major categories constitute a financial relationship and must be reported: income in any form, ownership interest, in-kind compensation, royalties and gifts. Under the new policy, all gifts are prohibited, even items of minimal value like pens and notepads.

The new policy also prohibits covered personnel from accepting meals or other hospitality from Vendors, but with two exceptions. First, where meals are served as part of general professional conferences or meetings supported in whole or in part by Vendor(s), it is acceptable for registered attendees to participate in meals included in the event registration. On the other hand, Covered Personnel must pay for their own meals if attending an educational meeting  organized by a Vendor as an invitation-only event and held at a restaurant or resort. 

Second, Covered Personnel engaged off-site in approved consulting activities may accept meals provided in conjunction with such activities. Such meals are considered part of reasonable compensation for consulting activities.

Under no circumstances may Covered Personnel accept complimentary tickets to sporting or other events from a Vendor

Speaking, Consulting

Employees also must disclose to supervisors the amount they expect to receive from consulting work. The new policy also bans ghostwriting (as defined in the policy), but it does allow prior review of manuscripts and presentations by Vendor representatives.

The new UNC policy prohibits faculty from participating in speakers’ bureaus “whose principal aim is the support of a product, service or device manufactured or marketed by the entity directly or indirectly providing such compensation. However, permissible consulting may include participating as a speaker at an event where:

  • The content of the lecture does not recommend specific drugs, devices orother  commercial products or services; and
  • The content of the lecture is based on best available evidence; and
  • The event sponsor does not provide honoraria or gifts to the attendees; and 
  • In the estimation of the supervisor authorized to approve the consulting activity, any honorarium and travel expenses paid for the speaker’s participation  are reasonable.


Compensation, travel reimbursement and hospitality associated with external  professional activities for pay must be reasonable and consistent with the educational or scientific purpose of the event. 


Drug or device or other product samples given to Covered Personnel by industry representatives must be deposited and distributed according to the UNC Policy. Where such samples are given for research or other non-clinical purposes, acknowledgement of the donation must be made by the University through appropriate channels. No service, right or license may be given to the donor in conjunction with the gift of the sample except through a written contract signed by an authorized official.


The policy only states that “all educational events sponsored by the School of Medicine or UNCHCS must comply with ACCME Standards for Commercial Support.”

Conflict of Interest?

Doctors who work for companies provide services ranging from speaking engagements, educational  to consulting. Yet for some, these relationships raise concerns about conflicts of interest and whether academic faculty and staff can ensure their primary duties—treating patients and conducting research—come first.

Wesley Byerly, associate dean for research services at Duke however noted that not all conflicts of interest “are inherently bad, provided that doctors are transparent about their existence.” For example, “faculty who discover ground-breaking research or invent a new drug have a stake in the success of their own work. Similarly, a doctor can work for an outside company without letting it compromise patient care.”

He noted that conflicts of interest issues “arise when there is a lack of “transparency” by physicians or researchers, he said. In fact, he said that “Conflict of interest is not bad or wrong,” but rather that the university is “concerned about when there is a conflict that is not known or that can’t be evaluated or managed in a way to ensure that it doesn’t appear to or actually influence their study [or practice].”

Byerly further noted that Duke essentially has “100 percent reporting, which is almost unheard of,” and that “faculty and staff are very good at letting us know what their relationships [with outside institutions] are.”

Academia-Industry Collaboration

One of the physicians discussed in The Chronicle who was identified from the ProPublica database was Dr. David Rizzieri, a doctor and associate professor for the medical school’s Cellular Therapy division. He noted in an e-mail that he discloses all of his outside partnerships with the University, limits the amount of activity and time away from Duke’s campus and avoids enrolling patients in or serving as a principal investigator for a study of a drug owned by companies he works for.

Dr. Rizzieri further wrote that “he gives educational presentations and promotional lectures relevant to his field of study at the request of a physician or nursing group, and he conducts research studies for treating leukemia or lymphomas with new agents in part developed by the companies themselves.”

He asserted in his e-mail that his “relationships with various companies have allowed him to reach out and meet with practitioners and health care providers all over our region.” Dr. Rizzieri further maintained that he “benefits by gaining a better understanding of what their experiences are in treating these diseases and using these agents in community cancer centers.” By working with industry and educating his colleagues, Dr. Rizzieri recognized that they “are able to compare and contrast their experiences and see how treatment at a large medical center with a selected patient population may or may not reflect what happens in the community.”


Ultimately, as Dr. Rizzieri asserted, “patients are not negatively affected,” by physician-industry relationships and that “properly managed relationships with pharmaceutical companies can benefit patients.” As more and more academic medical centers begin to change their policies, it is important that these changes are made in a transparent manner. Academic medical centers that create such changes as a way to appease media and government critics, without considering the negative consequences such policies can have on patients and hindering the training and education of physicians will only hurt medicine and stifle innovation.

March 10, 2011

University Policies Make Them Easier or Harder?

University of Colorado 
Earlier this year, we noted that the University of Colorado Medical Campus, National Jewish and Denver Health, were considering “overhauling their conflict of interest policies.” Consequently, the Faculty Senate at the University of Colorado Medical Campus is set to take up this issue very soon. 

In a recent commentary in the Denver Post, Thomas P. Stossel, MD, American Cancer Society Professor of Medicine and a director at Harvard Medical School, noted that the impact of this policy “is likely to influence profoundly the future of medical discovery and patient care.” 

Dr. Stossel explained how the Faculty Senate is revisiting its so-called "conflict of interest policy" governing its faculty's relationships with industry, a primary engine of medical innovation and medical education. He noted that the outcome will determine whether to make such relationships easier or harder. 

First, Dr. Stossel commended CU for “its world-class faculty who provides outstanding patient care, cutting-edge medical innovation and solid education for students and community physicians.” He explained how his wife obtained dental and public health degrees from CU and served on its faculty, and his brother-in-law received life-saving treatment at its hospital; and Dean, Richard Krugman, was also his college classmate.” 

Accordingly, he noted his confidence “that CU will take advantage of a unique opportunity to rethink its restrictions on external collaborations, a concept opposed to the very basis of CU's excellence.” 

Dr. Stossel noted that since he and Dean Krugman “entered the medical profession over 45 years ago, patient care has improved immensely - almost entirely because of tools and treatments now available to physicians and derived from collaborations between physicians and private industry.” Unfortunately, Dr. Stossel recognized that “a movement spearheaded by a small group of well-connected activists, and abetted by media outlets seeking splashy headlines and by demagogue politicians, coined the pejorative term "conflict of interest" and is dedicated to eliminating or harshly regulating such collaboration.” 

He explained how “this movement alleges that physician-industry relationships are corrupt - that they supposedly increase medical costs, bias medical education and alarm the public.” However, these “allegations invert reality.” Dr. Stossel recognized that “medicines account for less than 15 percent of overall health care costs and 70 percent of all prescriptions are for inexpensive generic products. Therefore physicians' prescribing practices have little impact on overall health care expenditures.” 

More importantly, Dr. Stossel acknowledged that, “these powerfully useful tools derived from physician-industry relationships do not benefit patients unless physicians prescribe them. Education, irrespective of who pays for it, prolongs and improves quality of life and speculation that "conflict of interest" adversely impacts medical care has no basis in fact.

Unfortunately, Dr. Stossel notes, “physicians' practical preoccupations with caring for their patients, working in their labs and educating colleagues diverted them from focusing on the falsity of the movement's allegations.” As a result, “many medical centers rushed into formulating garbled "conflict of interest" policies that pay lip service to the value of collaboration while limiting or eliminating physicians' freedom of speech, freedom of association and freedom of reward for excellence.” 

As Dr. Stossel correctly recognized, “these policies divert precious resources from innovation and education to regulation and compliance. Worse, they are having unintended consequences including documented decreases in medical device development collaborations, with a corresponding decrease in FDA approvals, and reduced commercial support for medical education. Furthermore, the regulations mean fewer community physicians receive education from medical school faculties.” 

Consequently, Dr. Stossel notes that CU’s current conflict of interest policy “is better than many - including that of his own medical school,” because “it permits common-sense exceptions to unnecessary prohibitions of valuable activities, such as faculty educating other physicians concerning specific company products.” However, “recent media opportunism, exploited this flexibility to demonize perfectly legitimate industry-derived income of CU faculty members. In response, the CU Faculty Senate is poised to revisit its industry relationship policy.” 

Ultimately, Dr. Stossel recognized that “CU now has a unique opportunity to approach industry relationships with the same rigor it applies to the science of medical innovation and education. It can break the imitative defensive reactions attempting to appease politicians and the media (neither of which promote medical innovation) that have caused so many medical institutions to create policies that are harmful to their mission - to advance patient care - and promote rather than strangle its faculty's relationships with industry.” He asserted that “CU owes it to its grateful patients to take such leadership” and the he knows “CU will do the right thing.”

March 09, 2011

Pharmaceutical Coupons A Health Choice

One of the biggest challenges facing health care reform is how to control health care costs while maintaining a high quality of care that is both effective and efficient. While much of the debate that led up to the passage of the Affordable Care Act (ACA) discussed controlling health care costs, the $1 trillion price tag on the legislation has left many Americans wondering how this complex and complicated legislation will actually reduce health care costs.

Many of the provisions in the ACA do not specifically address how the legislation will control health care costs. For example, there are a number of provisions, which assert that the use of health information technology (HIT) and electronic medical records (EMRs) will reduce medical errors and save money. However, no data to date has proven these claims, and numerous issues such as privacy, compatibility, training, and funding present significant obstacles to achieving this goal. As a result, it may be years before Americans realize the costs benefits, if any, from HIT and EMRs.

Other provisions that address costs include reducing fraud, waste and abuse in Medicare and Medicaid. But these provisions do not “control costs,” they merely act as oversight and provide additional funding to give the government the resources they need to effectively monitor these federal programs.

Accordingly, supporters of the ACA who believe it will help control health care costs often point to the provision that helped closed the doughnut hole, which refers to the gap in coverage that leaves Medicare beneficiaries on the hook for the cost of prescription drugs when the cost of their prescription drugs passes $2,700 in a year. The success of this provision was achieved through an $80 billion agreement between the Obama administration and pharmaceutical companies.

Eventually, this agreement found its way into the ACA by fixing the gap and providing that seniors receive a 50% discount on the brand name drugs they purchase while they are in the "doughnut hole." The provision became effective January 1, 2011.

Since the provision addressed high prices for prescription drugs for Medicare beneficiaries, many policymakers and media sources utilized the image of elderly patients having to pay out of pocket expenses to assert that health care costs continue to rise because prescription drug prices are too high.

In fact, the New York Times continued this myth in a recent story by suggesting that pharmaceutical companies are leading to an overall increase in health care costs by using co-payment cards and coupons that “are just marketing gimmicks.” Co-payment coupons and cards are distributed by drug company sales representatives to doctors, and are also often available directly to patients over the Internet. Patients present them at the drugstore when paying for their prescriptions

Drug companies cannot offer co-payment assistance for patients in federal programs like Medicare because such offers are considered an inducement to use a drug and in violation of anti-kickback laws. Some companies have responded by contributing to, or even helping to set up, charitable foundations that can provide co-payment assistance legally.

The Food and Drug Administration, meanwhile, is studying the effect of the discounts on consumer perceptions, concerned that the coupons will make consumers believe that a drug is safer or better than it really is.


Pharmaceutical companies frequently use rebates, coupons, and co-payment cards to assist patients with paying for prescriptions. As the Times points out, “With drug prices rising and many people out of work, pharmaceutical companies are increasingly helping patients with their co-payments.” In fact, according to IMS Health, an information company that tracks the pharmaceutical industry, “the use of such co-payment cards and coupons and other types of discounts has more than tripled since mid-2006.”

Health insurers and some consumer groups say that in many cases, the coupons “circumvent the system of higher co-pays on costlier drugs that insurers use to encourage consumers to use less expensive products.” However, drug companies say the plans help some patients afford medicines that they otherwise could not. For example, Pfizer last month introduced a new card that can reduce the co-pay on its blockbuster drug Lipitor to $4 a month, a savings of up to $50. That brings the out-of-pocket cost in line with what consumers might pay at Wal-Mart for a generic version of a competing cholesterol-lowering drug.

Critics however believe that this process insulates the consumer from the cost of the prescription, and “In essence, it drives up the total cost of providing the prescription benefit.” They further assert that any “shift to brand-name drugs can have a big impact on health care costs.” But what about very expensive drugs or treatments which there are no generic for?

In some cases, as the Times explains, “co-payments can be up to 20 percent of the price of the drug,” especially for chronic conditions, which can cost up to $800 a month. Accordingly, as Robert M. Myers, President of Jazz Pharmaceuticals told analysts in November, “The coupon program helps patients get low monthly out-of-pocket costs.” Drug companies further defend the coupons, saying they are “helpful to consumers and allow patients and doctors to make decisions based on medical reasons, not costs, because in many cases, such as with Lipitor, the rival drugs are not exact generics.”

Joshua J. Ofman, vice president for reimbursement and payment policy at Amgen told the Times that the co-pay assistance is aimed at ensuring that differences in co-payments between the two drugs “aren’t driving medical decisions.” Companies also say that lower co-payments help patients stay on their medicines. The Times also acknowledged “Studies that have shown that patients are more likely to quit taking their drugs when the co-pay is high.”

If patients are more likely to quit taking their drugs when the co-pay is high, why would we want to prevent companies from providing coupons to reduce that cost? Chances are, if patients quit taking their medicine in these cases, the costs associated with their discontinuation of care, including hospitalization and the potential for developing symptoms that are more serious will far exceed any increased cost for the use of a brand name drug.


The main problem with the Times article is that it fails to recognize or even mention that prescription medicine costs are not what is driving increased spending for health services or insurance. As we previously noted, prescription medicines account for only 10 cents of every dollar spent on health care, and while many people consider spending on prescription drugs in the U.S. to be increasing or very expensive, money spent on drugs is considerably less than spending on hospital care or physician services. In addition, chronic disease, which accounts for $3 out of every $4 spent on healthcare, is what threatens the U.S. health care system, not the cost of medicines.

Moreover, the Times article also neglects to mention that although 81% of drug sales in 2009 were for brands for which a generic existed (up from 61% of the time 2003), 92% of the time patients get the generic. In fact, many states require that a pharmacy give a generic if it is available and a doctor has not expressly stated a need for the brand name drug.

As one commentator carefully pointed out, the pharmaceutical companies are not necessarily the ones to blame for high prescription costs when “America’s health insurance companies increased their profits by 56 percent in 2009, a year that saw 2.7 million people lose their private coverage.” In fact, the nation’s five largest for-profit insurers closed 2009 with a combined profit of $12.2 billion, according to a report by the advocacy group Health Care for American Now (HCAN).

In that case, why should the pharmaceutical companies be taking the blame when they are the ones trying to reduce costs for patients, and the insurance companies are merely trying to squeeze out every time from their policyholders?


In the end, “Helping patients with co-pays is a good marketing program at a time when the abandonment rate of prescriptions is at an all time high.” As we noted above, when patients do not take their medications, “there is a strong chance that their health conditions can worsen and cause higher costs to an already strained health care system.”

Patients have the choice to ask for generic or a branded product and by reducing the costs of co-pay, companies are merely offering patients a choice. Given that generics still make up a huge percentage of total number of prescriptions, to “suggest that drug companies are driving up health costs for insurers is a one-sided argument that negates the patients right to choose.”

March 08, 2011

Maryland “Gift Ban”: HB 818 Manufacturers of Prescribed Products - Payments to Health Care Professionals – Committee Hearing

Last week, the Maryland House of Delegates Government Operations Subcommittee held a hearing on HB 818, known as the Manufacturers of Prescribed Products – Payments to Health Care Professionals – Prohibition. As introduced, the purpose of the legislation is to prohibit a manufacturer of prescribed products from offering or giving a gift to a health care professional. We previously provided a summary and analysis of the bill.

Consequently, at the hearing, the overwhelming majority of members from the public spoke against the legislation. Below is a list of those who testified on HB 818, including a brief summary of their testimony. To view the hearing on HB 818 click here. Testimony begins at 5:18:22, that is right 5 hours and 18 minutes into the hearing.


Maryland Delegate Nicholaus Kipke (R-Anne Arundel County) 

Mr. Kipke, the sponsor and author of the bill, spoke in favor of the legislation. He called for the creation of a strong firewall because prescription drug use in Maryland has increased over the past 10 years. Of course, he failed to realize that healthcare and patient outcomes, life expectancy, and treatments of other disease have significantly improved for Maryland patients over that time as well.

His testimony focused on the incident at St. Joseph’s hospital, which was his clear motivation for the legislation. He talked about thought leaders and consultants who go out and talk to doctors over meals. He chided industry codes for them being voluntary.

Consequently, Mr. Kipke was asked what the difference between politicians getting payments from industry in the form of political contributions to candidates and doctors receiving “gifts” or payments for services. He struggled to find how there was an ethical difference in these kind of payments. Mentioned that there was rules by members of legislature. He also struggled to answer whether HB 818 will slow down access of physicians to information from companies. He did however admit, that HB 818 will most likely slow down access. 

Delora Sanchez, Nicki McCann, and Julie Gottlieb – Johns Hopkins

John Hopkins offered its support of HB 818 but with specified amendments, which they provided to the committee. The panel talked said JHU’s 2009 policy on interactions with industry was similar to HB 818, but emphasized that HB 818 must ensure appropriate interactions between industry-physician, including education.

The amendments offered focused on the fact that accredited continuing medical education (CME) has adequate oversight, and that there is a need to modify the provision in HB 818 that calls for more than one presenter. The panel also recognized that industry support of CME is welcomed and necessary and not an issue because accredited providers adhere to strict standards of commercial support, which prohibit marketing and promoting products.

Moreover, JHU asserted its concerns that HB 818 could be interpreted so broadly to eliminate HCPs taking part in these activities to recommend treatments. This is problematic because doctors need to be able to educate physicians that a given disease can be treated with a specific class of medicine that is supported by evidence, and practice. JHU also emphasized the need to allow training for devices, and noted that a written agreement should be with the institution who purchases the devices, not the HCP.

Wendy Kronmiller – Assistant Secretary Regulatory Affairs/Maryland Division of Regulatory Affairs, Department of Health and Mental Hygiene

MDMH supported the bill because of concerns about overutilization and overpayments of drugs and patient harm. They clarified that they did not want to thwart medical progress by enacting HB 818 and put Maryland behind other states in conferences and medical events. The testimony clarified that the Sunshine Act in the Affordable Care Act is only a disclosure registry, rather than a ban, and they were not sure whether this would be good enough for Maryland, since consumers may not use it. 

Howard Fienberg - Marketing Research Associates (FWA)

Marketing Research Associates supported HB 818 with an amendment that the legislation excludes survey research because there needs to be incentives to encourage people to participate in bona fide surveys. He noted that marketing research, doesn’t influence participants or get them to do something.

Dan Bellingham – HDMA Health Distribution Management Association

Noted that there are 12 companies that operate in MD, and that the association opposes the bill because of its inclusion of wholesalers. He clarified that wholesalers only take the product from producer to hospital, pharmacy, office, etc. Wholesalers don’t push one product over another. No marketing on products, only services, in wholesaling. He recognized that in Minnesota, Massachusetts, Vermont, and the Sunshine Act, wholesalers were specifically excluded.


Jay Schwartz - MedChi (opposed/amendments)

MedChi was opposed to the bill, and emphasized that the bill was poorly written and sloppy. MedChi noted that the legislation would negatively impact accredited CME by preventing meals. Mr. Schwartz noted the hypocrisy in this portion since government meetings sponsored by pharmaceutical companies could have such meals. In addition, he emphasized the positive value pharmaceutical companies provides to hundreds of thousands of medical programs in Maryland that doctors participate in. He gave the example of an ophthalmology program, supported by industry, that examined delegates and their staff in the capitol just a few weeks before the hearing. In the end, he emphasized that there should not be a ban on giving education and industry support to groups, because these are good programs. He asked the committee to look at MedChi’s guidelines on gifts to physicians, that were approved in 1992. He acknowledged that these physician-industry relations are extremely complicated, and a more nuanced approach similar to the 8 page policy from AMA is necessary.

Michael Altus

Mr. Altus, a medical writer, supported the bill because through his experience working for pharma, his concerns and experience about ghostwriting caused him to worry about gifts. He emphasized the fact that companies have their own policies about employees giving and receiving gifts, and that there is no such thing as a “free lunch.”

Marta Harding – AdvaMed

On behalf of AdvaMed, Ms. Harding noted that 25 members of AdvaMed are based in Maryland, and three attended and testified at the hearing. She noted how these companies have thousands of employees in the state. While AdvaMed understands and shares the concerns of bill, Ms. Harding noted that AdvaMed has taken aggressive steps to address to address these issues, including a strict and aggressive code of conduct. Accordingly, she asserted that HB 818 will have negative unintended consequences that will stifle appropriate interactions with doctors and industry, which promote innovation and patient safety.

Chris White – General Counsel for AdvaMed

Mr. White discussed his leadership in helping create the AdvaMed Code of Ethics. He noted how devices demand close physician-industry interaction and that most companies are small, with 50 employees or less, but that many of these bring many breakthrough technologies. He discussed one example, an orthopedic hip, which is highly personalized and requires over 300 instruments. He noted that these devices are supported by physician intervention and collaboration, and that devices serve as an extension of a surgeons hands. As a result, he acknowledged that a highly interactive relationship between physicians and industry is what fuels ongoing advances in medical technology and that training physicians on to use these devices is critical for patients safety

He also noted that HB 818 is negative because it would prohibit demonstration devices, which allow doctors to show patients what treatment/device they would get. Finally, he also emphasized that the Sunshine Act and anti-kickback statutes are sufficient to address the concerns of HB 818.

Kevin Tibido – Vapotherm

Speaking on behalf of a small company, Mr. Tibido’s testimony focused on the administrative burden of complying with HB 818. He too recognized that the AdvaMed Code and federal regulations are adequate. He discussed how his company makes a respiratory device that replaces more complex/expensive technologies. Staff of his company go into offices and hospital and meet with physicians, nurses, and therapists, to make sure they broadly know how their technology works, how to save patients from more evasive procedures, and how to operate the devices safely. Finally, he recognized that meals provided for these training sessions are not unethical because often, HCPs have no time other than lunch to be educated.

Richard Hewitt – VP of CSI Medical

Also from a small medical company in its early stage with 20 employees, Mr. Hewitt discussed his company’s approved device that helps treat cancer. The device is FDA approve and has been used in over 6,000 treatments, in over 80 AMCs, and has been written about in 15 articles in 9 peer reviewed journals. Now that the product has taken off, his company wants to grow and add employees and tax base in Maryland, but he noted that the key thing to growth is robust physician interaction during testing, development. Without high frequency interaction with nurses andphysicians, he noted that his company would fail. And he clarified that these interactions were luxurious or glamorous, but rather coffee and bad food purchased not to induce, but to stay alive.

He recognized that devices help fill unmet needs of patients and that doctors need much more training for medical devices. He noted that a problem with HB 818 is that it would prohibit a company from having a researcher in surgery because it would only be one educator from one company. Without this training, someone would be hurt or die. Accordingly, he stated that Maryland needs to remain competitive to attract genius and capital, and should be making business easier not harder.

Michael Radford – WL Gore and Associates

Mr. Radford echoed concerns about HB 818, and noted that his company’s 23 plants and 2300 employees would be impacted because of the costs and administrative burdens to implement the legislation. He emphasized the importance of device companies interacting with doctors for initial development, training and feedback.

Renee Wensky – CEO Tech Council of Maryland

Representing the biotechnology trade association, Ms. Wensky opposed HB 818 because it is unnecessary, duplicative, and will harm Maryland as a leader in innovation/medicine. She noted how BIO already has a wide array of regulations and agencies overseeing its ethical concrerns, and that HB 818 will just add more regulation and infrastructure cost with little return. It would also put small companies at a competitive disadvantage, and will restrict their ability to research. She also noted that HB 818 would make it difficult for Maryland to attract and retain companies.

John Murphy – BIO

BIO oppose the bill and echoed Ms. Wensky’s comments, noting that small companies will be impacted most directly because compliance costs are difficult to overcome for small companies, and such legislation is unnecessary because these companies already deal with federal regulations.

Tom Sullivan – Rockpointe, Inc. 6:23:40

I talked about the impact HB 818 will have on CME in Maryland. I discussed a wounded warrior program that my company produced, where physicians were educated to treat pain from soldiers, that would be prohibited because it was supported by industry.

I emphasized that HB 818 will jeopardizes patient care by having a chilling effect on the necessary exchange of new treatments, including FDA mandated education. I also noted that the bill would imperil medical education/training and that hospitals and institutions will discontinue CME programs to avoid violating the law. This will kill the market for CME programs, especially when meals would not be allowed. I echoed others in noting that HB 818 is also duplicative because of existing federal laws, such as AMA, ACCME, HHS OIG.

A family practitioners, who is the director of treatment for methadone clinic echoed my comments, and noted the importance of CME events to gain intelligence and improve care for patients. He noted how CME programs supported by industry are crucial because it allows him to interact with colleagues, ask questions, ask speakers how to treat problem patients, and permits 1 on 1 dialogues with speakers and peers.

Lee Gresser, MD, Medical Director Methadone Clinic

Dr. Gresser former President of the Maryland Association of Family Physicians noted that the intent may be good but his concern is the bills negitive effect on continuing medical education.   He was surprised at the Hopkins support given their collaboration on events such as PriMed.    He loves the interaction with colleagues and with speakers on important issues provided in dinner meetings.  Brought up that physicians have discernment and discussed the high integrity of the pharma and device companies.  There are 27,000 physicians in Maryland and only one ran into trouble, wants proactive not re-active legislation.

Patty Camorrata

Ms. Camorrata has 12 years working in CME, and noted how CME providers collaborate with universities, societies, and other groups to look at disease state. Then, they conduct literature research, talk to leaders in areas, and create education plans based on research. She noted how CME improves performance and providers are very involved in metrics and measuring learning to identify gaps in education. She noted that learning requires repetitive activities and that if it does not happen, learning goes back to base level. She concluded by noting that if Maryland gives up local/regional meetings, we will give up repetitive opportunity for learning, which will directly impact patients in Maryland.

Marjorie Powell –PhRMA

Ms. Powell noted how 20 companies in Maryland are working on rare diseases that affect 200,000 people or less. She noted that these 20 companies in Maryland are doing research or have an application at FDA to market a treatment for one or more rare diseases. Consequently, under HB 818, if they wanted to hire professor from JHU to talk to researchers about the research that that academic physician did on a rare disease to help provide background on disease to their researchers, they could not because it would be a “gift.”

If company got FDA approval to market for a rare disease, they could not pay the physician at JHU who ran the clinical trial, to talk to physicians around Maryland about how to use that drug to treat that rare disease, or even how to identify the symptoms of the rare disease within their patients because this would also be a “gift.”

Ms. Powell noted the critical need to tell HCPs about drugs once they are approved, how to use that product, what appropriate indications are, and when you can and cannot use it. She recognized that that FDA often requires training and education for drugs that have benefits/risks for patients.

She also emphasized that PhRMA believes there shouldn’t be gifts to encourage prescriptions, and how federal laws and anti-kickback laws already address this issue.

Gary Reno – Aisi Inc.

As a biopharmaceutical company, with 50 employees in Baltimore, Mr. Reno noted how his company makes products for treatments for brain tumors. He asserted that the federal laws are adequate enough not to need HB 818, and that if passed, the bill would have negative consequences for patients in Maryland.

March 07, 2011

HHS-OIG: CMS-FDA Drug Registration and Listing Systems In Need of Update

Pharmceutials on Table 
The Centers for Medicare and Medicaid (CMS) is America’s largest healthcare payer, covering the costs for hospital and physician services, treatments, drugs and devices for approximately 45 million Americans. In fact, Medicaid payments for prescription drugs totaled approximately $24 billion in 2008.

To qualify for Federal payment under Medicaid, the Food and Drug Administration (FDA) generally must first approve the safety and effectiveness of the drug, with certain exceptions. As a result, it is necessary for FDA to collect and maintain drug product and approval information so that CMS will only cover or make payments for FDA approved products.

To keep track of drug products and approval, FDA created the Drug Registration and Listing System (DRLS). As part of the DRLS, FDA maintains a publicly accessible database of currently listed drugs called the National Drug Code (NDC) Directory. FDA has additional databases containing approval information for biological products such as vaccines and blood (among others), used in the prevention, treatment, or cure of a disease or condition. Another is Drugs@FDA, which is a publicly available FDA database that provides each drug’s approval history, including approved labels, and indicates whether it was approved under a new drug application or an abbreviated new drug application; it does not list any of this information by the NDC.

The NDC Directory contains the name, the NDC (i.e., a numeric drug identifier), and the approved application number for each listed drug. The DRLS also includes nonpublic files of pending and discontinued NDCs.

However, according to a recent report from the Department of Health and Humans Services (HHS) Office of the Inspector General (OIG), the FDA has acknowledged that the databases in DRLS may be inaccurate and incomplete. Specifically, the report revealed that while 62% of drugs paid for by Medicaid in 2008 had an approved application number in the NDC Directory—totaling $17.8 billion—the remaining 38% either did not have an approved application number listed or were not in the NDC Directory at all.

As a result, the report highlighted the fact that the NDC Directory cannot reliably be used to verify the approval and listing status of drugs paid for under Medicaid.


In 2008, the Office of Inspector General (OIG) received a congressional request to examine the FDA approval status of drugs paid for by Medicaid. To address this request, OIG used 2008 Medicaid utilization data for prescription drugs, approval and listing data from FDA, and a targeted manual review. OIG found that:

-       12% (3,158) of NDCs paid for by Medicaid in 2008 were listed in the NDC Directory but did not include an approved application number (i.e., the approved application number was “other,” was blank, or could not be determined).

-       More than three-quarters of these NDCs (2,426) had an approved application number listed as “other” in the NDC Directory and were not included in the other FDA databases.

-       Medicaid payments for drugs associated with these 2,426 NDCs totaled $803 million in 2008.

-       Each of the remaining 732 NDCs had (1) an application number of “other” but was included in 1 of FDA’s other databases, (2) an approval status that was blank, or (3) an approval status that could not be determined.

In addition, 26% (7,040) of the 27,143 NDCs associated with drugs paid for by Medicaid in 2008 were not listed in the NDC Directory. More than half (3,893) of these NDCs were listed in the pending, discontinued, or biological files. The remaining 3,147 NDCs were not listed in any of these files. Therefore, OIG concluded that FDA would be unable to determine the approval status based on the NDCs alone. Medicaid payments for these 3,147 NDCs in 2008 totaled $1.1 billion.


After explaining its findings, OIG noted that previous reports also found problems with the accuracy and completeness of the NDC Directory and recommended changes to improve the database. Accordingly, FDA recommended that to improve the completeness and accuracy of the NDC Directory, FDA should:

-       Conduct frequent reviews of its NDC Directory to ensure its completeness and accuracy; and

-       Work with the CMS and Congress to seek a legislative or regulatory change that compels manufacturers to list all approved products with FDA before the products become eligible for Medicaid payment.

OIG noted that “by making payment under Medicaid contingent upon listing, manufacturers would have an increased incentive to ensure that FDA had the most complete and timely information on the products in the NDC Directory.”


In response to OIG’s report, “FDA generally agreed with OIG’s recommendation to improve the completeness and accuracy of the NDC Directory.” FDA stated that:

-       It recognizes that data quality has suffered in the past

-       Agrees that the accuracy and completeness of data in the NDC Directory are imperfect;

-       It remains committed to robust quality improvements; and

-       It has already begun implementing several initiatives for evaluating and enhancing the quality of drug-listing data.

Additionally, FDA has agreed that it should work with CMS to examine changes that could further strengthen CMS’s ability to ensure that drugs are listed with FDA prior to reimbursement.

However, FDA did point out that OIG’s manual review was limited because it examined only a small sample of NDCs. As a result, FDA asserted that most “inaccuracies did not result in improper Medicaid payments, and that the NDC Directory is now more complete and accurate.”


The inability of FDA to keep track of drugs approved is problematic for a number of reasons and reflects the weaknesses and obstacles the agency is currently facing. Millions of Americans depend on the drugs that FDA approves and which CMS covers. If patients are denied coverage for drugs or treatments because FDA has not included an approved product in its database, Americans could go without treatment or suffer in pain needlessly.

Both CMS and FDA should work with industry to help find solutions to this problem given that industry is also equally aware of what products are FDDA approved and covered by CMS. This kind of collaboration would ensure that the government is paying for approved drugs and that Americans are not hindered in receiving adequate care.

March 04, 2011

ABMS MOC CME White Paper: SACME and CMSS Responses

In response to the American Board of Medical Specialties (ABMS) White paper on CME for Maintenance of Certification (MOC), the Society for Academic Continuing Medical Education (SACME) and the Council of Medical Specialty Societies recently made comments to the Joint Working Group on MOC and CME.


SACME, raised several concerns in their comments regarding content of the draft white paper. One concern they raised is that the document states that diplomates involved in relevant educational activities must be able to demonstrate learning or improved outcomes. SACME is concerned that in practice this will have an unintended consequence and translate into a requirement for improved outcomes only, and this  could  undermine learning. SACME believes the next version of this proposed white  paper needs to clarify the meaning of  "learning  and/or  improvement  outcomes" to  avoid this  problem.

SACME also raised serious concerns about the funding framework described in the document. SACME asserted that the ABMS artificially made the present state of funding one end of the spectrum and thus forces the focus and discussion towards the opposite end, which as described in the document is a state of no acceptable funding. However, SACME recognized that “the current valid framework should be one in which one end of the commercial support spectrum is full funding without any controls and the far end is no commercial funding.”

Under such a valid framework, SACME noted that “the present system is seen as an attempt to find an appropriate mid-point. The validity of such a framework has been supported in studies on bias and support. This is simply lost in the framework described in the document.” Furthermore, SACME recognized that “choosing to utilize such a framework might unfortunately give the impression to some that the ABMS might be biased on this important topic, an impression that SACME suggests ABMS avoid by shifting to the suggested framework.” Ultimately, SACME asserted that the consequences of such a position would be to significantly, and unnecessarily hamper the conduct of high quality CME.

Although SACME wholeheartedly agreed that public trust in the health care system and their provider is an important issue, “focusing on any possibility of an event is a false idol.” They asserted that “science and healthcare can and must focus on probabilities not possibilities as anything and everything is possible.” Accordingly, SACME noted that “defining public trust in such a manner appears to be an extremist position and sets the bar at a height where any and all systems must fall.” In addition, “it is contrary to the very evidence that exists which shows patients, at a reasonable percentage, just want to be aware of who has paid their physician, how much and for what purpose. Patients are not interested in physicians not being paid for what they do, they are interested in enhanced transparency without stifling innovation.”

SACME also pointed out that “even the courts established a little over a year ago that the standard for a judge is the probability of bias not the possibility of bias, in part for the very reason that one can only address probabilities.”

Lastly, SACME noted that the white paper does not define team-based education, and recommended the document elaborate on the benefits of multidisciplinary and inter-professional approaches to education. SACME also recommended that a firewall be re-erected and that the ABMS, and its component boards, return to a state in which their role is to create standards but not barriers to high-quality, evidence-based cost-effective education.


CMSS raised concerns about the ABMS white paper as well. They noted that the document blurred the boundaries between the “separate roles for entities assessing physicians (certifying boards) and educating physicians (specialty societies and others),” which risks placing certifying boards in positions of conflict of interest that the US system has avoided since the inception of certifying boards (Ophthalmology in 1916 and Otolaryngology in 1924) and ABMS (in 1933).

As such, CMSS does not support language in the document that does not clearly separate the roles of certifying boards as standard setters and assessors of physician knowledge and practice, with the roles of specialty societies and others as educators and facilitators of practice improvement among physicians.

Instead, CMSS recommended clarifying the language so that the language clearly states what is meant for the reader to understand. CMSS further recommends that this finding clearly articulate the separate roles for certifying boards as standard setters and assessors of physician knowledge and performance, and for specialty societies and others as educators and facilitators of physician performance improvement in practice.

With respect to funding, CMSS asserted that “the overwhelming evidence from articles published in the peer reviewed literature calls attention to the documented influence on prescribing practices and practice behaviors of direct financial relationships between industry and physicians.”

However, CMSS recognized that the same influence “is not documented in the peer reviewed literature for commercial support of CME in the 20 years since the adoption and implementation, and 7 years since the revision of the ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME (ACCME SCS).”

Accordingly, CMSS recognized that “public perception is shaped more by public media than by peer reviewed literature and that the media have been unclear as to the differences between direct financial relationships of industry with physicians, compared with industry support of CME providers under the ACCME SCS.” As a result, they note that the profession must clear up the understanding and communication of these relationships.

CMSS noted that unfortunately, “the current draft of the MOC CME White Paper fails to draw the appropriate distinctions between the consequences, in perception and in reality, of direct financial relationships of industry with physicians, and of industry support of CME providers under the ACCME‐SCS.” In so doing, CMSS asserts that the “draft does a disservice to the profession, and to the public whose trust the profession seeks to serve.”

Accordingly, CMSS recommended that the draft read:

“The profession of medicine, stewarded by ABMS, by specialty societies and by others, is continually challenged to serve responsibly in the public’s interest and trust. As such, it is important for ABMS through setting standards for MOC CME to reflect both the reality and perception of the consequences of relationships between industry and physicians, as well as between industry and CME providers. Both sets of relationships have come under public scrutiny, and both deserve consideration.

 Articles published in the peer reviewed literature reveal that direct financial relationships between physicians and industry influence physician prescribing practices and practice behaviors. In contrast, strict adherence to the ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME results in continuing education for physicians which is independent and unbiased, regardless of the source of financial support.

It is therefore incumbent on the profession, through certifying boards setting standards for MOC CME, and through specialty societies and others providing independent and unbiased programming and activities for physicians participating in MOC CME, to incorporate these realities into the design MOC CME.”

In addition, CMSS also took issue with the language used in the white paper that the ABMS and the MOC Committee should “assist” the Member Boards. They noted that it is unclear what is meant by “developing approaches” and it is unclear what is intended in the recommendation to “assist member boards.” If “developing approaches” means setting standards, then CMSS would support this concept, as standard setting is an appropriate professional role for both ABMS and for its certifying boards. If this is the case, CMSS recommended clarifying this language to state its intent.

If “assist member boards” means that ABMS will develop programs, activities, registries for physician data or other elements of implementing knowledge or performance assessment coupled as part of a performance improvement cycle with educational intervention and/or practice improvement, then CMSS has significant concerns.

CMSS acknowledged that “these roles are separate from and beyond standard setting or assessment, which are the purview of ABMS and its certifying boards, and fall within the purview of specialty societies and others. Again, they recommended clarification of this language to reflect the separate roles of certifying boards and specialty societies would be key to our support of this document.

Accordingly, CMSS asserted that “ABMS should limit its activities to standard setting and assessment of physician knowledge and performance, and should not enter into activities which develop programming, including registries, for intervening in the education of physicians or facilitating the improvement of the performance of physicians in practice, which are the roles of specialty societies and others.”

CMSS recommended that the document read, “ABMS should assist member boards in setting standards for and assessing physician knowledge and performance that incorporate the following characteristics:”

Lastly, CMSS recognized that the document is unclear as to what is meant by establishing a “general framework” to reduce or eliminate the influence of commercial entities, and asked for clarification. In “eliminating or reducing, to the extent possible, influence exerted by commercial entities,”CMSS assumed that this refers to managing in some way relationships between physicians and industry. Consequently, they said “it is not clear how certifying boards would accomplish that task, nor is it clear that it is the purview of certifying boards to do so.”

However, CMSS asserted that should “this phrase be directed toward commercial support of CME used for MOC, then it ignores the current function of the ACCME‐SCS, which serve to eliminate influence exerted by commercial entities.” Since strict adherence to the ACCME‐SCS eliminates influence,  CMSS asserted that “there is no further need to recommend that it be reduced to the extent possible.” As a result, they recommended the document to say:

“ABMS should support the profession’s self regulation of direct financial relationships with industry and commercial support of CME rather than proposing to establish separate policy and procedure in these areas. ABMS should express its support of the strong language and strict requirements of the professional self‐regulatory bodies and codes that govern relationships between industry, physicians and physician organizations.

Should ABMS wish to express concerns or recommendations for modifications to professional self‐regulation of relationships between physicians and industry, such communications should be directed to the entities whose Codes govern such relationships, such as the AMA CEJA Ethical Opinions on Gifts to Physicians from Industry, the CMSS Code for Interactions with Companies, and the ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME.”


So far the responses have been by and large harmonious with two simple messages:

A)    Engage the ACCME in developing standards for CME for MOC

B)    For commercial support for the ABMS to focus on quality and see that providers strictly follow ACCME Standards of Commercial Support.

All the ABMS member board requirements need to weigh the demand for greater access to health care under the Affordable Care Act which more of physician’s services are performed by less regulated allied health professionals with increasing standards.  At the specialty boards standards are winning but at the state boards access is holding the day.

March 03, 2011

Alliance for CME Social Media Best Practice Guidelines

The Alliance for CME (Alliance) recently decided to establish a formal presence in a variety of social media channels as part of its expanding communication strategy.  The Best-Practice Guidelines provide a resource for CME providers to follow when considering and using social media in continuing medical education (CME).

The Alliance noted that providers should comply with the organization’s policies and bylaws and keep its core values of embracing innovation, collaboration, respect and integrity in mind at all times. This includes knowing and following the Alliance’s Code of Ethical Conduct.

One obvious ruled to follow was that CME providers using social media should not post any material that is obscene, defamatory, profane, libelous, threatening, harassing, abusive, hateful, or embarrassing to another person or entity.

As such, the Alliance stated that it reserves the right to moderate, discontinue/delete a disruptive post, insist upon adherence to this policy’s guidelines, determine what constitutes disruptive behavior, and unsubscribe/block repeat offenders.

The Alliance also noted that messages posted on external sites represent the views and opinions of the individual posting the information and do not reflect Alliance policies or positions unless clearly labeled as such. 

In addition, the best-practices asked CME providers using social media to respect copyright, fair use and financial disclosure laws and not to provide confidential or other proprietary information. The best-practices also tells social media users to ask permission to publish or report on conversations that are meant to be private or internal to any organization.

The best-practices expressly forbid on Alliance sites the rebroadcast of petitions, chain letters, “get-rich-quick” schemes, political rants, hoaxes, and other spam messages. Additionally, the use of sites to solicit business or distribute a commercial message is strictly prohibited. 

The Alliance recommended that discussions on the sites should stimulate conversation and present a variety of perspectives, not to create contention.  Avoid challenging or attacking others. Try to add value. If it provides worthwhile information and perspective; if it helps you, your coworkers, and/or our members to do their jobs, solve problems, and improve knowledge or skills; if it builds a sense of community; or if it advocates for the CME/CE/CPD professional or the profession, then it is adding value.

AMA CPPD Report : Change to Physician Recognition Award, Physician Re-Entry

This month, the American Medical Association (AMA), through its Council on Medical Education and Division of Continuing Physician Professional Development (CPPD), discussed updates and revisions to enhance the AMA PRA credit system.

In their monthly newsletter, CPPD Report, the AMA discussed new changes and requirements under the AMA Physician’s Recognition Award (PRA) and the AMA PRA credit system.


In 2009, the CPPD staff began a series of meetings with the CME stakeholders. From April 2009 through August 2009, there were 22 meetings held with more than 160 representatives from 58 organizations. These included representatives from Accreditors, ACCME, state medical societies, the American Board of Medical Specialties, pharmaceutical companies, and a number of professional societies and organizations such as the American Osteopathic Association and the American Academy of Family Physicians.

The information gathered in these meetings was summarized with the results and recommendations presented to the AMA Council on Medical Education in June 2010. The council discussed proposed changes and adopted several revisions to the AMA PRA credit requirements to be effective for all activities certified for AMA PRA Category 1 Credit™ presented or released on or after July 1, 2011. The council also approved the 2010 revision of the document “The Physician’s Recognition Award and credit system.

Changes to AMA PRA System

The newly revised booklet also provides a definition of Certified CME:

  • Nonpromotional learning activities certified for credit prior to the activity by an organization authorized by the credit system owner, or
  • Nonpromotional learning activities for which the credit system owner directly awards credit

Enduring materials

 Enduring materials must include an assessment of the learner that measures achievement of the educational purpose and/or objective(s) of the activity with an established minimum performance level that is communicated to the physician prior to participating in the activity. The intent of this requirement is that AMA PRA Category 1 Credit™ is only awarded to a physician who demonstrates that he or she met the objectives of the activity.

The AMA has not specified the type of assessment, questions or performance level that an accredited CME provider must use. The CME provider may use different assessment types based on the enduring material (e.g., multiple-choice questions, case-based questions, short-answer, essays), as well as different levels of performance for different  types of enduring materials. Whatever assessment is used, however, it must be graded to determine that the physician achieved at least the minimum level that was established by the CME provider. The CME provider must ensure that the minimum level of achievement for which AMA PRA credit can be awarded is communicated to  prospective participants prior to their participation in the activity.

Journal-based CME activities

Journal-based CME activities must also include an assessment of the learner that measures achievement of the educational purpose and/or objective(s) of the activity with an established minimum performance level that is communicated to the physician prior to participating in the activity. Again, the intent of this requirement is that AMA PRA Category 1 Credit™ is only awarded to a physician who can demonstrate that he or she met the objectives of the activity. Journal based CME activities have the same requirements for these assessments and the awarding of credit as enduring materials.

Manuscript review activities

As written the current requirements for manuscript review activities could be interpreted to mean that a physician may receive credit for submitting an unacceptable review but would not be allowed to continue to participate or receive credit for subsequent reviews. The new requirement clarifies that a physician who participates in manuscript review activities may only be awarded AMA PRA Category 1 Credit™ if the editor of the journal considers the review to be acceptable. This requirement is designed to ensure that a physician only receives credit for demonstrating successful completion of the CME activity.

Performance improvement CME (PI CME) activities

There is now clarification that physicians must begin a PI CME activity with Stage A in order to assess their practice based on the chosen performance measures and establish a baseline prior to implementing changes in their practice. This enables a physician to determine the reasons for not reaching the optimal performance and to identify interventions that are needed to improve this performance.

AMA credit designation statement

The AMA credit designation statement has been modified in two areas. First, it is now required that the first sentence of the credit designation statement indicate that the activity was developed to meet the specific requirements of one of the seven AMA approved learning formats. This change lets potential learners know what type of activity they will be participating in and indicates to credentialing organizations, once the documentation of completion is submitted and received, the type of activity learners have successfully completed.

The second sentence was modified by moving the word “only” to modify “credit” rather than “claim” to make the sentence grammatically correct. The modified AMA credit designation required for all activities certified for AMA PRA credit is:

 The [name of accredited CME provider] designates this [learning format] for a maximum of [number of credits] AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Within the United States, the AMA only authorizes organizations accredited by the ACCME or by a state medical society recognized by the ACCME (referred to as “accredited CME providers”) to designate and award AMA PRA Category 1 Credit™ to physicians. Each certified activity must comply with the 10 AMA core requirements as well as the format-specific requirements for one of the seven AMA approved learning formats. Only activities developed as one of these seven learning formats may be certified for AMA PRA Category 1 Credit™. These approved learning formats include:

-       Live activity

-       Enduring material

-       Journal-based CME activity

-       Test item writing activity

-       Manuscript review activity

-       PI CME activity

-       Internet point-of-care activity

It is not acceptable to use any other language to refer to the learning formats in the credit designation statement since only these seven formats have been approved for credit by the AMA.

Presentations at the National Task Force on CME Provider/Industry Collaboration

More than 425 participants gathered for the 21st Annual Conference of the Nation Task Force on CME Provider/Industry Collaboration, held October 13–15 in Baltimore.

The keynote address “Principled partnerships: Practical or pipe dream?” was delivered by Darrell G. Kirch, MD, president and CEO of the Association of American Medical Colleges. The theme for this year’s conference, which was staffed by the AMA, was “Moving forward in an age of uncertainty: Creating innovative, practical educational solutions.” Providers who were unable to attend the meeting, can now view conference presentations online. 

CPPD webinar information

CPPD staff will be hosting webinars in the coming months to help CME providers learn more about these changes and how they will impact the planning and implementation of activities certified for AMA PRA Category 1 Credit™.  Each webinar will include a Q&A period with the presenters. CPPD promises to answer all questions that are received by participants during the presentation—even if time runs out during the webinar. Webinars on the 2010 revisions to the AMA PRA credit system will be held on:

-       February 24, noon–1:30 p.m. CT

-       June 29, noon–1:30 p.m. CT

Physician re-entry to clinical practice: Overcoming regulatory challenges

In an effort to address regulatory barriers to physician re-entry, the AMA, in collaboration with the Federation of State Medical Boards (FSMB) and the American Academy of Pediatrics (AAP), held a conference titled Physician Re-entry to Clinical Practice: Overcoming Regulatory Challenges in May 2010.

The conference resulted in the formulation of 16 recommendations that, when taken together, are designed to ease a range of barriers to physician re-entry. These recommendations were organized with the following goals in mind:

  • Ensure that there is a transparent and feasible process for physicians to return to practice
  • Develop policies that assure the quality of re-entry programs and their graduates
  • Create an evidence-based approach that can be used in re-entry program development
  • Develop means to ensure that re-entry is financially feasible
  • Ensure that all stakeholders participate in planning for a physician re-entry system

The AMA said it will continue collaborating with relevant organizations to further the development of a coordinated approach to physician re-entry, including hosting another conference with stakeholders if necessary. The FSMB’s Special Committee on Re-entry to Practice is preparing a report with recommendations on the issue that is expected to be completed in 2011.

The issue of physician re-entry into the work force is growing in importance within medical boards especially with physicians who may take off two or more years for a child or have left practice and decided to come back all have to take CME courses to be relicensed. 

As stakeholders work to develop re-entry policies, processes and educational approaches, it is important for the CME community to address the role it will play in the development of a coordinated approach. 

Supreme Court Rules in Favor of Protecting Vaccine Makers from State Lawsuits

The United States Supreme Court reached a decision recently, concluding that federal law protects vaccine makers from product-liability lawsuits that are filed in state courts and seek damages for injuries or death attributed to a vaccine.

In the 57-page opinion written by Justice Antonin Scalia, the Supreme Court explained that the National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine’s side effects.

The Court’s 6-2 decision reasoned that “a vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element. The language of the [NCVIA] thus suggests the design is not subject to question in a tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design.

This conclusion is supported by the fact that, although products-liability law establishes three grounds for liability—defective manufacture, inadequate directions or warnings, and defective design—the Act mentions only manufacture and warnings. It thus seems that the Act’s failure to mention design-defect liability is “by deliberate choice, not inadvertence.”

The opinion further explained that “design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process.” As a result, the Court concluded that this “lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability.”

Justice Scalia’s opinion further reflected the belief that “[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.” 

The family that brought the lawsuit against Wyeth (now Pfizer) argued that their daughter suffered seizures as an infant after her third dose of a diphtheria-tetanus-pertussis, or DTP vaccine in 1992. They also stated that she had serious developmental delay caused by the DTP vaccine, and that a safer alternative had been available but not made available. Eventually, the vaccine was taken off the market in 1998 and replaced.

Pfizer argued that a Supreme Court ruling in favor of the family would have sparked countless lawsuits, including some claiming links to autism, and threatened the supply of childhood vaccines.

One of the rationales for the Supreme Court’s decision came from the fact that “vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries. In exchange, they avoid costly tort litigation and the occasional disproportionate jury verdict.”

According to an article from Reuters, the vaccine court has awarded more than $1.8 billion for vaccine injury claims in nearly 2,500 cases since 1989.

After the ruling, American Academy of Pediatrics (AAP) president O. Marion Burton applauded the Supreme Court’s decision in a statement. He noted that the “decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country.”

The AAP, along with 21 other physician and public health organizations submitted amicus brief's supporting Wyeth, and noted that a ruling against the manufacturer could “precipitate the same crisis that Congress sought to avert in passing the Vaccine Act: ‘the very real possibility of vaccine shortages, and, in turn increasing numbers of unimmunized children, and, perhaps, a resurgence of preventable diseases.”

Ultimately, this decision could have significant impacts on similar vaccine suits associated with diseases such as autism.


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