Life Science Compliance Update

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28 posts from May 2010

May 28, 2010

Research America Study: American’s Confident in FDA and Biomedical Research

Before taking your next insulin shot or beta blocker, did you ever wonder how the medication your taking went from the labs into your hands?  A recent survey conducted by Research America An Alliance for Discoveries in Health, asked this question and many others during an online sample of 1,000 American adults in February 2010. 

The survey, conducted by the Research Enterprise Poll was demographically representative of adult U.S. residents, and was funded by Eli Lilly and Company, which commissioned Charlton Research Company to conduct the poll. Among some of the interesting findings included in the survey, the results showed that:

-  72% of Americans are very confident or confident in the FDA’s safety review system, although it was down from 74 percent in 2007;


- 41% say the FDA approval process takes too long;  

- Only 5 percent were not confident in FDA’s safety, down from 11 percent in 2007;


- 76% say clinical research is of great value, and the same number say they are likely to participate in a clinical study, but only 6% say their doctor has ever suggested that they do so;  

- 93% say it is important-and 69% say very important-for the U.S. to be a global leader in medical, health and scientific research;


- When asked to name the government agency that funds most of the taxpayer-supported medical research in the U.S., nearly one in five mistakenly named the FDA; fewer than 10% correctly named the NIH; and      

- Nearly three-quarters of Americans are confident in our system for reviewing the effectiveness and safety of new medicines and medical devices;

Another interesting finding was that Americans were split almost evenly regarding their opinion about the pace of FDA approval. Specifically, 52% felt that FDA should move faster, while 48% said FDA should act more slowly. In addition, 92% of respondents felt that it was somewhat important or very important that Congress fund university-based experts to help improve the approval process for pharmaceuticals and other medical products.

The poll also showed that the most trusted sources for medical research information are pharmacists (83% find trustworthy), patient groups (82%), CDC (79%) and their health care providers (78%). Americans also say they trust research information from NIH (61%). Yet only 17% say they regularly check government websites for medical research information, compared to 66% who consult commercial medical sites such as WebMD.

Interestingly, in asking respondents what the most important job is for the FDA to undertake (one being the most important), the survey found that:

-    59% believed the most important job is to protect the safety of Americans;

-    17% said the most important job is to provide accurate information to the American public about the benefits and risks associated with medicines;

-    16% said the most important job is to get new medicines and medical products to the American public; and

-    Only 7% said the most important job is regulating companies that produce medicines and medical products

In their press release, Mary Woolley, president and CEO of Research America noted that "public expectations for medical progress are very high” and that “Americans want new drugs and medical devices delivered faster, and they rightly want safety to be a top priority." To meet these expectations, she acknowledged the need for more resources at FDA, NIH, and the CDC, since the proposed 2011 budgets are not enough “to keep pace so they can fulfill their missions, and the public needs to let elected officials know how important these issues are."

When asked about attitudes toward the drug industry, over 51% of participants felt that the pharmaceutical industry has very positive or somewhat positive impact on improving American healthcare, while 56% believed that industry positively improved the health of themselves and their family.  Further support of the pharmaceutical industry showed that:

- 64% believe the pharmaceutical industry provides accurate information about the risks and side effects of their products very well or somewhat well.


- Almost 50% believe the pharmaceutical industry conducts clinical trials responsibly somewhat well. 

- 64% believe the pharmaceutical industry makes sure their products are safe and effective before bringing them to market very well or somewhat well.


- Almost 75% felt the pharmaceutical industry creates products that save lives and improve people’s quality of life very well or somewhat well.


- 63% responded that the pharmaceutical industry provides general medical safety information very well or somewhat well.

With the poll finding very strong support (94%) for the idea that institutions conducting medical and health research-government, universities and private industry-should work together, critics must reevaluate their concerns. In addition, 88% believed that pharmaceutical companies sometimes fund research conducted in conjunction with universities, hospitals and other institutions, and over 50% believe industry has a positive impact on improving healthcare. These numbers clearly demonstrate that working together, the public and private sectors can “bridge gaps and turn more early-stage discoveries into treatments faster.”

As a result,  there can be no question about what the proper role of industry in health care is: “Americans see such collaboration as leading to greater knowledge, better success rates and faster development of cures and treatments, as well as avoiding duplication and maximizing resources devoted to research and development.”


May 27, 2010

FDA: Off Label May Be the Wrong Label

The Food and Drug Administration (FDA) has acknowledged for years that "good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment.”  According to a recent article in Forbes, this knowledge has increasingly begun to consist of off-label prescriptions, which are sometimes necessary for the practice of good medicine.  


As the agency's website recognizes, “if physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects."


In addition, the American Medical Association (AMA) believes that "physicians have the training and experience necessary to determine the best or preferred method of treatment," including off-label prescribing, which is often be considered "reasonable and necessary medical care, irrespective of labeling." In fact, doctors can be subject to malpractice liability if they do not use drugs for off-label indications when doing so constitutes the standard of care.


Before a drug can be sold in the U.S., it must be certified by the FDA as safe and effective for a specific, or "on-label," use.  Once approved, although physicians may legally prescribe it for any other purpose (off-label), the manufacturers of such drugs are only legally able to educate and inform physicians about the “on-label” use.  Companies can re-apply through the FDA to have the original drug approved for additional uses.


But with companies recently dealing with huge settlements involving off-label fraud (Pfizer; Eli Lilly; and AstraZeneca), how exactly do physicians find this “firm scientific rationale” and “sound medical evidence?” It is especially hard for physicians and patients to learn about off-label usages of drugs because the FDA, with support from many in Congress, has sought repeatedly to limit physicians' and patients' discretion about treatment decisions, including restricting physicians from prescribing drugs off-label. Forbes described two examples.


First, the Food and Drug Administration Amendments Act (FDAAA), which took effect on March 25, 2008, gave the FDA sweeping new powers, which included the ability to require a Risk Evaluation and Mitigation Strategy (REMS) for any newly approved drug. According to the FDA, a REMS is "a strategy to manage a known or potential serious risk associated with a drug or biological product," which could be said to encompass virtually any medicine. FDA noted that a REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS."


Essentially, REMS made “off-label prescribing much more cumbersome and difficult” because for safe use of a drug, FDAAA consisted required that:


-   Health care providers who prescribe the drug have particular training or experience, or are specially certified;   

-   Pharmacies, practitioners or health care settings that dispense the drug are specially certified;     

-   The drug is dispensed to patients only in certain health care settings, such as hospitals;  

-   The drug is dispensed [only] to patients with evidence or other documentation of safe use conditions, such as laboratory test results;    

-   Each patient using the drug is subject to certain monitoring; and   

-   Each patient using the drug is enrolled in a registry."


In addition to these requirements that reduce physicians' off-label prescribing, FDA also restricts drug manufacturer promotion of off-label uses, which encompasses any and all contact with health professionals or patients. Manufacturers are only able to send peer-reviewed medical journal articles and excerpts from medical textbooks to physicians and are permitted to answer questions asked directly by physicians only under certain circumstances.


The second problem arose from an October 2009 lawsuit with Allergan drug Botox, which was approved for treating muscle spasms, but has been “widely used off-label” for other medical issues.  The company argued that the FDA is not authorized by the Federal Food, Drug and Cosmetics Act to “ban the distribution of truthful information about safe and effective off-label uses of medicines” because it would be an unconstitutional abridgment of commercial free speech. The federal District Court for the District of Columbia will hear oral arguments from the parties later this year, and a final decision could take years.


The trouble for Allergan and other companies was that FDA ordered the company to send detailed safety updates to physicians who prescribe Botox for both on-label and off-label indications. As a result, “the company felt that regulators had placed it in a Catch-22 situation: Complying fully with the order could violate the FDA ban on promoting drugs for off-label uses,” and result in significant fines that would threaten the company and its employees with criminal penalties.


FDA's off-label policies have raised concerns over the past decade.  In fact, “a federal district court held that the near-blanket ban on disseminating truthful and non-misleading information about off-label uses was an unconstitutional restriction of commercial speech.” The regulations were only maintained because FDA “claimed that the rules merely established a "safe harbor" under which manufacturers would be automatically deemed in compliance with the law, but that the regulations did not really prevent all off-label promotion.”  Then in 2009, the agency issued a guidance document that acknowledged explicitly that drug and device firms may sometimes distribute medical journal articles and text book excerpts to physicians.

It should also be noted that FDA has issued Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.  FDA also has Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.  Both of these documents provide significant resources and guidance for companies regarding off-label promotion of drugs.


With recent opinion polls by the Pew Research Center showing that Americans are dissatisfied with their government, the regulation of off-label prescriptions becomes an important issue because of how many patients it affects.  It is estimated, “on the basis of articles in medical journals and information gleaned from conferences” that doctors use off-label prescriptions almost “100 million times a year.” By some estimates, at least 20% of all prescriptions written are off-label, and those uses often constitute the accepted standard of care. For example, “the practice is well known in cancer and cardiac treatment, where as many as half of all prescriptions are for off-label uses. In the absence of off-label prescribing, physicians would have fewer treatment options and many patients would die or suffer needlessly.”


Moreover, a “series of national surveys commissioned by the Competitive Enterprise Institute has shown that a large majority of physician specialists--including oncologists, cardiologists, emergency room doctors, orthopedic surgeons and neurologists--believe the FDA's policies have made it more difficult for them to learn about new uses for drugs and medical devices, and that the agency should not restrict information about off-label use.” The authors recommend that the FDA should maintain a database of information about off-label uses of drugs to make it easier for physicians and safer for patients.


Doctors should not have to worry about being sued for not using drugs for off-label indications when doing so constitutes the standard of care, and they should not be restricted from learning about them either.  As the authors correctly assert, “these FDA policies compromise physicians' ability to learn about and use new pharmaceuticals,” and should be revised to reflect the important role off-label prescribing plays in the daily practice of numerous physicians. FDA should also consider how 100 million prescriptions are going to get filled without off-label prescriptions, and who is going to pay the legal costs for doctors who are prohibited or prevented from prescribing off-label usage of drugs.


Perhaps the term off label has the wrong label, perhaps it should be referred to as investigational use.

May 26, 2010

AMA CEJA: Strike 4 - Report Perhaps Ushered from the CME Ballpark

In its fourth attempt to soil independent CME grants provided by industry to advance competency and patient outcomes, the American Medical Association Council on Ethical and Judicial Affairs (AMA CEJA) is earning distinction for being one of the least credible sources of information in the CME enterprise.


In AMA CEJA Report #1, the authors confused Certified CME with promotional activities branded under the name “professional education.” Specifically, the first CEJA report stated that “professional education” included:


• “CME”

• “industry marketing and promotional activities”

• “personal expenses associated with attendance at meetings”

• “educational travel grants for medical students”

• “free lunches”

• “residency positions”

• “company speakers’ bureaus”

• “free or subsidized travel”


Unfortunately, the only thing on the list above that does qualify for physician credit and meet the definition for Certified CME is “CME.” Everything else is not Certified CME.  


Additional AMA CEJA reports on CME continued the confusion and borrowed misunderstood ideas from other national organizations. The AMA CEJA parroted the 2009 Institute of Medicine report that created the amorphous concept of “subtle bias” in CME: an undefined bias somehow created just by the very presence of industry grant funding, even though accreditation rules specifically require independence from any promotional influence and appropriate management of grant support.


The AMA CEJA took it a step further in its third (2009) report on CME. The CEJA report stated that grant funding soiled CME content by creating both “unconscious” and “subtle bias.”


There are two important non-sequiters plaguing these “subtle bias” arguments. First, if CME bias is so subtle that physicians can’t detect it, how is it that the authors of these reports can do so?


Second, the evidence cited by CEJA doesn’t hold up. The footnotes CEJA provides to support the connection between grant funding and CME bias don’t even relate to CME activities. One article is on “gifts to physicians from industry” from marketing/sales representatives. The second is a Harvard Business Review article on the 2002 Enron scandal and financial crisis addressing “Why Good Accountants Do Bad Audits” (erroneously titled by CEJA as “Why good accountants go bad”).


In spite mounting evidence and convincing studies showing little or no connection between bias and grant-funded CME, the AMA CEJA is back at the plate, swinging against industry education grants. The 2010 report ignores both the Medscape and comprehensive Cleveland Clinic CME studies showing that 98% of physician attendees considered CME to be free of bias, whether or not industry grant funding was provided.  In addition, the 2010 AMA CEJA report continues to erroneously cite and footnote information. Evidence based? Not AMA CEJA.


Ironically, a different group within the AMA appears diametrically opposed to AMA CEJA. In April, the AMA hosted National Task Force on CME Provider/Industry Collaboration produced a “Get The Facts” campaign that sets the record straight with a toolkit and series of fact sheets. This is an excellent step in clarifying what CME is and what it is not.


The four AMA hosted National Task Force Fact Sheets on CME address the following:


· CME: Providing Valid and Independent Evidence for Clinical Decisions

· Addressing Conflict of Interest through Disclosure and Resolution

· Commercial Support of CME and Compliance with Guidelines

· Appropriate Discussion of Off-Label Drug Use within CME


In its announcement of the Get The Facts campaign, the National Task Force plainly stated the perception problem we face in the CME enterprise:


“The media, state and federal law and policy makers as well as regulators and other ‘collective/consensus opinions’ frequently use and disseminate information that can lead to incorrect assumptions and false perceptions about CME. This has led to increased regulatory scrutiny and critical public opinion regarding CME practices.”


The more AMA CEJA pitches out reports that lead to “incorrect assumptions and false perceptions about CME,” the more the AMA Task Force and the rest of us have to field unfounded accusations and criticism.


After four strikes against CME without factual support, it’s time for AMA CEJA to either play by the rules of evidence or leave the ballpark. Let AMA CEJA know they are harming patients by playing games with unfounded accusations about CME support.



By Stephen M. Lewis, MA, CCMEP


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