Life Science Compliance Update

June 08, 2017

AccessRx FAQs Posted on DC Department of Health Website


In April 2017, the Department of Health (DOH) in the District of Columbia (D.C.) quietly posted Frequently Asked Questions (FAQs) regarding AccessRx reporting requirements. AccessRx requires manufacturers and labelers of prescription drugs that are dispensed in D.C. who engage in marketing in D.C. to report to the Department of Health their costs for pharmaceutical drug marketing in D.C. Under the regulations, manufacturers and labelers are required to report their prescription drug marketing costs in an annual report filed with the DOH on or before July 1 of each year.

The FAQs range from simple questions, such as who is required to report and when the reporting deadline is (answers noted above) to more complex questions, such as how the “activity date” should be reported (answer below).

Submission Timeline

The FAQs also address the problem of late submissions – they are accepted, but must be approved by the Program. For permission, manufacturers and labelers can email – and what file format AccessRx reports should be in (Microsoft Excel – the DOH specifically requests that reports are not submitted as PDFs and that the file not be password-encrypted).

Is Double Reporting Required?

One FAQ touches upon whether payments to physicians and teaching hospitals that are reported to Open Payments should also be reported to AccessRx. The DOH answers no, physician and teaching hospital payments should not be reported to both Open Payments and AccessRx. Manufacturers are not required to report payments through AccessRx if they have been reported to Open Payments and CMS. In fact, payments to physicians and teaching hospitals should only be reported to AccessRx in very special circumstances, when they have not been reported to Open Payments.

Reportable Gifts

According to the FAQs, gifts – including food and beverages – given to physician offices and/or medical practices should be attributed to named individuals or entities. Expenditures to physician offices or medical practices that cannot be reasonably allocated to individuals may be reported as a group or non-individual gift; however, expenditures on gifts to physicians must be excluded. Gifts given to an entire office or practice should not be reported as a gift to an individual but should be reported as a non-individual gift. However, gifts given to physicians should not be rolled into gifts to a group. Further, gifts to physicians reportable to Open Payments should not be reported to AccessRx.

Advertising Expenses

When it comes to reporting advertising expenses, the “Activity Date” can be reported in ranges. “Activity date” refers to when the advertising took place. For television or radio advertisements, the date reported should correspond to when the activity happened, and the payment amount should correspond to the cost of the activity. For mailings or email promotion, the date could be when the materials were mailed or sent out.


Even if a manufacturer did not make payments to healthcare providers in D.C., the manufacturer is not required to submit gift expenses to AccessRx. However, the manufacturer must still report aggregate and advertising expenditures to AccessRx if the manufacturer utilized detailers or employed/contracted with anyone who was engaged in marketing or advertising in D.C.

The annual report is to be submitted with a filing fee of $5,000.00, which is payable exclusively by check and checks are to be made payable to the D.C. Treasurer. Such a hefty filing fee (one that is required by any manufacturer/labeler who markets or advertises in D.C.) leads one to think that this isn’t about transparency or any other reason D.C. and others give for reporting requirements, but instead is as a cash cow to line the city’s financial coffers.

April 16, 2013

AMSA Expanding Anti-Industry Scorecard to 400 Teaching Hospitals

Teaching Hospitals
We recently reported on a survey of 1,610 first- and third-year medical students and 739 residents regarding conflict of interest (COI) policies and their interactions with industry.  In our story, we noted that almost every year, the American Medical Students Association (AMSA) publishes a yearly “PharmFree Scorecard” that evaluates the COI policies at American medical schools.  Here is a little background and history on AMSA.

The PharmFree Scorecard is funded through the Consumer and Prescriber Education grant program, which resulted from the Neurontin settlement back in 2004.

It is because of organizations like PharmFree that frame all physician-industry collaboration as negative or unethical, that patients, physicians and biopharmaceutical professionals need a voice in the “conflict of interest mania,” such as the recently launched Partners for a Health Dialogue.  

Interestingly, while we cited to the 2012 results, AMSA just released its 2013 Scorecard, the sixth iteration of the scorecard.  The release comes as AMSA hosts its National PharmFree Week April 8-12, 2013.  The annual event “highlights the importance of putting patients first by addressing conflicts of interest and encouraging evidence rather than marketing-based education.”  Below is a summary of this year’s findings as well as additional information about AMSA activities. 

Interestingly, AMSA and Pew announced with this year’s data that they were also charged through a grant from the Oregon State Attorney General’s office to update the AMSA PharmFree Scorecard and expand it to 400 teaching hospitals.  Alongside Dr. Joseph Ross of Yale Medical School who served as a Methodology Consultant, AMSA and Pew developed the new AMSA PharmFree Scorecard set for release in 2014.  Given that payments to teaching hospitals must be reported under the Physician Payment Sunshine Act, the new scoring of teaching hospitals will bring increased scrutiny to physician-industry interactions at such hospitals.  

There will be two versions of the new Scorecard - one for medical schools and another for teaching hospitals.  The number of domains for the Scorecard has also expanded with 16 domains common to both versions and 2 additional domains for “Samples” and “Purchasing and Formulary Committees” specific to the teaching hospital version.  Other revisions to the Scorecard will include a new formula for assessing academic medical centers as well as revisions in the framework for grading schools.


2013 Findings


“Conflict of interest policies discourage inappropriate relationships and allow transparent and positive industry-physician collaborations to thrive,” said Daniel Carlat, director of the Pew Charitable Trusts’ prescription project, which supports AMSA’s work. “The 2013 scorecard shows medical schools are moving toward stronger conflict-of-interest standards.”


As of April 9, 2013, 153 out of 158 medical institutions considered eligible for grading have participated in the Scorecard, a 97% participation rate.  Of these 158 US medical schools, 40 receive “A”s (25%), 75 “B”s (47%), 14 “C”s (9%), and 13 “D”s (8%).  Thus, 115 of 158 medical schools (73%) now receive a grade of A or B for their COI policies, compared with 102 last year.  Approximately 8% of U.S. medical schools improved their COI policies since the 2011-2012 Scorecard.


Policies that apply only to medical students and/or residents, but not faculty, and (2) Policies that are only guidelines, without formal requirements, may only achieve a maximum grade of C.


13 schools (8%) receive a grade of F.  This includes 3 schools that submitted policies graded as F, two schools that stated they had no COI policy in place, and five schools that did not respond to repeated attempts at follow-up in 2008, 2009, 2010, 2011-12 and 2012-2013.  Three additional schools received an F as they did not submit new policies or demonstrate a continuing policy development process after remaining In Process for one year.  Three schools (2%) received a grade of In Process.  Here are some highlights from this year’s report:


  • Roughly 80% of medical schools have perfect or close to perfect policies for on-campus CME.
  • Only 4 medical schools – Univ. of South Dakota Sanford School of Medicine, Florida State Univ. College of Medicine, Stony Brook Univ. School of Medicine, and the Commonwealth Medical College -- completely ban sales representatives from campus.
  • Only 41 schools (26%) have model policy in terms of disclosure, requiring personnel to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and disclosing these relationships to patients.
  • All 8 of the Texas medical schools scored at least a B.  The University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state. All three of the Maryland medical schools scored at least a B, with both Johns Hopkins and University of Maryland Schools of Medicine receiving an A.
  • Schools with model policies on speaking arrangements have grown tremendously; 44 schools ban or severely restrict participation in speaker bureaus.


Specifically, 18 schools have banned participation by their faculty on speakers’ bureaus: Harvard Medical School, NYU School of Medicine, Duke Univ. School of Medicine, Columbia Univ. College of Physicians and Surgeons, Univ. of Arkansas School of Medicine, Univ. of Maryland School of Medicine, Georgia Health Sciences Univ., Univ. of South Carolina School of Medicine, Univ. of Hawai’i John A Burns School of Medicine, Creighton Univ. School of Medicine, Wake Forest Univ. School of Medicine, Univ. of Massachusetts Medical School, Emory Univ. School of Medicine, Stanford Univ. School of Medicine, Albert Einstein College of Medicine, Univ. of Alabama Birmingham, Univ. of Florida and Jefferson Medical College.


The following is a list of domains and the number of perfect scores in each in 2013:


  • 28 Schools have perfect scores for “On-campus continuing medical education;” improved from 20 in 2011-2, 15 in 2010, 3 in 2009 and 5 in 2008.  On-site education means within the medical school or hospital campus.  To gain a perfect score, “Industry is not permitted to provide direct financial support for educational activities, including CME, directly or through a subsidiary agency.  (However, companies may contribute unrestricted funds to a central fund or oversight body at the AMC, which, in turn, would pool and disburse funds for programs that are independent of any industry input or control.)”


  • 98 medical schools have “Less stringent limitations to ensure independence of educational content (e.g., standards to establish freedom from industry influence of content, such as review and approval of presentations; language that prevents industry from selecting the speaker; a requirement that programs adhere to ACCME standards; or language such as: industry funding may be allocated for a particular topic, but must be provided directly to the department, not to individuals).  Despite trying to discredit the ACCME as a “non-governmental” organization, CMS recently recognized the critical importance of the ACCME Standards for Commercial Support in the final Sunshine Act rule, and non-compliance with such standards can result in loss of accreditation. 


  • Off-campus continuing medical education –  102; improved from 88 in 2011-2, 75 in 2010, 49 in 2009 and 23 in 2008.  Off-site education is at outside facilities, including professional conferences.  AMSA measures this category based on how schools regulate compensation for travel or attendance at off-site lectures and meetings.  To gain a perfect score, “Personnel may not accept payment, gifts or financial support from industry to attend lectures and meetings. (An exception may be made for modest meals, if part of a larger program.)  Travel support may only be accepted if it is subject to institutional approval or industry is prevented from selecting (“earmarking”) the recipients.”  It is unclear, however, whether this category captures accredited CME or simply all off-campus educational events.


  • Scholarships & Funds for Trainees – 123; improved from 108 in 2011-2, 94 in 2010, 66 in 2009 and 29 in 2008.  To gain a perfect score, “The policy must either prevent industry from earmarking or awarding funds to support the training of particular individuals (recipients must be chosen by the school or department), or the policy must mandate institutional review of the giving of funds. (This does not preclude grants that fund a specific research project.)”


  • Gifts & Meals – 93; improved from 81 in 2011-2, 66 in 2010, 44 in 2009 and 19 in 2008.  To gain a perfect score in Gifts & meals, “All gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”  Less stringent include limitations such as prohibitions above $50 per year, or gifts prohibited but meals allowed.


  • Disclosure – 41; improved from 29 in 2011-2, 20 in 2010,  5 in 2009 and 1 in 2008.  To gain a perfect score, “Personnel are required to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and/or disclose such relationships to patients when such a relationship might represent an apparent conflict of interest.”


  • Curriculum – 79; improved from 69 in 2011-2, 48 in 2010, 28 in 2009, and 12 in 2008.  To gain a perfect score, “Students are trained to understand institutional conflict-of-interest policies and recognize how industry promotion can influence clinical judgment.”


  • Consulting (excluding scientific research and speaking) – 71, improved from 64 in 2011-2, 49 in 2010, 27 in 2009, and 12 in 2008.  To gain a perfect score, consulting relationships “must be subjected to institutional review or approval. Additionally, they must either be described in a formal contract, or payment for services must be commensurate to the task.” 


  • Sales representatives – 4; improved from both 2 in 2011-2 and 2010, and both 1 in 2009 and 2008.  To gain a perfect score, “Pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”


  • Purchasing & Formularies – 83; improved from 70 in 2011-2, 66 in 2010, 47 in 2009, and 22 in 2008.  To gain a perfect score, “Formulary committees and committees overseeing purchases of medical devices should exclude those who have financial relationships with drug or device manufacturers.  Exclusion may be specific to participation in particular decisions for which the staff member has a conflict of interest.  This policy does not prevent expert clinicians from advising a committee, provided that potential conflicts are disclosed.  (Note: this standard is not intended to prohibit indirect financial interests, such as investments in mutual funds that may own pharmaceutical company shares).”  


  • Samples – 42, improved from 31 in 2011-2, 26 in 2010, 20 in 2009, and 12 in 2008.  To gain a perfect score, “Industry samples are prohibited, except under certain narrow circumstances approved by the institution that protect the interests of patients and prevent the use of samples as a marketing tool (e.g., policies that allow samples under limited circumstances with the approval of the Pharmacy and Therapeutics (P&T) Committee or policies that incorporate samples into a larger program designed to ensure the availability of brand-name and generic medications to under-insured patients; if the circumstances of the specific program are not defined, the policy should define the approvals process). Where there is a specific program in place, the policy must prevent samples from being given directly to physicians by pharmaceutical sales representatives.”


  • Industry-funded speaking – 44; improved from 31 in 2011-2, 19 in 2010, 10 in 2009, and 4 in 2008.  To gain a perfect score, “Speaking relationships are prevented from functioning as de facto gifts or marketing.  An effective policy must not implicitly permit (a) long-term speaking agreements or (b) industry to have a role in determining presentation content.  (Some effective policies may explicitly prohibit participation in a speakers bureau.  Other effective policies contain elements such as limits on compensation and reimbursement and a requirement to ensure the scientific integrity of information presented.)”


Similar to the results of the past, the areas that garnered the greatest number of perfect scores were those addressing industry support of scholarships, off-campus “CME,” faculty participation in industry-speaking relationships, purchasing and formulary committees, and gifts.  Industry support of scholarships experienced the largest net growth in achieving perfect scores in this domain (15 additional medical schools).  New areas being addressed by schools include samples as well as purchasing and formula committees.  AMSA says that “on-campus CME remains a challenging area.


Regional Trends

Californian medical schools continued to excel with 7 of their 10 schools receiving an A grade.  This is in part due to the strong system-wide University of California (UC) COI policy, which when graded on its own receives an A grade.  However, some of the UC schools go even further by supplementing the system-wide policy with their own regulations.  Texan schools continue to show significant improvement.  All eight Texan medical schools score at least a B.  University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state.


Another major training ground, Massachusetts, continues to show case schools with model policies. This year, University of Massachusetts Medical School and Boston University both received a B grade while Harvard Medical School and Tufts University School of Medicine both received an A grade.


The nine Pennsylvania medical schools have strong policies and in Maryland, all three schools (Johns Hopkins University, University of Maryland, and Uniformed Services of the Health University) received a B grade or higher.  Finally, the state of Florida continues to perform well.




The PharmFree Scorecard methodology was developed jointly by AMSA and the Pew Prescription Project, an initiative of the Pew Health Group.  Assessed domains are broadly consistent with those identified in recent literature – primarily Brennan et al. Health Industry Practices that Create Conflicts of Interest:  A Policy Proposal for Academic Medical Centers.  JAMA 2006; 295(4): 429-433.


The Scorecard assesses policies related to: (1) acceptance of gifts and meals from industry; (2) consulting relationships; (3) speaking relationships; (4) disclosure of financial conflicts; (5) pharmaceutical samples; (6) individuals with financial conflicts participating in university purchasing decisions; (7) financial support for educational events (on- and off-campus); (8) industry support for scholarships and trainee funds; (9) access of industry sales personnel to medical school or hospital personnel; and (10) inclusion of education about conflict of interest within the academic curriculum. Additionally, the presence of oversight and sanctions is examined, but not included in grade calculation.


AMSA maintains that “Two blinded assessors independently score each set of policies in the eleven areas included in the scorecard.”  How can such assessors be blinded if they are working for AMSA/Pew, and are clearly anti-industry and biased towards any kind of industry interactions or collaboration?


Other AMSA Initiatives


Of particular interest is a new initiative known as the “2nd Slide Campaign,” which is based off the standard practice in graduate and continuing medical education (CME) to disclose conflicts of interest on the 2nd slide of one’s presentation.  “The premise of this campaign is simple: medical students should receive the same types of disclosures that educators provide in other types of medication.”  AMSA notes that “most medical schools lack clear guidelines to help faculty members disclose conflicts of interest to students.”


AMSA provides a sample disclosure slides and other information for medical students to bring about change in their medical schools. AMSA provides three scenarios for when a lecturer should disclose interests to students, and tailors their example disclosure slides to such scenarios:


-          Lecturer has conflicts of interest but they are not relevant

-          The lecturer has no conflicts of interest

-          The lecturer has relevant conflicts of interest to disclose to the students 

AMSA said that such disclosures matter because it is “vital” that medical students and “know where information comes from.”  AMSA calls for such disclosure because “research shows that financial conflicts of interest can impact (even subconsciously!)the presentation and interpretation of data.”  AMSA also has resourcs for a PharmFree Curriculum and “Best Practice Policies,” such as for gifts, meals, and samples.  

Given the already hurried schedules of physicians and medical students, will there really be enough time for medical professors to address and discuss potential conflicts with students?  Will such disclosures even matter to students?  It seems more appropriate that this subject be clearly addressed in a standard medical ethics course over the course of medical school, not during each lecture given, particularly in light of the Sunshine Act, which will allow medical students to do their own research on professors, if they desire.   

One interesting new program that AMSA appears to have started is the “National Opt Out Day.”  Specifically, AMSA “asked graduating fourth year members to tell the American Medical Association (AMA) that they are opting out of the AMA Physician Masterfile!”  “As physicians who strive to practice evidence-based medicine, we do not want our personal and prescribing information sold to the pharmaceutical and medical device industries.”  The AMA Physician Masterfile was established by the AMA in 1906 as a record keeping device supporting membership and mailing activities. The Physician Masterfile includes current and historical data for more than 1.4 million physicians, residents and medical students in the United States. 

AMSA also hosted a webinar with the University of Miami Miller School of Medicine to discuss how the school improved their conflict of interest policies as well as the barriers both current and past to implementing change.  Executive Dean of Education and Policy Dr. Laurence Gardner will be presenting

AMSA noted that in addition to Pew, it has joined forces with the National Physicians Alliance (NPA) and Community Catalyst to create both external and internal pressure for medical schools and academic medical centers to adopt strong COI policies, through a new initiative- the Partnership to Advance Conflict-Free Medical Education (PACME).  They noted how NPA’s Unbranded Doctor campaign provides resources for conflict-free medical practice including an archive of past events including bimonthly Conflict-Free Leadership Calls and National Grand Rounds

Community Catalyst is in the process of developing a series of toolkits to help institutions improve their policies with examples of language from other model institutions and provides technical assistance to schools via regional roundtable and individual consultation.



November 03, 2011

AHRQ National Resource Center for Academic Detailing

Academic Detailing 3 
The rate at which medicine, science and technology advance our current health care system is rapid.  Each day, more and more companies are filing applications to begin research and clinical trials and new drugs, devices, biologics, vaccines, and treatments that will one day hopefully cure cancer, AIDS/HIV, and assist in managing chronic diseases such as asthma, heart disease, diabetes and obesity.

However, these advances do not happen overnight, and the time it takes to get them from the bench to the bedside is a long and extremely difficult process.  And it’s not cheap.

Practicing physicians and clinicians in the American healthcare system are already overwhelmed and overburdened.  Reimbursement rates are at an all time low, malpractice insurance costs are soaring, overhead for running private practices make it almost impossible for small groups of physicians to keep their heads above water, and the massive changes coming to our healthcare system as a result of the Affordable Care Act have left everyone very confused.

While all of these issues create a perfect storm of difficulties in our health care system, the role of industry and physician-collaboration and relationships have also raised concerns, especially with respect to marketing and detailing.

Marketing and detailing is a process by which drug and device manufacturers educate and inform practicing physicians and clinicians about new products, treatments, devices, and clinical data regarding a specific product that has been approved by the Food and Drug Administration (FDA).  The process of detailing, although not perfect, and subject to recent federal prosecution and significant regulation, is extremely important for physicians who spend their busy days treating patients every 15 minutes.

Yet, some believe that marketing and detailing raises costs to our healthcare system and raises issues of bias and conflicts of interest.  Many argue that detailing leads to the use of brand name drugs and higher prescription costs, as well as the use of products that have significant risks for patients.  These claims are heavily misguided considering over 75% of prescription drugs in the U.S. are generic. 

Academic Detailing

Over the past few decades, an effort to counter detailing has begun to grow.  Academic detailing“ was pioneered by Jerry Avorn and others over 30 years ago as a “method of educational outreach that provides prescribers with accurate, non-commercial, and relevant data on medications in a user-friendly, interactive format that is proven to change practice.”

Academic detailing is noncommercial education of health care professionals, typically conducted by physicians, pharmacists, and nurses, about the evidence-based efficacy, safety, and cost of therapies.  It is designed to counter detailing by pharmaceutical and device manufacturers, which critics contend can be biased because of commercial interests.

Consequently, the academic detailing movement has begun to pick up.  “In fact, a recent initiative was funded and supported by a grant from the Agency for Healthcare Research and Quality (AHRQ). 

The grant is part of funding from the American Recovery and reinvestment Act, which gave the Department of Health and Human Services (DHHS) $1.1 billion to conduct comparative-effectiveness research designed to compare therapies for various conditions to determine what treatments work best.  Consequently, DHHS spent $300 million through AHRQ, in part to conduct an Academic detailing Initiative.

The program, known as the National Resource Center for Academic Detailing (NaRCAD), has the goal of promoting “the use of evidence-based medicine by supporting programs of academic detailing.” According to their website, NaRCAD:

-          Promotes the use of evidence based medicine by supporting the establishment and improvement of academic detailing programs.

  • NaRCAD provides training, materials, and consultative support to health care organizations to establish effective academic detailing programs.
  • NaRCAD aims to establish a network of programs sharing best practices in academic detailing to further the use of comparative effectiveness data in medical practice.

Consequently, the AHRQ grant and NaRCAD also got recent attention in an article in the Journal of the American Medical Association (JAMA).  Unfortunately, the article is very slanted in its portrayal of detailing.  For example, the author cites data from 1995, which showed that “11% of statements made by drug company detailers about drugs contradicted information readily available to them.”  In the almost 17 years since that research was conducted, monumental changes in the industry and because of government regulations and legal cases have significantly changed the nature of statements detailers can make.  As such, this kind of past abuse is almost non-existent.

AHRQ is also funding a number of other programs including:

  • Total Therapeutic Management Inc. (a quality improvement company providing outcomes research) to provide in-person visits to clinicians and health care system decision makers to help them understand and use comparative effectiveness research.
  • Ogilvy Public Relations to create a publicity center to promote the academic detailing resources and to establish dissemination partnerships with national organizations, as well as establish regional dissemination centers to enhance awareness and use of academic detailing;
  • Prime Education Inc, which will provide continuing medication education (CME) to clinicians. A fourth entity; and
  • IMPAQ International, which will determine the effectiveness of the 4 projects

How NaRCAD Works

The website notes that, “despite the availability of a growing body of comparative effectiveness research (CER) weighing the risks and benefits of therapies in a wide range of clinical areas, non-evidence-based medical care is common.”  Accordingly, NaRCAD provides organizations with support and guidance in establishing new academic detailing programs, as well as evaluating and improving existing ones.

  • The Center works with partner organizations to perform a needs assessment of their current patterns of medical care and lay the groundwork for establishing academic detailing programs.
  • Our core staff and clinical specialty consultants adapt AHRQ’s CER findings for important clinical areas (including diabetes, use of anti-psychotic drugs in dementia, pain control in arthritis) into tools that can be used for effective academic detailing.
  • The center provides training sessions on the principles of social marketing, techniques of academic, and the clinical content of the adapted CER findings.  These sessions will be offered on multiple occasions over the coming months and years.
  • NaRCAD works with each partner organization to evaluate its academic detailing activities across multiple dimensions. We collaborate with programs to gather qualitative data on the process of implementation, the quality of training, and the experiences of clinicians receiving the academic detailing messages.  The resource center also provides guidance to participating programs on performing patient-level assessments of the impact of their interventions.

The website notes that, “guidance on the establishment of detailing programs, training on the techniques and content of academic detailing, assistance in the evaluation of program effectiveness and the provision of adapted AHRQ review material will help organizations to transform evidence-based information into improved patient-care decisions.” 

Network for Academic Detailing

Consequently, the website notes that, “NaRCAD is establishing a network of organizations seeking to implement the findings of AHRQ’s CER work in their own settings.” Organizations that have already implemented academic detailing or other innovative educational program are welcome to partner with NaRCAD and to take advantage of the training and resources that the center provides.

NaRCAD aims to create a community of programs using academic detailing to disseminate non-commercial, evidence-based information on the benefits and risks of  treatment options. This sharing of ideas will enable us and partner organizations to identify best practices that lead to successful academic detailing programs, as well as pitfalls to avoid.  By sharing information in this manner, NaRCAD will facilitate the development and improvement of academic detailing programs nationwide.

After 3 years, the AHRQ hopes to have enough data to enable it to understand the impact of the academic detailing process, the development of partnerships, the types of outcomes it can expect during different phases of the project, and the influence of various detailing methods on health care worker behavior. 

Jean R. Slutsky, PA, MSPH, director of AHRQ’s Center for Outcomes and Evidence, said the initiative is targeted at primary care physicians working in small and large practices. “We are bringing unbiased, high-quality information to health care professionals. It is really face-to-face education with trained professionals who have no conflicts of interest who are trained in how to discuss the information,” Slutsky said. 

“A key message we try to bring is the balance of benefits and harms of different health care interventions—allowing primary care providers to understand where one option may provide more of a benefit than another option,” Slutsky said. 


Consequently, while this program may be important to educate doctors, it is equally important, especially in light of the recent Supreme Court decision in IMS v. Sorell, that academic detailing does not attempt to discredit other forms of education, particularly traditional forms of detailing and promotion. 

Industry regulations such as the PhRMA and AdvaMed Codes of Ethics, as well as oversight from HHS OIG, FDA, DDMAC, and DOJ, all ensure that the future of marketing, promotion and education will be of the highest quality and integrity, and most importantly, will be truthful.

In fact, the Pharmaceutical Research and Manufacturers of America (PhRMA) addressed the issue in a statement it made last year regarding a hearing in the Minnesota legislature about health care legislation. In the statement, PhRMA Senior Assistant General Counsel Marjorie Powell said, “The final proposal could expand academic detailing programs that, elsewhere, exist solely to boost the number of generic drugs that physicians prescribe.” 

Powell noted that this kind of “single-minded focus raises the question of the merit of such a program in Minnesota, where generic dispensing rates already approach 80%.”  Furthermore, while the industry has specific required regulations and policies,someself-imposed and some required by government, that they need to adhere to when presenting information. 

However, as Powell recognized, “counter-detailing is not subject to rigorous federal oversight, which requires that the information shared with physicians be accurate, fair, balanced, and reflect the federally approved medicine label.” 

Echoing the cost-pressure concern is Joshua D. Lenchus, DO, RPh, an associate associate professor of clinical medicine at the University of Miami Miller School of Medicine and associate director of the University of Miami-Jackson Memorial Hospital’s Center for Patient Safety in Florida. In a legal backgrounder for theWashington Legal Foundation wrote, “Physicians and other medical professionals are certainly conscious of the cost of drugs and medical devices, but our primary duty is to provide each patient with the care best suited to them individually. Tools such as comparative effectiveness research and academic detailing have been developed and applied in response to intense political and fiscal pressure to reduce health care costs”

Ultimately, as the Supreme Court recognized in IMS, “the fear that people would make bad decisions if given truthful information cannot justify content-based burdens on speech.”  

The Court explained that “many listeners find detailing instructive,” and that while some people and States may be displeased that detailers with prescriber-indentifying information are effective in promoting brand name drugs, “the State may not burden protected expression in order to tilt public debate in a preferred direction.”  Accordingly, academic detailing should keep these points in mind as they move forward.


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