AMA Delegate's Report 2014
The Interim Meeting of the American Medical Association (AMA) House of Delegates (HOD) was held in at the Hilton Anatole Hotel in Dallas, TX from November 7 through November 11. As usual, resolutions and reports regarding pharmaceuticals and medical devices were a significant part of the meeting agenda. Among more than 120 national medical specialty societies (and more than 50 state and territorial medical societies) represented in the AMA House of Delegates our Academy of Physicians in Clinical Research (APCR) is the only one for which pharmaceutical and medical device research is the primary focus.
AMA Executive Vice President (EVP) Jim Madara announced that AMA membership has increased for the fourth straight year.
Issues relevant to physicians in clinical research a proposed revision of the AMA Code of Medical Ethics, a Council on Ethical and Judicial Affairs (CEJA) report proposing guidance on the use of drug samples, a revised AMA stance on FDA regulation of off-label drug promotion, multiple resolutions expressing AMA Concern about the cost of drugs, and a Council on Science and Public Health (CSAPH) report on genomics in the treatment of hypertension. As of today, the complete meeting website is located here. Final actions on each item are available as part of the annotated Reference Committee reports, which can be seen by going to the meeting website, clicking on “Reports and Resolutions”, and then clicking “proceed” on the following screen. Also available on the meeting website are the AMA EVP’s report highlighting accomplishments on AMA’s three major initiatives (patient outcomes, medical education, and physician practice sustainability).
PROPOSED REVISION OF AMA CODE OF MEDICAL ETHICS
CEJA has been working on an updated AMA Code of Medical Ethics since 2008. CEJA Report 3 presented that body of work.
Most of the testimony was on the chapters regarding Patient-Physician Relationships and Consent, Communication & Decision Making. There were only minimal comments on the chapter addressing Research & Innovation. The delegates referred the report back to CEJA with a request that the current draft of the updated code and feedback received to date remain posted for further comment until December 31, 2014 and that CEJA revise the document for presentation at the June 2015 meeting of the AMA House of Delegates. These materials likely will be posted on a section of the AMA website accessible only to AMA members. A copy of the chapter addressing Research & Innovation is available from your AMA delegate.
Council on Ethical and Judicial Affairs (CEJA) Report 2 examined the benefits and challenges of prescribing and dispensing sample medications. The report offered guidance to physicians regarding responsible practice when prescribing and dispensing sample medications. Testimony centered on the burdens that some of the recommendations in this guidance could impose on physician practice. The report was referred back to CEJA. (Unlike recommendations in reports from other AMA Councils, recommendations from CEJA cannot be amended on the floor of the House of Delegates (HOD). Recommendations in CEJA reports must be adopted or referred back to CEJA.)
FDA REGULATION OF OFF-LABEL DRUG PROMOTION
By adopting the recommendations of Board of Trustees (BOT) Report 5, the House of Delegates revised and simplified long-standing policy balancing the need of physicians to access information about off-label uses with the need to ensure that such information is not presented out of context. A representative of the Pharmaceutical Research and Manufacturers of America (PhRMA) testified before the reference committee. AMA policy on this issue now reads as follows:
(1) The AMA confirms its strong support for the autonomous clinical decision-making authority of a physician and that a physician may lawfully use an FDA approved drug product or medical device for an off-label indication when such use is based upon sound scientific evidence or sound medical opinion; and affirms the position that, when the prescription of a drug or use of a device represents safe and effective therapy, third party payers, including Medicare, should consider the intervention as clinically appropriate medical care, irrespective of labeling, should fulfill their obligation to their beneficiaries by covering such therapy, and be required to cover appropriate “off-label” uses of drugs on their formulary.
(2) Our AMA strongly supports the important need for physicians to have access to accurate and unbiased information about off-label uses of drugs and devices, while ensuring that manufacturer-sponsored promotions remain under FDA regulation.
(3) Our AMA supports the dissemination of generally available information about off-label uses by manufacturers to physicians. Such information should be independently derived, peer reviewed, and scientifically sound, and truthful and not misleading. The information should be provided in its entirety, not be edited or altered by the manufacturer, and be clearly distinguished and not appended to manufacturer-sponsored materials. Such information may comprise journal articles, books, book chapters, or clinical practice guidelines. Books or book chapters should not focus on any particular drug. Dissemination of information by manufacturers to physicians about off-label uses should be accompanied by the approved product labeling and disclosures regarding the lack of FDA approval for such uses, and disclosure of the source of any financial support or author financial conflicts.
(4) Physicians have the responsibility to interpret and put into context information received from any source, including pharmaceutical manufacturers, before making clinical decisions
(e.g., prescribing a drug for an off-label use).
(5) Our AMA strongly supports the addition to FDA-approved labeling those uses of drugs for which safety and efficacy have been demonstrated.
(6) Our AMA supports the continued authorization, implementation, and coordination of the
Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
AMA CONCERN ABOUT THE COST OF DRUGS
The House of Delegates (HOD) adopted Resolution 206 asking that AMA work toward eliminating the Medicare prohibition on drug price negotiation.
Resolution 207 regarding Generic Pharmaceutical Pricing and Resolution 228 about the high cost of drugs were referred for report at a future meeting of the HOD. These resolutions asked that AMA advocate for prescription drug cost containment, and communicate concerns about the rapidly rising cost of generic prescription drugs to the FDA; that AMA advocate for a comprehensive federal government (e.g., CMS, etc.) study of the development and pricing practices of the pharmaceutical industry and inform Congress if any questionable pricing practices are discovered; and that AMA explore the rapidly escalating cost of generic drugs that are years past developmental costs.
It was noted that FDA does not have a role in containing drug prices. Several examples were cited where FDA approval of a New Drug Application (NDA) for one manufacturer’s version of a drug resulted in versions marketed by other manufacturers being forced off the market. On more than one occasion the outcome was a significant increase in the price of the drug. Earlier this year, in response to a resolution offered at the June 2014 meeting of the HOD, the AMA Board of Trustees adopted new policy asking that AMA:
(1) Raise awareness among physicians of the strategy that could be used to limit the value to manufacturers of forced switching of brand formulations of prescription drugs.
(2) Advocate that the FDA and Congress ascertain the pervasiveness of this practice and advance solutions that strike an appropriate balance between innovation incentives and competition in order to support patient access to the newest treatments as well as those that are cost-effective.
Resolution 220 asked that “AMA engage other stakeholders, which may include, but not be limited to FDA, the Executive Branch, Congress, consumer and public advocacy organizations (e.g., AARP, Public Citizen) or other non-governmental organization, and other appropriate stakeholders for the purpose of educating stakeholders and developing and implementing strategies to protect access for patients to effective, safe, and affordable drugs in the face of the pharmaceutical industry’s current practices.” This Resolution was not adopted.
Resolution 224 asked that AMA pursue legislation to require that FDA bioequivalence data be included in the package inserts of generic drugs. This resolution was not adopted.
Resolution 229 focused on one company’s plan to “to increase profits by restricting the distribution of their medications.” In lieu of this resolution, the HOD reaffirmed more general policy regarding reducing prescription drug prices.
Resolution 923 asked that AMA advocate for including the source country of the active pharmaceutical ingredients and finished dosage form on the labels of all medications available to American consumers. This resolution was not adopted.
GENOMICS IN THE TREATMENT OF HYPERTENSION
The HOD adopted the recommendations of Council on Science and Public Health Report (CSAPH) establishing new AMA policy that:
(1.) AMA encourages continued research on the genetic control of blood pressure and the development of genomic-based tools that may assist health professionals in better predicting risk and targeting therapy for hypertension.
(2.) AMA supports the view that hypertension clinical trial designs should attempt to reduce phenotypic heterogeneity in order to improve the quality and interpretation of results.
ANNUAL AMA RESEARCH SYMPOSIUM
APCR members may be especially interested in reading about the AMA research symposium for medical students, residents and fellows in the AMA Wire Newsletter. This symposium is held each year on the day preceding the November meeting of the AMA House of Delegates. The 2014 symposium was the largest ever with more than 400 contestants.
It is a great honor to represent the Academy of Physicians in Clinical Research in the AMA House of Delegates. Especially gratifying to me is the increase in the number of medical students who now attend the AMA meeting. My own medical school (Johns Hopkins) sent twenty students to this meeting.
The AMA will continue to staff the United States Adopted Names (USAN) Council, which assigns the generic names for the active ingredients in all drug products marketed in the United States (http://en.wikipedia.org/wiki/United_States_Adopted_Name). AMA cosponsors the USAN Council along with the US Pharmacopeia (USP) and the American Pharmacists Association (APhA). The FDA has a liaison member. USAN Council activities are supported by user fees from sponsors applying for names and from the sale of print and electronic data bases. Former APCR Board of Trustees member Judith Jones and I are the only two physicians among the five Council members. I was elected Chairman of the USAN Council in January 2012. Both of us have been reappointed to serve on the USAN Council through the end of 2015.
At the AMA, APCR is a member of the Section Council on Preventive Medicine (SCPM). Other SCPM members include the American Association of Public Health Physicians, the American Public Health Association, the American College of Preventive Medicine and the Aerospace Medical Association. Representative of the US military services, the US Public Health Service and the US Department of Veterans Affairs also attend our Section Council meetings.
Saul Levin, former AMA VP for Science and [Preventive] Medicine and former Interim Director of the District of Columbia Department of Health, has accepted a new position as Medical Director (Chief Executive Officer) of the American Psychiatric Association.
The AMA Delegation from MedChi – The Maryland State Medical Society provides me with important backup and logistic support at meetings of the AMA House of Delegates. I am a life member of MedChi and I have represented MedChi in the US Pharmacopeial Convention since 2008.
AMA is experiencing membership growth for the fourth straight year. Clinical research is becoming an increasingly important part of the AMA agenda.
Please feel free to call upon me if I can answer any questions.
Peter H. Rheinstein, M.D., J.D., M.S.
Severn Health Solutions
American Board of Legal Medicine
United States Adopted Names Council
AMA Delegate and Past President
Academy of Physicians in Clinical Research
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Severna Park, MD 21146-3520