AMA Delegate's Report

Once again it was my honor to represent APCR at meeting of the American Medical Association (AMA) House of Delegates. The Interim Meeting was held in at the Hawaii Convention Center in Honolulu from November 9 through November 13.

This was my second meeting with a badge labeled with our new name, Academy of Physicians in Clinical Research (APCR). The new name continues to draw favorable comments. (It also puts us first in the alphabetical list of medical specialties represented in the AMA House of Delegates.)

EXECUTIVE SUMMARY

Issues relevant to physicians in clinical research included Council on Science and Public Health (CSAPH) reports on Use of Atypical Antipsychotics in Pediatric Patients, Risk Evaluation and Mitigation Strategies (the FDA REMS program), and clinical applications of next generation genome sequencing. CSAPH also updated its June 2012 report on drug shortages. AMA Executive Vice President Jim Madara described progress on AMA’s five-year strategic plan and reported that AMA membership increased by 1% in 2011 and 3% thus far in 2012. The House of Delegates adopted a Board of Trustees report making it easier for specialty societies such as APCR to qualify for delegate status. The House adopted resolutions supporting federal budget allocations for Prevention and Public Health; standardized labeling of prescription containers; better regulation of pharmaceutical compounding; and opposition to “Pay for Delay” of generics. The Council on Medical Service was asked to address how specialty medications would be treated in formulating a value-based insurance design to ensure that these drugs are affordable for patients who need them. As of today, the complete meeting website is at www.ama-assn.org/go/interim2012. 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.

ATYPICAL ANTIPSYCHOTICS

The House adopted CSAPH Report 1 making it AMA policy to urge the National Institute of Mental Health to assist in developing guidance for physicians on the use of atypical antipsychotic drugs in pediatric patients and (2) encourage and support ongoing federally funded research, with a focus on long term efficacy and safety studies, on the use of antipsychotic medication in the pediatric population.

RISK EVALUATION AND MITIGATION STRATEGIES

The House adopted CSAPH Report 3, but added two additional recommendations. Paragraphs 1, 3, 4, and 5 of the new policy were recommendations of the original report. Paragraphs 2 and 6 reflect concerns voiced in the reference committee hearing that REMS need to be evidence-based and should reflect input from practicing physicians:

1. The Food and Drug Administration (FDA) issue a final industry guidance on Risk Evaluation and Mitigation Strategies (REMS) with provisions that: (a) urge require sponsors to consult with impacted physician groups and other key stakeholders early in the process when developing REMS with elements to assure safe use (ETASU); (b) establish a process to allow for physician feedback regarding emerging issues with REMS requirements; and (c) recommend clearly specify that sponsors must assess the impact of ETASU on patient access and clinical practice, particularly in underserved areas or for patients with serious and life threatening conditions, and to make such assessments publicly available; and (d) conduct a long-term assessment of the prescribing patterns of drugs with REMS requirements.
2. The FDA, in concert with the pharmaceutical industry, evaluate the evidence for the overall effectiveness of REMS with ETASU in promoting the safe use of medications and appropriate prescribing behavior.
3. FDA ensure appropriate Advisory Committee review of proposed REMS with ETASU before they are finalized as part of the premarket review of New Drug Applications, and that the Drug Safety and Risk Management Advisory Committee fulfills this obligation for drugs that are already on the market and subject to REMS because of new safety information.
4. To the extent practicable, a process is established whereby the FDA and sponsors work toward standardizing procedures for certification and enrollment in REMS programs, and the common definitions and procedures for centralizing and standardizing REMS that rely on ETASU are developed.
5. REMS-related documents intended for patients (e.g., Medication Guides, acknowledgment/consent forms) be tested for comprehension and be provided at the appropriate patient literacy level in a culturally competent manner.
6. The FDA solicit input from the physician community before establishing any REMS programs that require prescriber training in order to ensure that such training is necessary and meaningful, requirements are streamlined and administrative burdens are reduced.

NEXT-GENERATION SEQUENCING

The House adopted CSAPH Report 3, but added the second recommendation regarding development of standards as well as the verbiage regarding patient rights in Paragraph 4:

1. Our American Medical Association recognizes the utility of next-generation sequencing (NGS)-based technologies as tools to assist in diagnosis, prognosis, and management, and acknowledges their potential to improve health outcomes. (New HOD Policy)
2. Our American Medical Association encourages the development of standards for appropriate clinical use of NGS-based technologies and best practices for laboratories performing such tests. (New HOD Policy)
3. Our American Medical Association will monitor research on and implementation of NGS based technologies in clinical care, and will work to inform and educate physicians and physicians-in-training on the clinical uses of such technologies. (Directive to Take Action)
4. Our American Medical Association will support regulatory policy that protects patient rights and confidentiality, and enables physicians to access and use diagnostic tools, such as NGS-based technologies, that they believe are clinically appropriate. (New HOD Policy)
5. Our American Medical Association will continue to enhance its process for development of CPT codes for evolving molecular diagnostic services, such as those that are based on NGS; serve as a convener of stakeholders; and maintain its transparent, independent, and evidence-based process. (Directive to Take Action)

At the meeting, AMA also sponsored a CME session on next-generating sequencing. I will supplement the report with the presenters’ slides if they are made available.

AMA EXECUTIVE VICE-PRESIDENT’S REPORT

Dr. Madara updated the House of Delegates on AMA's five-year strategic plan. The AMA's plan focuses on three areas that are critical for building a health care system that enables sustainable practices and better health outcomes. These areas are:

• Improving health outcomes for patients in ways that add value.
• Accelerating change in medical education to align physician training and education with the future needs of the health care system.
• Enhancing professional satisfaction and practice sustainability by helping physicians navigate delivery and payment models.

Dr. Madara’s speech is available on YouTube here.

DRUG SHORTAGES

AMA policy already lays out an extensive series of recommendations that position the AMA to be actively engaged in efforts to identify problems and issues that contribute to medication shortages, as well as the mitigation of such shortages. The updated report adopted by the House at this meeting adds that AMA will collaborate with medical specialty partners in identifying and supporting legislative remedies (previously, “Urges Congress to amend the 2003 Medicare Modernization Act”) to allow for more reasonable and sustainable payment rates for prescription drugs.

REVISED REQUIREMENTS FOR HOD REPRESENTATION

A specialty organization must demonstrate that it has a minimum of 100 (down from 250) AMA members and that 20% (down from 25%) of its physician members who are eligible for AMA membership are members of the AMA. Specialty societies are reviewed for compliance with these minimums every five years. APCR’s next required recertification will be in 2017.

SUPPORT FOR PREVENTION AND PUBLIC HEALTH FUND DOLLARS

The House adopted policy that AMA supports budget allocations for the Prevention and Public Health Fund at no less than the levels adopted in the Affordable Care Act of 2010 (New HOD Policy); and that AMA actively oppose policies that aim to cut, divert, or use as an offset, dollars from the Prevention and Public Health Fund for purposes other than those stipulated in the Affordable Care Act of 2010. (Directive to Take Action) Adoption of this wording was a victory for the Section Council on Preventive Medicine over arguments that support of this budgetary objective might be seen as undercutting support for funding necessary for ending the sustainable growth rate formula for physician reimbursement under Medicare.

PHARMACEUTICAL COMPOUNDING

A resolution on compounding reflected concern about compounding based on recent news stories. The House adopted policy that AMA: (1) monitor ongoing federal and state evaluations and investigations of the practices of compounding pharmacies; (2) encourage the development of regulations that ensure safe compounding practices that meet patient and physician needs; and, (3) report back on efforts to establish the necessary and appropriate regulatory oversight of compounding pharmacy practices. (Directive to Take Action)

PAY FOR DELAY

The House adopted a resolution to put AMA on record as supporting federal legislation that makes tactics delaying conversion of medications to generic status, also known as “pay for delay,” illegal in the United States. (New HOD Policy)

Numerous delegates testified in support of this resolution and the Reference Committee agreed that incentives are needed to promote new drug treatments, but anti-competitive agreements between brand drug companies and certain generic companies to delay the entry of other generic competitors beyond the market exclusivity period envisioned by Congress is extraordinarily costly to patients and reduces their access to important medications.

STANDARDIZED PRESCRIPTION LABELING

The House approved Policy that AMA encourage state Boards of Pharmacy to adopt the newly revised standards contained in the United States Pharmacopeia general chapter on prescription container labeling, which offers specific guidance on how prescription labels should be organized in a patient-centered manner. (Directive to Take Action) A part of the resolution asking that prescriptions be labeled with the purpose of the medication was defeated.

COST OF SPECIALTY DRUGS

Council on Medical Service Report 1 provided background on the use and insurance treatment of specialty drugs. Testimony on the report expressed concern that the recommendations did not go far enough in identifying ways to ensure that high cost specialty drugs remain affordable for those who need them. The House requested that the Council specifically address how specialty medications would be treated in a value-based insurance design to ensure that these drugs are affordable for patients who need them. The Council report on value-based insurance design is scheduled for AMA’s June 2013 meeting.

PERSONAL NOTES

The AMA will continue to staff the United States Adopted Names (USAN) Council, which assigns the generic names for all drug products marketed in the United States. 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. I was elected Chairman of the USAN Council in January 2012. Both former APCR Board of Trustees member Judith Jones and I have been reappointed to serve on the USAN Council through the end of 2013.

At the AMA, APCR is a member of the Section Council on Preventive Medicine (SCPM). AMA EVP Jim Madara, as well as Modena Wilson, AMA Senior VP for Professionals Standards: Al Osbahr, former Member of SCPM and current AMA Trustee; and Barry Dickinson, AMA Director of Science and Biotechnology & Secretary of CSAPH, stopped by an SCPM meeting to reassure the Section Council that Public Health is still a priority for AMA. The Section Council had expressed these concerns in a letter to Dr. Madara following the June 2012 annual meeting. I mentioned to Dr. Madara that the USAN Council remains responsible for more than 50% of all applications for International Nonproprietary Names (INN) presented to the World Health Organization, that this number reflects the success of American clinical research, and presents a powerful argument for continued funding of research. Dr. Madara responded that he feels the current level of US research expenditures (about $100B for government and industry combined out of a $2.7T budget) is about right.

Saul Levin, former VP for Science and [Preventive] Medicine, has accepted a new position as Interim Director of the District of Columbia Department of Health. He has also returned to the House as a Delegate from the American Psychiatric Association.

I was honored to serve as Chief Teller for the 2012 Interim meeting. The Speakers have also appointed me to serve in this role for the 2013 Annual meeting. (The Chief Teller is responsible for AMA elections.)

AMA discontinued providing staff support for the National Task Force on CME Provider/Industry Collaboration effective October 31, 2012 following the annual conference in Baltimore. The Alliance for Continuing Medical Education has expressed an interest in integrating Task Force activities into its programs. I have been a member of the Task Force since 1992.

CONCLUSION

AMA is experiencing membership growth for the second straight year. In light of the Supreme Court decision upholding the Patient Protection and Affordable Care Act, AMA’s focus on three major initiatives (patient outcomes, medical education, and physician practice sustainability) will give organized medicine a leadership role in shaping the future of medicine and clinical research.

Please feel free to contact me if I can answer any questions.

Thanks,
Peter H. Rheinstein, MD, JD, MS