FDA DISCUSSING EDUCATION PROGRAM TO BALANCE DRUG PROMOS; JUNE 12 MEETING WITH THREE MEDICAL GROUPS INAUGURATES EFFORT TO WORK WITH ORGANIZED MEDICINE
FDA is exploring a role in medical education courses to balance commercial promotions. According to an account of a recent meeting between a large FDA contingent and the representatives of three medical societies, the agency is willing to work with organized medicine to develop courses to help doctors deal with promotional materials. FDA invited representatives of the American Medical Association, the American College of Physicians and the American College of Cardiology to FDA headquarters on June 12 "to explore ways in which FDA and organized medicine can work together to eliminate inappropriate influences on prescribing behavior" (see box below for a list of attendees). The joint sponsorship or collaboration on education projects was one suggestion specifically raised by FDA. The agency's minutes of the June 12 meeting defined one "possible area(s) of cooperation" as a project to develop "a teaching module or a series of modules that could be directed at physicians, from the pre-medical student through to the practicing physician." The use of government-designed courses to make physicians more aware of commercial messages and information has been suggested in the past by critics of the current promotional climate. Two witnesses at Sen. Kennedy's (D-Mass.) promotion hearings last December urged that approach. Health Research Group Director Sidney Wolfe, MD, suggested during a question and answer exchange with Sen. Hatch (R-Utah) that FDA should begin a pilot program to test the effect of specific medical school courses designed to balance promotional techniques. Similarly, an assistant professor of medicine from the University of Minnesota, Nicole Lurie, MD, noted that some medical schools have developed courses to teach students how to evaluate medical literature more critically. The responses of the medical groups at the June 12 meeting is not recorded by FDA in its account of the meeting. However, the agency is presumably fully aware that organized medicine is very interested in maintaining the current level of continuing education programs in the U.S. The three groups were selected for the June 12 meeting because of their previous activity in the area of promotions and ethical guidelines. In addition to their general ethical guidelines issued last December, AMA participated in a group which developed recently-released guidelines on CME programs. On May 1, the Accreditation Council for Continuing Medical Education adopted that effort under the title, "Guidelines for the Continuing Support of Continuing Medical Education" ("The Pink Sheet" April 15, T&G-1). AMA is reportedly scheduling a follow-up meeting on the CME topic for early this autumn. The American Academy of Family Physicians is understood recently to have held a similar session on the subject of the funding of CME programs. AMA also has taken an active role in establishing its own series of medical symposia, the most recent of which was on dystonia (supported by a grant from Allergan). AMA has handled three symposia thus far in 1991 and has two more scheduled. The organization says that it has established "strict editorial control" over its seminars, by writing the agenda and choosing speakers, and by working with individual speakers on presentations. A spokesperson for AMA said "we make sure there is a balance in . . . what is talked about." The June 12 meeting is noteworthy as Commissioner Kessler's first attempt to contact FDA's medical constituency after the initiation of his aggressive campaigns against drug promotions. It is also interesting for its timing: one day after his testimony on Capitol Hill at Rep. Weiss' (D-N.Y.) hearing on Retin-A, collagen treatments and breast implants. At that hearing, Kessler delivered a direct, stern warning to MDs participating in the promotion of unapproved uses of medical products. At the June 12 meeting, FDA also reported suggesting participation with organized medicine on the promotion "hotline." FDA asked the medical groups to consider helping in the development of "a telephone service for physicians to discuss questions about pharmaceutical promotion." The agency is in the process of establishing a promotion abuse telephone "hotline" for physicians and pharmacists ("The Pink Sheet" April 29, p. 3). FDA's JUNE 12 MEETING WITH MEDICAL GROUPS (BRACKET)Reproduced from an FDA memorandum(BRACKET) American College of Physicians Frank Davidoff, associate exec VP-education Howard Shapiro, acting director, public policy American College of Cardiology William Nelligan, exec VP Sylvan Weinberg, VP American Medical Association Roy Schwarz, VP-medical education & scientific policy Kirk Johnson, general counsel Dennis Wentz, director, continuing medical education David Orentlicher, ethics & health policy counsel FDA David Kessler, commissioner Stuart Nightingale, associate commissioner for health affairs Carol Kimbrough, special assistant to the associate commissioner, Office of Health Affairs Peter Rheinstein, director, medicine staff, OHA David Adams, Office of General Counsel Ann Witt, acting director, Division of Drug Marketing, Advertising & Communications, CDER Louis Morris, Division of Drug Marketing, Advertising & Communications, CDER Sharon Risso, CBER Steven Niedelman, deputy director, Division of Compliance Operations, CDRH Mary Doug Tyson, CDER Jerome Donlon, director, Office of Biological Product Review, CBER Betty Palsgrove, medicine staff, OHA Bonnie Lee, executive secretariat
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth