Session: Drug Manufacturers, the FDA, and U.S. Health Care: How Can the Public Be Assured of Access to Safe, Effective Medicines?

APHA Scientific Session and Event Listing

4240.1: Tuesday, November 07, 2006: 2:30 PM-4:00 PM

Panel Discussion

Drug Manufacturers, the FDA, and U.S. Health Care: How Can the Public Be Assured of Access to Safe, Effective Medicines?

The public would like assurance that the medicines offered to it are safe, effective, and affordable. On all three counts, it is now widely believed that the public needs to look not only to the integrity of medical scientists and to the regulatory functions of the FDA but beyond these, to the influence of the pharmaceutical industry. The past decade has witnessed increasingly sharp criticism of that industry by both health professionals and the general public. The industry is widely seen not only as promoting development of groundbreaking new therapies but also as wielding its economic power to exert undue, self-serving influence over the scientific, legislative, and drug regulatory processes; the training of professionals; and the information flow among scientists, health professionals and the public. Further, it is seen as exploiting the patent system to the extent of pricing medicines beyond the reach of many who need them as well as straining government finances. Session design: A diverse panel will examine these criticisms and will give its views on the need for reforms. The panelists will make three-minute opening statements. The moderator will then pose a series of questions. As each question is posed, panelists will offer responses approximately a minute long.

Learning Objectives: At the conclusion of the session, the participant (learner) will be able to discuss: 1. The influence of the U.S. pharmaceutical industry on the regulatory and legislative processes to which the public looks for assurance that its medicines are safe and effective; on the flow of information among scientists, health professionals and the public; on the training of health professionals; and on the operation of the patent system to prolong monopoly pricing. 2. Reforms proposed.

Panelist(s):

John D. Abramson, MD
Marcia Angell, MD
David Graham, MD, MPH
Jerome P. Kassirer, MD
Deborah Socolar, MPH

Organizer(s):

Sidney J. Socolar, PhD
Julie M. Zito, PhD, MS

Moderator(s):

Merrill Goozner, MA

2:30 PM

Drug Manufacturers, the FDA, and U.S. Health Care: How Can the Public Be Assured of Access to Safe, Effective Medicines?

See individual abstracts for presenting author's disclosure statement and author's information.

Organized by:

Medical Care

Endorsed by:

APHA-Committee on Women's Rights; Epidemiology; Socialist Caucus; Vietnam Caucus

The 134th Annual Meeting & Exposition (November 4-8, 2006) of APHA