Session: After Vioxx: Whither Drug Safety in the U.S (Medical Care Section Solicited Session #4)


Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

5059.0: Wednesday, December 14, 2005: 8:30 AM-10:00 AM

Oral

After Vioxx: Whither Drug Safety in the U.S (Medical Care Section Solicited Session #4)

In the wake of recent safety concerns involving Vioxx, many have asked why the FDA took so long to act on information about its potential risks. Yet, this drug is only one of many drugs that had to be removed from the market or had safety concerns come to light after initial approval. The vast amounts spent on marketing of these drugs, mostly on Direct-to-Consumer (DTC) advertisements, had led to many millions of people being exposed to their risks before their removal. Increasing numbers of such recalls and re-labeling of drugs have occurred since legislation was enacted to speed up the drug approval process in the 1990''s. TYoday, the FDA has become more dependant on the industry for its funding, and its expert advisory panels have close ties to the pharmaceutical industry. Congress has proposed that there be increased disclosure in the form of a drug trial registry and has called for reforms that strengthen the FDA conflict of interest rules and that insure more independence from industry. Clearly, more evidence-based drug information from independent experts is needed. Reform efforts should require more postmarketing studies, including head to head drug trials to determine comparable effectiveness and also cost-effectiveness.

Learning Objectives: 1. Afer the presentation, participants will recognize the need for drugs that are safe and effective. 2. After the presenattion, participants will understand the need for reform of the drug approval process and ethe ways to improve it.

Organizer(s):

Robert P. Eilers, MD, MPH

Presider(s):

Robert P. Eilers, MD, MPH

8:30 AM

Committee on the Assessment of the US Drug Safety System