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

Abstract #120486

Robert P. Eilers, MD, MPH, New Jersey Division of Mental Health Services, Capital Center, 50 East State St., P.O. 727, Trenton, NJ 08625, 609/777-0686, robert.eilers@dhs.state.nj.us

In the wake of recent safety concerns involving Vioxx, many have been asking why the FDA took so long to act on available information about its potential risks. Yet, this drug is only one of many heavily marketed 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, including on Direct-to-Consumer (DTC) advertisements, insure that millions of people will be exposed to their risks before their removal. Some critics have noted that increasing numbers of these recalls and re-labeling of drugs have occurred since changes were made to speed up the drug approval process and make the FDA more dependant on industry for its funding. Others have criticized the agency's use of expert advisory panels that have close ties to the pharmaceutical industry. Congress has proposed that there be increased disclosure in the form of a drug trial registry and reforms that reduce conflicts of interest and insure that those involved with drug safety have more independence from industry. Others have highlighted the need for more evidence-based drug information from independent experts, and the need for more postmarketing studies, including head to head drug trials to determine comparable effectiveness and also cost-effectiveness. The session will examine these initiatives and proposals, as well as the need for better educated consumers who can advocate for safe and effective pharmaceuticals.

Learning Objectives: At the conclusion of the session, participants will be able to

• recognize the many safety concerns associated with prescription drugs.
• evaluate the impact of various policy initiatives that could improve what is known about the safety risks of prescription drugs, both before and after these are marketed.
• assess the roles of the government, drug industry, health care providers, and consumers in ensuring the safe and effective use of drugs.

Keywords: Drug Safety, FDA

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.