157931 Women's health and the FDA: Buffeted by political battles

Wednesday, November 7, 2007: 1:10 PM

Cynthia A. Pearson , National Women's Health Network, Washington, DC
Amy Allina , National Women's Health Network, Washington, DC
Since its inception, the Food and Drug Administration (FDA), the U.S. government's main watchdog agency over the pharmaceutical industry, has been subject to political pressures that undermine its mission to ensure drug safety and protect consumer health. In the last several years, these pressures have intensified as the FDA is buffeted by the Bush administration's right-wing agenda and an ever more powerful pharmaceutical industry. More often than not, women's reproductive health and safety are caught in the crossfire of these political and economic agendas. Since the FDA was first created early in the twentieth century, there have been struggles between businesses, determined to fight off government interference, and consumers and their advocates, working to establish a role for the federal government in protecting the public health. The FDA Modernization Act of 1997 reshaped the agency in response to the drug industry's long-held desires. The new law speeded up drug approvals, scaling back safety requirements, and even redefined the agency's mission statement to commit it to working in consultation with “manufacturers, importers, packers, distributors, and retailers of regulated products.” Patient activists have sometimes made common cause with industry, pushing for faster drug approvals even at the expense of rigorous safety testing. When it comes to contraception, the political battles sometimes converge, subjecting these critical women's health products to the complicated tensions of the safety/access balance as well as the bruising assaults of the anti-choice, anti-family planning right-wing.

Learning Objectives:
1. Evaluate current proposals for reforming the FDA and their potential impact on women's health. 2. Identify controversial women's health decisions made by FDA. 3. Describe competing pressures faced by FDA and the impact on FDA's science-based decision-making process.

Keywords: Women's Health, Family Planning

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.