While we are on the subject of emergencies . . .

Harvard’s World Health News arrived by email yesterday (9-15-05) with an article about how the health ministry in India has made emergency contraceptive pills available to women in India without a prescription. According to The Times of India (September 9, 2005), Health Minister Ramadoss noted that “More than 100 countries have made ECPs an OTC drug. China is making it available through vending machines. This is our way to help empower women in India.'"

This caused me to refocus on the fact that American women have been once again denied such empowerment. And I am not alone. As Amy Goodman says today in the Boston Globe,

NOW that we have waved "Bye, Bye, Brownie" to Michael Brown, the hapless head of FEMA, could we turn our sights back to another agency on the skids: the Food and Drug Administration? If FEMA is an example of a government run on cronyism, the FDA has become a portrait of a government run on ideology. After its blunders over Vioxx and defective heart devices, it has now deliberately tanked the homeland emergency contraceptives.

On August 26 the FDA deferred ruling on over-the-counter sales of Barr Pharmaceuticals Inc.'s "morning-after" contraceptive on the grounds that approving the contraceptive for women over 17 would risk enabling girls under 17 access the contraceptive. When FDA denied approval in 2004 it was because of objections related to access by young teens.

Meanwhile Republican politicians are scoring points with the national Republican party and conservative voters by vetoing emergency contraception legislation with wide state support. In July Governor Mitt Romney (MA) vetoed state legislation to expand access to emergency contraception. This week the Massachusetts Senate overrode his veto 37-0. The House had already overridden the veto 139-16. In his 2002 campaign, Romney said he supported wider access to emergency contraception. I guess things change the closer he gets to thinking about national office. (New York Times, September 16, 2005)

In early August, Pataki did the same thing in New York State, vetoing the emergency contraception bill on the grounds that it would allow minors access to contraception without seeing a doctor.

Democracy Now notes that vetoing emergency contraception legislation is a trend among presidential hopefuls.

Meanwhile, overshadowed by Katrina and the recognition, finally, by millions of Americans that this administration will not—cannot—keep them safe from disaster of any kind, was the rare principled action of Susan Woods, Director of FDA’s Office of Women’s Health, who resigned over the FDA decision to delay yet again approval of Plan B emergency contraceptive. A group of women’s health advocacy organizations wrote this powerful statement in response to Woods’ resignation.

August 31, 2005

Washington, DC - The national effort to improve the health of women suffered a serious blow today with the resignation of Dr. Susan F. Wood as the director of the FDA's Office of Women's Health. Dr. Wood resigned in protest over the agency's handling of Plan B. She announced her resignation earlier today.

The women's health community applauds Dr. Wood for her personal commitment to the FDA's mission of making science-based decisions to improve the health of the public and we are very sorry to lose her. Dr. Wood was one of the champions of a decade-long effort to improve women's health through increased federal research and support.

Dr. Wood's impact on women's health was felt in many ways during her nearly 5 years at the FDA. She led the agency's effort to ensure that women were included in trials of new drugs and medical devices, and put into place reporting and recordkeeping systems that enabled researchers to quickly determine whether women were affected differently than men by specific products.

Dr. Wood was also a key player in the FDA's efforts to increase our shared knowledge about the effects of medications used in pregnancy on the health of the fetus and the pregnant woman.

Dr. Wood also demonstrated her leadership in women's health by creating new programs to communicate important health information to average women, such as the FDA's Take Time to Care campaign. She was awarded the Commissioner's Certificate of Excellence for her work on the agency's education campaign on menopause hormone therapy.

Dr. Wood encouraged dialogue with the FDA on a broad range of women's health issues, from many avenues. She welcomed input from consumers as well as industry, health professionals and biomedical researchers.

The resignation of Dr. Wood is just one example of the damaging implications of the FDA's willingness to ignore clear scientific evidence and clear scientific shortcomings in their approval decisions for prescription drugs, medical devices, and other medical products. American women will be harmed directly by FDA's inappropriate decisions, as well as indirectly harmed when outstanding public servants decide to resign from this ailing agency.

Lorraine Cole, President
Black Women's Health Imperative
(202) 548-4000

Barbara Brenner, Executive Director
Breast Cancer Action
(415) 243-9301

Cindy Pearson, Executive Director
National Women's Health Network
(202) 347-1140

Judy Norsigian, Executive Director
Our Bodies, Ourselves
(617) 233-0062

Diana Zuckerman, President
National Research Center for Women &
Families
(202) 223-4000