Battle-Ready DeLauro Flexes New Muscle on FDA

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Rep. Rosa DeLauro

WASHINGTON (WOMENSENEWS)–The House Appropriations Subcommittee on Agriculture is known more as a coveted assignment for farm-state lawmakers than a bastion for women’s rights leaders.

But that is what it is becoming under the control of Rep. Rosa DeLauro, a Connecticut Democrat who is one of only three female House lawmakers known on Capitol Hill as a “cardinal,” or one of the chairs of the 12 appropriations subcommittees that dole out federal dollars.

As the first woman to run the powerful subcommittee, DeLauro has done steady battle against actions affecting women’s health by the Food and Drug Administration, a Rockville, Md., agency of the executive branch that falls under the subcommittee’s jurisdiction.

The panel determines how much money the federal government spends on the FDA and can direct funding to or against specific programs. As chair, DeLauro can also call oversight hearings and compel testimony on subjects of her choice.

DeLauro joined the political protests against controversial FDA moves affecting women in the first term of the Bush administration. But she is now using her newfound clout to push back harder than ever.

Bill Emphasizes Women’s Health

In her most recent move, DeLauro in May introduced the Scientific Fairness Act for Women, which she portrayed as a way of blocking the FDA from making decisions that put corporate or ideological interests above the interests of women’s health.

FDA spokesperson Karen Riley disputed that claim, saying the agency makes its decisions based on scientific data available in product submissions. “Ultimately it comes down to a finding of whether the product is safe and effective,” she said.

The immediate prospects for the measure are unclear: It currently awaits action in a House committee, and there is no companion legislation in the Senate yet.

The bill would ban silicone breast implants until scientific studies prove their long-term safety; require the FDA to study scientific data on the use of emergency contraception by women under 18; and make the FDA’s Office on Women’s Health a funding priority.

“When the FDA reviews drug and medical device applications, the American people expect the FDA to be objective and independent, making decisions based on science, not on corporate and political considerations,” DeLauro said in a statement. “Unfortunately, recent actions suggest that no one has more at stake in de-politicizing FDA decisions and restoring integrity to the agency than women, which is why we need to prioritize women’s health at the agency and ensure scientists are able to work unfettered.”

Riley declined to comment on DeLauro’s bill.

DeLauro’s dark references to “recent actions” that spurred the bill refers to a timeline that begins about a year ago, when the FDA in August 2006 made a long-delayed decision to allow over-the-counter sales of emergency contraception to women 18 and older but not to younger women, often those who need it the most.

In announcing the decision, which had been put on hold since 2003, FDA Commissioner Andrew von Eschenbach overruled the recommendations of the FDA’s own advisory panel, which had recommended nonprescription sales of the drug, known as Plan B, to women of all ages.

Emergency Contraception Pressures

During the delay, reproductive rights advocates accused the FDA of bowing to political pressure from some religious activists who view emergency contraception as an abortifacient because it can prevent a fertilized egg from implanting in the uterus. The Washington-based American College of Obstetricians and Gynecologists, says the drug prevents and does not end pregnancy, which occurs at the moment of implantation.

The delay prompted Susan Wood, former director of the FDA’s Office on Women’s Health, to resign in 2005. “I left the FDA truly with a heavy heart,” Wood recalled at a recent panel discussion on contraception in Washington. She said disregard for women’s health at the agency left her feeling quite depressed and concerned.

The next provocation occurred last November, when the FDA ended a 14-year ban on the cosmetic use of silicone gel-filled breast implants and allowed the sale of the implants to all women for reconstruction and to women 22 and older for augmentation. Critics say the health consequences of the implants are not fully known and have aired concerns about risks for women if the implants rupture or leak inside the breast.

The FDA’s Riley said the decision was based on extensive “pre-market data” that showed the implants to be safe and effective and noted that the FDA has mandated a 10-year post-approval study of the device.

But Kim Gandy, president of the National Organization for Women in Washington, D.C., has cited concerns over reports of high levels of toxic platinum salts from silicone. “More research is critically needed to determine what role these toxic platinum salts may play in making some women and their children very sick,” she said in a statement at the time.

During these developments in 2006, protests by activists and pro-rights politicians produced mixed results. They failed to block approval of silicone implants, but they won a partial victory by forcing the FDA to stop stalling on the decision to grant emergency contraception over-the-counter status. Although they failed to win access to all women, women over 18 now can get the drug without a prescription.

Push Toward Victory

Now, with DeLauro’s ascension to the helm of “Ag-Approps,” as the subcommittee is known, activists are hoping for more resounding victories.

Earlier this year, just weeks after DeLauro took over the subcommittee, word leaked that von Eschenbach intended to slash funding for the FDA’s Office of Women’s Health, which subsidizes research on the effects of pharmaceuticals on women and provides information on topics such as menopause, pregnancy, birth control and osteoperosis.

In February, media outlets reported that von Eschenbach intended to redirect $1.2 million of the office’s budget and use the money for other programs. The plan would have meant that the office would see a 30 percent cut in its $4 million budget, which advocates said would have forced it to suspend activities for the rest of the year.

DeLauro and other lawmakers and activists cried foul, and von Eschenbach backed down and announced he would continue funding the office at existing levels. In what turned out to be an insurance policy against future reversal, DeLauro also inserted a provision in an emergency supplemental spending provision securing $4 million in funding for the FDA’s women’s health office.

“It is very gratifying that the FDA reversed course and chose to fully fund the Office of Women’s Health at $4 million for fiscal year 2007,” DeLauro said in a statement at the time. “It took a great deal of pressure from a number of directions to successfully prevent the FDA from underfunding and dismantling the Office of Women’s Health.”

Women’s rights activists, meanwhile, say it’s gratifying to have DeLauro in her new post.

“It’s very important to have somebody like Rosa DeLauro there,” said Diana Zuckerman, president of the National Research Center for Women and Families in Washington, D.C. “It means we have somebody who can have more of an impact when decisions aren’t being made based on science.”

Allison Stevens is Washington bureau chief at Women’s eNews.

Women’s eNews welcomes your comments. E-mail us at editors@womensenews.org.

For more information:

“GAO Says Plan-B Politics Trumped Science at FDA”
http://www.womensenews.org/article.cfm/dyn/aid/2526/

Food and Drug Administration:
http://www.fda.gov

Rep. Rosa DeLauro:
http://www.house.gov/delauro/

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