FDA funding cuts threaten to undermine women’s health

Newswise — The Society for Women’s Health Research has learned that administrators within the U.S. Food and Drug Administration want to cut the budget of the agency’s Office of Women’s Health by $1.2 million for the current fiscal year.  This cut goes against presidential and congressional requests and would cripple the office, forcing it to stop all programmatic operations for the rest of the year.

The FDA Office of Women’s Health (OWH) works to protect and advance the health of women through policy, science and outreach.  It also advocates for the inclusion of women in clinical trials and the analysis of research data for sex, gender and subpopulation differences.

“We fear this is the first step in the complete elimination of the FDA Office of Women’s Health,” said Phyllis Greenberger, M.S.W., president and CEO of the Society for Women’s Health Research, a Washington, D.C., based advocacy organization, who received the information from sources close to the FDA.  “OWH is a vital and necessary focal point for women’s health at FDA.  It was created in 1994, when women’s health received little or no attention from the agency.  The mission of OWH is not complete and we must not allow it to be eliminated or reduced to an empty shell that has no program funding.”

The president and Congress intend for OWH to be funded at $4 million annually.  This was the amount approved for 2006 and was in the budget for 2007.  The expected cut represents roughly half of the OWH program budget, which goes toward research grants and outreach activities, both of which are tasks Congress specifically asks OWH to perform.

“The expected cut will slash the OWH program budget in half,” Greenberger said.  “If it takes place, OWH has already spent or committed more money than it will have for the entire year.  We are almost half way into the fiscal year, so OWH will have no choice but to shut down all of its programmatic operations for the rest of the year.”

FDA leaders believe the agency’s various centers, such as the Center for Drug Evaluation and Research, are capable of addressing women’s health issues without the work or support of an OWH located within the Office of the Commissioner, but Greenberger says that’s not the case.

“The Office of Women’s Health was established because the FDA was not adequately addressing women’s health,” Greenberger said.  “The FDA centers have made progress – thanks to the efforts of OWH – but much work remains to be done.  The centers do not have enough funding to perform their own duties, much less take on additional responsibilities related to women’s health.

“OWH fully exhausts its tiny budget each year.  A cut of this magnitude will undermine advances that have been made in women’s health and disregard the reasons why OWH was created.”

Why is the Office of Women’s Health Research under attack?

“The reasons are unclear,” Greenberger said, “but three possibilities must be considered.  First, this may be retaliation against OWH for sticking its neck out over women’s health issues over the last several years.  Second, FDA leaders apparently do not recognize the value of a strong, central women’s health advocate within its own agency, despite historical inequities.  Third, FDA leaders erroneously believe its various centers can fully address women’s health needs on their own, something they have not demonstrated.”

Andrew C. von Eschenbach, M.D., commissioner of the FDA, will testify before Congress on Tuesday and Wednesday. 

“It is imperative that Dr. Eschenbach address this issue before Congress when his budget is reviewed,” Greenberger said.  “We need assurances that OWH will be fully funded in 2007 as intended by the president and Congress.”

The assault on OWH is not limited to 2007.  The president’s proposed budget for 2008 cuts OWH by $350,000.

“Future cuts will severely hamper OWH’s ability to perform its functions,” Greenberger said.  “But our chief concern today is that OWH may cease to exist in the near future if a $1.2 million cut takes place this year.  We must not allow this important office within FDA be eliminated or marginalized.”