The FDA is proposing a massive cut to its Office of Women’s Health (OWH), and Ruth Merkatz—director of the office from its inception to 1996—is flaming mad.

“This is very unfortunate; we just hate to see the books being balanced on the backs of women’s health,” said Merkatz, adding that the office has never seen a budget cut before. Its budget has only grown since its inception in 1994, when it was funded at $2 million.

Late last month, the FDA announced that it planned to cut the office’s budget from $4 million to $2.8 million in the middle of fiscal year ’07—after Congress had already allocated $4 million for the OWH for the fiscal year. Another $350,000 is slated to come out of next year’s budget.

New Research Not Funded?

If the cuts go into effect, the OWH will be hamstrung, said Merkatz, who called the cuts “draconian.”

“This cut comes in the middle of the fiscal year —they were unable to plan for it,” Merkatz said. “They had allocated all the funds and were in the middle of getting ready to do an allocation review of the grant proposals [for upcoming research]. So, that’s not going to happen.”

The office will, she thinks, be able to continue to fund current grantees and pay staff salaries, but that’s it. 

Payback From President?

Why the slashing now? No one is saying. But some, like the National Research Center for Women and Families, speculate that this may be payback from the Bush Administration. The OWH was at the center of the dragged-out, politically charged emergency-contraceptives debate, taking a position that upset conservatives. Things got so heated over that issue that Susan Wood, the office’s director during the controversy, resigned in protest in 2005.

The fear, said Merkatz—now director of clinical development, reproductive health, at The Population Council in New York—is that this may be the beginning of the end for the OWH, as the eventual demise of offices like this often begins with budget cuts. But heavyweight Democratic senators Hillary Clinton (New York), Patty Murray (Washington) and Barbara Mikulski (Maryland) as well as Republican Senator Olympia Snowe (Maine) are doing their best to make sure that doesn’t happen. Last week, Clinton wrote a letter to FDA Commissioner Andrew von Eschenbach urging him to reconsider the cuts, and the others signed on.

“Slashing funding for the OWH would … shortchange promising efforts to improve women’s health,” they wrote.

Von Eschenbach has said a final decision on the matter will be forthcoming by March 15.

OWH Opened Doors for Women In Trials

The OWH was originally spearheaded to do away with the ban on women’s participation in clinical trails. Its next focus was ensuring that the clinical data on women was properly analyzed so that scientists could have a better idea of how drugs worked in women vs. men. To this end, the OWH developed systems for tracking women’s participation in trails. Since then, the office has funded research into QT intervals and the interactions between prescription drugs and dietary supplements. It has also found itself at the center of several firestorms, including the one on breast implants. The office also sponsored the first-ever conference on drugs and pregnancy.

In addition to funding research, the OWH has a robust education arm, doing outreach into communities to educate women on things like what to do about hormone replacement, and what exactly is in the drugs they take. 

“We presented this type of information to women in a way that was not biased by the pharmaceutical industry,” Merkatz said. “There is no other center that’s going to do that.”

—by Suz Redfearn