R.E.S.P.E.C.T.: What Women Need From the New FDA Commissioner

Taken from the March/April 2017 issue of the Women’s Health Activist Newsletter.

After a long day of trying to figure out how to influence brand-new administration offices, write a compelling op ed, read the latest study on menopause, raise more money to help Raising Women’s Voices regional coordinators defend the Affordable Care Act, Aretha’s full-throated demand that the person important to her treat her with respect is just what I need.

Aretha’s insistence has been on my mind a lot lately. Why? In addition to all the other things I and the NWHN staff and interns are working on, we’re constantly trying to find out anything we can about who President Trump might choose as the next head of the Food and Drug Administration (FDA). Why are we so concerned about the FDA Commissioner? After all, President Trump promised that, “I’m pro-life. The judges [I appoint] will be pro-life,” and picked a Federal judge who seems to fit the bill. President Trump promised to repeal the Affordable Care Act (ACA) and picked someone to lead the Department of Health and Human Services who not only opposes the ACA, but also believes that women don’t need contraceptives to be covered by their insurance. And, President Trump picked someone to head the Centers for Medicaid and Medicare Services (CMS) who has helped two governors make it harder for people to use Medicaid. With Neil Gorsuch, Tom Price, and Seema Verma already facing us, how can we be worried about the FDA Commissioner?

Here’s a few things that FDA Commissioners have either done directly or allowed their senior staff to do:

  1. Overrode recommendations from two FDA advisory committees and prevented Emergency Contraceptive pills from going over-the-counter. (2004, President George W. Bush, acting Commissioner Crawford).
  2. Appointed physician Joseph B. Stanford to the advisory committee overseeing contraception despite his belief that all contraception is spiritually and physically harmful. (2002, President George W. Bush, Commissioner McClellan).
  3. Approved mifepristone with unnecessary restrictions on its distribution, and maintained those restrictions despite overwhelming evidence of its safety. (2000, President Clinton, Commissioner Henney; and 2016, President Obama, Commissioner Califf).
  4. Allowed staff to approve eteplirsen to treat muscular dystrophy, despite evidence that it didn’t produce clinical improvement (2016, President Obama, Commissioner Califf).
  5. Approved flibanserin despite the drug sponsor’s failure to complete the required study of drug/alcohol interaction in women. (2015, President Obama, acting Commissioner Ostroff).

It’s an interesting list, isn’t it? Some of the problematic actions taken by FDA Commissioners are clearly connected to the anti-abortion, anti-contraception ideology of the president. Other actions were not necessarily connected to the president’s views, but were, instead, the result of intense pressure brought by industry and industry-funded patient groups. And, sometimes the Commissioners are just timid (I’m thinking of #3.)

In all of these cases, though, women and their families would have been better-served if the FDA had treated them with respect. Respect for the ability of people who are sexually active to make their own good decisions about contraception and abortion. Respect for consumers who deserve medications that actually do what they are marketed to do. Respect for the importance of strong safety and effectiveness standards. Respect.

President Trump didn’t choose Aretha Franklin to sing at his inauguration. But I bet he knows the lyrics to her anthem. Can you hear us, Mr. President? We want an FDA Commissioner who knows the importance of r..e..s..p..e..c..t!

Cindy Pearson was the NWHN’s Executive Director from 1996 to 2021. One of the nation's leading advocates for women's health, Cindy often testified before Congress,  NIH and the FDA and was frequently featured in the news as a consumer expert on women’s health issues. When she retired, Cindy received a Congressional Resolution in honor of her outstanding contributions to the health of women and girls.

Read more from Cindy Pearson.