Morning-After Pill Causes Upheaval at FDA

An Expert Interview With Susan Wood, PhD

Neil Canavan, MSc

March 17, 2011

March 17, 2011 (Washington, DC) — Editor's note: Susan Wood, PhD, resigned her position as assistant commissioner of women's health at the US Food and Drug Administration (FDA) after repeated interference with the FDA's regulatory authority by outside influences during the review process for the contraceptive known as the morning-after pill. She remains a staunch supporter of the agency, but her experience serves to remind others that vigilance is key to regulatory integrity. Medscape Medical News spoke with her here at the American Medical Student Association (AMSA) 61st Annual Convention.

Medscape: Many contraceptives have been previously approved. Why is the morning-after pill different?

Dr. Wood: Part of the difference was the intention to make this new contraceptive method available over the counter, as opposed to needing a prescription. The drug has to be taken within 120 hours of intercourse, so ready access is critical. As a prescription product, it was not that controversial, but over the counter. . . . This prompted opposition from people who are opposed to contraception in the broader context; the potential of increased availability is what concerned them. It was also being confused with RU 486, the so-called abortion pill, because it's not intuitive to people that something taken after the fact is, by this particular mechanism, still contraception. The statements made by those opposed to it also contributed to public confusion. The process should have been routine, but it wasn't.

Medscape: When did it first occur to you that something was wrong with the way the regulatory process was proceeding?

Dr. Wood: We were all aware that something was wrong when the decision was first being interfered with early in 2004. This was after the advisory committee had met and made its strong recommendation to approve the drug without an age restriction — and the reviewers supported this position. But then the decision was taken out of the usual chain of decision-making and put into the higher reaches of the FDA. It wasn't until August 2005, when yet another delay for approval was imposed, that it became clear to me that that the process was wrong to the point of my not seeing how it could be fixed, and that's when I left.

Medscape: Was that the first time you saw the involvement of politics in a regulatory decision?

Dr. Wood: I've been careful over the years not to speculate on how the decision was taken off track. Certainly there was the thought that is was political, but what I really want to point out is that the science was ignored — medical evidence was ignored, and the way that the FDA usually does business was ignored, and that led to bad decision-making.

To be fair, I do think this was a fairly unusual case. The FDA, the individual reviewers, and teams face pressures every day from outside the agency (advocates of one sort or another), but they generally are able to maintain a focus through the proper lens, and that is: What do the data tell us? What is our legal authority? What is the proper way to make a decision?

Medscape: Did you have no choice but to leave?

Dr. Wood: I was the face of women's health, if you will, at the FDA. When a decision like that is made, which has a clear impact on women's health, in that it was denying access to a safe and effective contraceptive method for no good reason that could be explained, my choices were to remain silent, and thereby undermine my own professional and scientific credibility, or to be an internal whistleblower — speaking truth to power while remaining at my station. Staying would have been extremely stressful, and I didn't think I could have accomplished anything by doing so.

Medscape: Wasn't it a women's issue that led to the strengthening of the FDA?

Dr. Wood: That's the thalidomide story. Frances Kelsey was a brand new reviewer at the FDA when she was given her first assignment — the review of thalidomide — thinking it would be easy [it was already approved in Europe]. But when she looked at the data, she decided to block it from coming to the United States. Shortly thereafter, thousands of thalidomide-induced birth defects occurred, and it became clear that Kelsey had made a really good call. Her decision was so important that a reporter from The Washington Post brought the story public, and this was instrumental in pushing legislation forward [the Kefauver Harris Amendment] that gave the FDA much more authority in the area of drug safety and effectiveness. It was Dr. Kelsey's action that helped bring this about.

Medscape: If the morning-after pill was an isolated case, what would be the take-home from your presentation here?

Dr. Wood: What I would like students to understand is that the FDA is a vital and important agency, and there are many good people there trying to do the right thing, using good information to make good decisions as fast as possible. But because this is such a vital agency, we should maintain vigilance, while at the same time being supportive. This is not an agency to tear down — we are dependent upon the FDA, so we need it to be strong and effective, which at the end of the day frees up physicians to do their jobs and not have to worry about errant regulatory decisions.

Medscape: During your presentation, the room was overflowing, yet there were only 10 men in the audience. Were you surprised at that?

Dr. Wood: No. Unfortunately, it's common. When you talk about women's issues, it's the women who show up. I wish that were not the case, but it is.

Dr. Wood has disclosed no relevant financial relationships.

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