Who Do You Trust on Women's Health: Dr. Susan Wood Speaks Out to NWHN About the FDA

By Cindy Pearson

On August 31, 2005, Dr. Susan F. Wood resigned from her position as head of the Office of Women’s Health at the Food and Drug Administration (FDA) in protest over the agency’s handling of emergency contraception (EC). That month, the FDA announced that it would not approve Barr Laboratory’s application to make Plan B emergency contraception available over-the-counter (OTC). In Susan’s words: "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled." Susan has been busy since her resignation, talking to groups around the country about how the FDA is ignoring science and the threat this poses to women’s health. Cindy Pearson, NWHN’s Executive Director, caught up with Susan in Ann Arbor, Michigan, in early November. Below is a portion of their conversation.

Cindy: Susan, how did you see the process go wrong in relation to Plan B Emergency Contraception, and the request to make it available over-the-counter?

Susan: There were a couple of places where the process went wrong. First of all, in 2004, the Director for the Center for Drug Evaluation and Research overruled the decision of the scientific reviewers and the Advisory Committee’s recommendation that EC be made available over-the-counter. This overruling was very unusual because there was, essentially, consensus at every level below the Director that EC should be approved for OTC use. So, for the FDA to come out with a non-approvable letter was quite unusual, given the strong agreement in favor of over-the-counter approval at every level and of the Advisory Committee.

The second way the situation was unprecedented was that the FDA asked a question about an OTC product that we’ve never asked before. The FDA has never asked whether a small, specific group of the general public can understand a product’s label and use the product correctly. In this case, we asked about teens aged 16 and under. There is no evidence to suggest that EC is not safe and effective for these young teens, and there is no precedent for pulling them out as a special population and seeking greater restrictions on their use of a product.

And, what happened next was very different. The Center Director did not approve over-the-counter status, and then asked Barr Laboratory, which makes Plan B, to come back either with more data on these very young teens or a plan for providing Plan B by prescription for young teens and by non-prescription for everyone else. The company came back with that proposal as requested, and the Center was then prepared to approve it OTC for women 17 and older by early 2005. But for some reason, that approval was again delayed for months.

Cindy: And then, the Commissioner announced in August, 2005, that the FDA couldn't make a decision, because the agency needed to study whether or not it had the authority to make a product available over-the-counter only for a certain age group.

Susan: And that was another type of abuse of the process. That was used solely as a delay mechanism, not because it was necessary to protect the health of that group of people.

Cindy: Susan, from the outside, we women’s health advocates believed that the FDA’s unexpected decisions must have been influenced from elsewhere. We felt that, left to its own devices, the FDA wouldn’t have done what it did. You went to work there every day -- did you see things that made you feel like there was some sort of pressure coming from outside?

Susan: I think you're right: left to its own devices the FDA would have approved over-the-counter status for EC a long time ago. I don’t know what took our independence away from us, but I don’t think the agency was acting independently in this case.

Cindy: How did you make your decision to resign in protest?

Susan: A large part of it was feeling, sadly, that I didn't have a role; that I couldn't be a credible champion for women inside the FDA; and I couldn't be a credible voice for the agency to the public. So, it was better, then, that I not be a part of the FDA.

Cindy: Was it a hard decision to make?

Susan: The hard part was leaving the very dedicated, professional staff at the FDA and particularly within the Office of Women's Health. It was a wonderful job, a wonderful opportunity to be an advocate for women's health inside the FDA. I worked with great people who were getting things done every day. Having to leave these colleagues behind -- and leave the good work we were doing -- was very difficult. But, making the decision about what I thought was right to do was not hard!

Cindy: What are you worried about for the future?

Susan: Primarily, I worry that the FDA is not making decisions based on the principle of promoting the health of women, their families, and the public. I worry that the FDA’s credibility has been damaged. There are lots of good people at the FDA doing their jobs every day, but I worry that, in the long-term, the support of all these wonderful people inside the FDA is going to be lost because they won’t feel valued and their recommendations will be ignored or sidelined for political reasons.

Cindy: Are there any specific issues that you think may be vulnerable right now? Do you think the process is going wrong for other issues that we don’t know about yet?

Susan: Not being there, I don’t know what’s happening. But, I worry when I read the news reports about these same arguments being rolled out against the human papilloma virus (HPV) vaccine. Such a vaccine has the potential, if it is demonstrated to be safe and effective, to prevent cervical cancer -- since HPV is the main cause of cervical cancer, which is the second most common kind of cancer among women worldwide, and the 14th most common kind of cancer for U.S. women. I worry that that the same sorts of rationales and delay tactics, shown to be successful in blocking OTC availability of Emergency Contraception, can be applied to an HPV vaccine. In the area of vaccines, the issue of young teenagers is especially important because you’d want to give an HPV vaccine before they’re exposed to risk (through sexual activity), just the same way we give other vaccines before a person has been exposed to risk. But unfortunately, the same rationale is being used: that the HPV vaccine would promote sexual promiscuity. Which, besides being inaccurate, is an extraordinary argument: that you would put aside the value of something that could prevent cancer based on this erroneous idea.

Cindy: Susan, what do you think individuals can do to make a difference?

Susan: It's important to get information out. There’s much confusion out in the general public, even among those with medical expertise, about Emergency Contraception. EC is not an abortion pill. The mechanisms used with EC are the same as those used in other contraceptive pills. And, therefore, this is really a debate about the values of contraception -- which astounds me. That is really what we’re talking about here. People who oppose EC need to understand, if they don’t already, that it is the same thing as being opposed to other forms of hormonal contraception. And, they need to figure out if that’s where they really are. They need to understand that and change their view, or they need to acknowledge publicly that they’re actually opposed to other forms of contraception as well. Because they work by the exact same mechanism. The other rationales and arguments are just smokescreens.

Cindy Pearson is NWHN's Executive Director. Dr. Susan F. Wood is a current NWHN Board member.