EC’s Lesson: People Make Change Happen


The last week of August is full of anniversaries for me, both public and personal. August 24 marked one year since the partial approval of Plan B emergency contraception over-the-counter (OTC) for those over 18 years old. Two days later, August 26, is the 87th anniversary of the day that women got the right to vote, Women’s Equality Day. It also is the second anniversary of the day that FDA leadership once again denied the approval of Plan B OTC despite all of the evidence and support within FDA for its approval. August 31st, just five days later, marks the two-year anniversary of my resignation from FDA as Assistant Commissioner for Women’s Health in response to the August 26th decision.

Looking back on the last two years and considering what has happened over the last year in particular – after emergency contraception got partial approval for sale without a prescription – I can draw a few lessons from my experience.

First, individual people working together can make a difference. All those people around the country who were outraged over the continued delay in permitting women access to a safe and effective contraceptive method managed to get their voices heard. The realization that those opposed to contraception somehow managed to thwart the scientists and physicians at FDA from doing their jobs was a surprise and a bit of a shock to folks from all walks of life. I think that this realization and the response of the public led to the ultimate approval (limited though it is) of emergency contraception OTC. We should remember this as we face continuing challenges in this arena and in others.

The second lesson I draw is not a surprising one to me. The sky didn’t fall, and women have begun to get access to one more option to help them prevent unwanted pregnancies. Timely access to emergency contraception should not have been and should not be a controversial subject. Those who have heard me on this subject know that this is a mantra for me. Even though people may keep their own contraceptive choices private, contraception is not a controversial subject. It doesn’t shock the vast majority of people in the United States to think that most couples have used and continue to use contraception. The details for any particular couple may be more information than most people want to know (that’s why it’s private), but access to contraception itself is widely supported and assumed. One more method available to women – and one that can provide a second chance – is a common good. It neither promotes promiscuity nor serves as a magic bullet in preventing all unintended or unwanted pregnancies, but it provides a woman with another form of prevention, should she need it.

Looking forward we have to continue to work to ensure that the health of the public remains our priority. There are still those who want to deny women access to contraception (emergency contraception or otherwise). Some of them are in the pharmacies, some of them are in hospital emergency rooms, some of them are in the government, but they are a small minority of the public and they shouldn’t be able to force their opinions either on women seeking contraception or on government agencies (like FDA) making health policy decisions. I think we can get there.

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  • http://thewelltimedperiod.blogspot.com invalid-0

    First, individual people working together can make a difference. All those people around the country who were outraged over the continued delay in permitting women access to a safe and effective contraceptive method managed to get their voices heard.

    With all due respect, this cannot be further from the truth. The only reason Plan B received OTC approval, such as it did, was because of some political horse-trading between Sens. Murray and Clinton and the administration (the Senators didn’t block von Eschenbach’s nomination to become the FDA’s permanent chief in exchange for the drug’s approval).

    We, the “lowly masses”, had no say in the matter. And the only difference we made (and not in a good way) is that we allowed the situation to deteriorate to the point where, for the first time in the FDA’s history (please correct me if I’m wrong about this), the agency made a decision about a drug’s OTC status not based on science but rather on how well equipped the corner store was to card people and to make it less confusing for pharmacists to enforce.

    The only way for individual people to manage to get their voices heard (not to mention to have their repro health needs properly addressed) is to exclude any and all politicians from having a say in their medical decisions.

    [Oh, and not having people like Dr. Steven Galson, Director, Center for Drug Evaluation and Research, who publicly admitted he's not even familiar with Plan B's side effects, in charge of making public health decisions about Plan B would also help.]

  • susan-wood

    Sens. Clinton and Murray were indeed the leaders in Congress pushing for the FDA to move back (at least partly) in the right direction, and their actions precipitated the FDA change in direction. But they were successful because during that round (in 2006) they actually had the support of enough other Senators in blocking the FDA commissioner confirmation.

    The previous year (and previous commissioner confirmation), they did not have the votes to actually block the nomination and had to accept what turned out to be a false promise.

    I assert that the difference was that people were raising their voices in small and large ways so that Senators from states beyond NY and WA were willing to back Sens. Clinton and Murray and stand up against the FDA (and the confirmation), whereas those same senators didn't/wouldn't previously. People were able to "get their voices heard" through the actions of politicians – which is what we elect them to do.

    I agree we shouldn't have let things deteriorate to the point that we were in, but it still gives me some hope that we can restore things in the end.