FDA controversy over Plan B contraceptive

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In 2001 dozens of public health groups around the world petitioned the FDA to make emergency contraception available over the counter, but the decision over whether to do that, and especially whether to make it available to women under the age of 18, dragged on for years bogged down in a political quagmire.

Dr. Susan Wood worked at the FDA during this period as the assistant FDA Commissioner for Women’s Health. She resigned in protest to the FDA’s handling of Plan B, the brand name of the so-called morning after pill. Now, another four years later, a federal judge has ruled that the FDA wrongly bowed to the pressure of the Bush administration in its decision making process and relied on politics and not science.

On "The Takeaway," Susan Wood, now a research professor at the School of Public Health at George Washington University, talks about where the FDA may go from here.

Wood explains the court ruling: "So the legal issue that the courts have been taking up for the last several years now is, did the FDA follow its normal process, did the experts outside and inside the FDA play their proper role in making the decision about whether a product is safe, effective, and under what conditions it should be made available — with a prescription or without.

"Where we are today is … that product was approved … for those 18 and older. And there had been numerous missteps along the way. And the court decision laid out those missteps in their ruling. The judge describe frankly what I had seen and heard and knew about over the years that I was there, and came down with the decision that the FDA did not follow the legal process of how it’s supposed to go about making its decisions, that … the final decision made by the leadership of the FDA, not by the scientists and physicians there, were arbitrary and capricious…"

Wood explains how Plan B works: "What we know about emergency contraception is that it’s just high-does birth control pills, it does not cause an early abortion. It is a way to safely and effectively prevent an unintended and unwanted pregnancy for that individual if she uses it in a timely fashion. It’s very important that it’s taken quickly after unprotected sex, and it can help a woman whose in a situation, whether due to rape or problem with contraception … if she’s in the unfortunate situation of needing emergency contraception … if it isn’t taken within hours, it really has no effect. And so the timeliness of it is very important, thus if you need to go to a doctor, get a prescription, get that prescription filled, you will end up missing that window of opportunity …"

Wood on the FDA under the Obama administration: "I think the judge’s ruling was quite consistent with what President Obama did just a couple of weeks ago, which was sign a Presidential memo directing all of those science agencies to really put science first, and to ensure scientific integrity in all of its decisions — whether its environmental decisions, or health decisions, or other regulatory or research work …"

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