Politics Trounces Science at the FDA -- And Needs to Stop

Now that I'm done with Ph.D qualifying exams, I can get back to politically-loaded issues and commentary on techie stuff! In the works: a MythTV box, the alluded-to Nintendo modification, and maybe some more handy Windows tricks that I've been using recently.

But tech takes time, which is in short supply for now. So, it's back to the usual. This particular topic resonates with me both as a concerned American and as a scientist. Specifically, the FDA is caving to what can only be conceived as political pressure to keep a medication known as 'Plan B' from becoming an over-the-counter drug, despite overwhelming scientific evidence of both the safety and efficacy of the medicine, which is very effective at preventing pregnancy within 72 hours of sex. (Of course, earlier is better.) It works like regular oral contraceptives, but with a higher dosage; if a woman takes it too late (after implantation of a fertilized egg) it will not prevent the pregnancy or harm the embryo.

After an advisory panel voted 23-4 in favor of making Plan B over-the-counter, internal FDA scientists reviewed the recommendation and also independently agreed.

In response, FDA leadership delayed a decision for more than a year. After political pressure from Congressional Democrats, the FDA promised a decision -- but ended up deciding 'not to decide' and instead opening a public comment period of 60 days. As a result, multiple internal staff scientists have resigned in protest. (And recently the embattled FDA Commissioner resigned -- coincidence?)

After listening to a podcast from NPR's Science Friday on the subject, I was so angry that politics is trumping both science and women's health that I have written my Congressional representatives. I urge you to do the same.

Dear Senator Feingold, Senator Kohl, and Representative Baldwin,

I am writing to you to express my concern about the Food and Drug Administration's handling of a request to make a brand of emergency oral contraceptive, commonly known as 'Plan B,' available over-the-counter. This single pill, if taken within 72 hours of unprotected intercourse, can effectively and safely prevent pregnancy. However, the sooner the medication is taken the more effective it is -- and if a fertilized egg has implanted itself in the uterus before the medication is taken, it will not work.

The FDA has evaluated the scientific evidence for the safety and efficacy of this medicine and overwhelmingly supported the decision (in a 23-4 vote of advisory panel experts) to make it available over-the-counter. This recommendation was based on an exemplary safety record and to make accessibility to the medication dramatically greater due to the narrow window of time that the medication is effective at preventing pregnancy. Following the recommendation, the FDA's internal scientists reviewed the application and agreed with the findings of the advisory panel.

However, the FDA has chosen to defer making a definitive decision on the subject repeatedly. Prominent scientists in the FDA have resigned in protest. As a scientist myself, I am deeply dismayed by what appears to be a politically motivated decision on behalf of the FDA leadership to keep this medication from women that can already be in a terrible situation.

There are some positions in the government that should be immune from partisan politics -- and the FDA should certainly be one of them. When politics trumps sound science, all Americans lose.

Please take whatever steps are necessary to bring this problem to the attention of the {Senate | House} and to swiftly address the issue.

Very Truly Yours,
Michael Bongard