The Latest on Plan B

After months of silence on the issue, today has been a big day for Plan B, the emergency contraception pill at the heart of a political battle involving the Food and Drug Administration (FDA). The Senate Committee on Health, Education, Labor and the Workforce held its first hearing today to determine whether it would give approval to Andrew von Eschenbach, nominee for FDA Commissioner. And yesterday, just ahead of this hearing, FDA sent a letter to Plan B’s manufacturer requesting a meeting to discuss its approval for over-the-counter sales.

After months of silence on the issue, today has been a big day for Plan B, the emergency contraception pill at the heart of a political battle involving the Food and Drug Administration (FDA). The Senate Committee on Health, Education, Labor and the Workforce held its first hearing today to determine whether it would give approval to Andrew von Eschenbach, nominee for FDA Commissioner. And yesterday, just ahead of this hearing, FDA sent a letter to Plan B’s manufacturer requesting a meeting to discuss its approval for over-the-counter sales.

The letter suggests that the FDA would be open to approving Plan B for OTC sales (not surprisingly: 23 out of 27 [see page 6] of FDA’s scientific experts recommended this for women of all ages). But the letter says approval will only be for women over 18, and even then with strict guidelines in place. Why 18? Apparently FDA deems this “an appropriate age.” Certainly not for reasons related to science.

That aforementioned panel recommended it as safe for women of any age. Von Eschebach’s predecessor, Lester Crawford, suggested that science supported use of the drug for women aged 17 and older. The choice of age 18 as the lucky number puts Plan B into a category with cigarettes and X-rated movies, “appropriate” only for adults, but it has little reflection on the reality that this is a pharmaceutical product. Before Plan B, FDA had been faithful in making its decisions based on scientific evidence alone. Even in this moment of supposed progress on the decision, FDA higher-ups are sticking to their guns and supporting an abnormal, ideological decision-making process.

Senators Hillary Clinton (D-NY) and Patty Murray (D-WA), for whom the letter appears to have been indirectly intended, have stood by their intention to place a hold on Dr. Von Eschenbach's nomination until the FDA issues a final decision on the drug. (To clear up confusion in the LA Times and elsewhere, this hold is contingent only on a decision, not an affirmative answer.)

So an eleventh-hour letter with controversial policy suggestions is delivered to influence a Senate vote. And this veiled apparent attempt to sway the Senators will not likely succeed.

FDA’s spokesperson (not making this up) had this to say about Dr. Von Eschenbach: “This is a model for how he currently makes decisions and will continue to as the leader of this critically important public health issue.” Some model for the director of a federal regulatory agency with a scientific charter… And just so that we know the political nominee and long-time friend of the Bush family is acting of his own accord, he had this to say: “''No one told me what I should or could do. No one told me what decision I must and must not take…”

Was he trying to win over his critics with this statement? Apparently he’s proud of the fact that he makes decisions like this one without input from anyone else. For a Bush Administration nominee who has lost favor with even the Family Research Council, one might think he’d welcome a chance to shift blame in a tense moment. Not so.

A committee vote on whether or not to send Dr. Von Eschenbach's nomination to the full Senate is expected soon.  The FDA letter to Plan B’s manufacturer, Barr Laboratories, requests a meeting with them within 7 days to discuss terms for possible approval.  Sort of ironic given that Barr has been waiting three years for the FDA… Rewire will keep you posted as this all progresses.