FDA ruling indefinitely postponed

A few weeks ago, when Governor Pataki vetoed the Emergency Contraception bill, I mentioned that the FDA was going to issue a ruling on the safety of selling EC over the counter on September 1st. Well, September 1st has come and gone…and the ruling has failed to materialize. Lester M. Crawford, the FDA’s newly appointed Commissioner, decided to delay the decision (in a decision-making process that apparently involved very few of the top officials at the FDA). To say that this delay comes as a shock is a bit of an understatement; Crawford’s appointment was only confirmed by the Senate after he’d promised them to come to a ruling on the safety of EC by September 1st.

In other startling news, Dr. Susan Woods, the FDA’s Director of the Women’s Health Office, was so disgusted by Crawford’s delay and lack of decision that she resigned on the spot. In the e-mail she sent to coworkers explaining her decision, she stated: “I have spent the last 15 years working to ensure that science informs good health-policy decisions…I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended by the professional staff here, has been overruled.”

Crawford’s reason for the delay was questionable. While he conceded that Plan B (the morning-after pill) was safe as OTC medication for women 17 and older, he was concered that women 16 and younger would not be able to use it correctly and wanted Plan B to be only available by prescription for this age group. He delayed the ruling because he was unsure of how to properly enforce this distinction between age groups. However, when the FDA first raised this concern last year, it was suggested by the pharmaceutical company which makes Plan B that the age limit could be enforced the same way that drugstores currently enforce the age limit on cigarette and alcohol sales.

To quote USA Today’s article on the subject, “‘there’s fairly widespread concern about the FDA’s credibility’ among agency veterans as a result, Wood told The Associated Press hours after submitting her resignation Wednesday”. Senators Hilary Clinton and Patty Murray urged a Senate hearing on the matter, saying that “Science has taken a back seat to politics in the FDA’s decision-making process for Plan B”.

There was no firm statement made by Crawford about exactly when another ruling would be made, although he’s opened the question to public comment for at least another 60 days. So I think the message here is: don’t hold your breath.

Frankly, I can’t quite believe this has happened again: politics trumping good science and well-written bipartisan legislation, again. To quote Dr. Wood one more time (this time from the NY Time’s article on the subject): “I feel very strongly that this shouldn’t be about abortion politics…This is a way to prevent unwanted pregnancy and thereby prevent abortion. This should be something that we should all agree on.”

(The LA Times also wrote a fabulous article on the story.)