The Government Accountability Office (GAO) released its report of the procedure involved in denying Barr Laboratory’s application to make Plan B available over the counter. Those following the debacle already know about the fishy reasons for rejection, but the GAO's report is a pretty stunning indictment (if you're new to the debate, I am nepotistically recommending my column over at Campus Progress as background).
According to the GAO several things were unusual about this approval process (from the report, but I've put them in bullet form for your easy reading pleasure):
• The directors of the offices that reviewed the application, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter.Okay, those are pretty serious irregularities.
• FDA’s high-level management was more involved in the review of Plan B than in those of other OTC switch applications.
• There are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed
• The rationale for the Acting Director’s decision was novel and did not follow FDA’s traditional practices.
The directors of the office that reviewed the application didn't sign the letter? Along with the director of the Office of New Drugs? That brings up some deeply troubling questions about the FDA. If the heads of department who are supposed to sign the letter do not, who makes the final call? The acting director, who is appointed by the current administration (Bush admin, in this case). It's clear the FDA should require all parties' signatures to prevent this kind of blatant politicking.
And there's even more politicking to be had:
The Plan B decision was not typical of the other 67 proposed prescription-to- OTC switch decisions made by FDA from 1994 through 2004. The Plan B OTC switch application was the only one during this period that was not approved after the advisory committees recommended approval. The Plan B action letter was the only one signed by someone other than the officials who would normally sign the letter. Further, there are no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B new drug application.Italics mine
As for the age question, numerous studies have shown that young girls, even if they're physically given Plan B to take home, show no increase in risky sexual behavior.
The science is against opponents of Plan B on every turn. Not only did the advisory panel conclude that Plan B is not an abortifacient (as anti-choice zealots claim), not only do numerous studies show no increase in risky behavior (despite the unusual request of having to prove this at all), but it's been used for years around the world and considered perfectly safe.
Clearly the FDA isn't concerned about science, but instead rejected an application due purely to politics. Because of their initial rejection, Barr had to revise its application to exclude girls under 16. What infuriates me so much about this is, of anyone, girls under 16 would be most profoundly affected by unplanned pregnancy. And the least able to get their own doctor appointment (you can't get a driver's license before 16, for God's sake) to get the prescription.
So what sorry excuse are opponents of Plan B using now that the report is public? The New York Times reported one response:
"We question the integrity of the investigative process that results in such partial conclusions by the G.A.O.," Ms. Zawisza said.I hate to break it to you, lady, but GAO stands for "Government Accountability Office". The whole point is they're supposed to investigate, impartially, what goes on in the government. Calling them partial is quite a red herring.
Lester Crawford already resigned over this -- I'm not sure many more people can be held accountable. And that's what's really sad -- there's nothing to be done but write blog posts and write your senators, and I don't expect much change to come out of that. I usually try to be more optimistic about individual power to change and what not, but it's clear in this case that it doesn't much matter.