June 23, 2004

Plan B
Posted by Jon Henke

Kevin Drum links to this post over at Econ4Dean, in which "Lerxst" decries "Rovian tactics" surrounding the approval of the Plan B birth control method. A WSJ story, per Lerxst, "makes clear that it is conservative politics and not science which as at issue". (the gist of the story is that the FDA head--a political appointee--disagreed with the recommendation of the advisory panel of scientists)

Kevin calls it evidence of the Bush administrations "nanny state desire to control our sex lives, increase the rate of abortion, and gin up phony excuses to justify it". Lerxst calls it "misuse of science for political gain".

Pretty strong charges. So, what happened? Per the NYTimes, the FDA simply told Barr Pharmaceuticals that they were allowed to sell the drug over the counter, provided they do one of two things:
1: "...undertake a new study among girls 16 years old and younger to show that they can use the drug safely without the help of a doctor."
Or:
2: "...write a new label and construct a system that would allow women older than 16 to buy the drug over the counter while those younger than 17 would be forced to get a prescription."

So, in this example of Bush administration malfeasance, they....approved the sale of Plan B to everybody 17 and over? And approved the sale to women 16 and under as soon as Barr Pharmaceuticals provides research confirming the safety?

"But", critics say, "there's no scientific basis for the restriction on girls 16 and under!" Really? That's not what maker of the drug found.....

Comprehension rates among subjects with different Demographics

Ages (Table 5): Significantly fewer subjects ages 12-16 understood objectives #1A, #2, #4 and #6 compared with those ages ≥ 17 years.

In short, girls under 16 don't understand proper utility and usage of Plan B. This is not a political opinion....this is scientific research from the maker of the drug.

And at the end of the day, the FDA is willing to approve this drug with no restrictions at all, provided Barr Pharmaceuticals simply does the research on younger females that they did on older females. Research which Barr Pharmaceuticals failed to do when submitting their revised proposal.

What does the FDA say about Plan B? A full Q&A can be found here, including this statement...

Wide availability of safe and effective contraceptives is important to public health. We look forward to working with the sponsor if they decide to pursue making this product available without a prescription.
Critics of this decision are upset that the Bush administration blocked a legitimate drug.....but, in fact, it has been approved, conditionally. The "Not Approvable" letter simply lays out 2 alternative paths that will lead to approval of the drug, and it is consistent with the reservations expressed in the research by the maker of Plan B.

If the Bush administration is trying to play up to religious lobbying groups, one would think it would involve something a bit more satisfying than over-the-counter approval for women 17+, and approval for 16-and-younger conditioned on only a bit of research.

What's more, one would think that people who accuse the Bush administration of side-stepping research would be a bit more supportive of an FDA demand for, you know, research.

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Comments

Jon,

Maybe nobody else will say it but you have done a phenomenal job of cutting through the politically charged haze around the "reproductive rights" debate and presented the simple facts of this matter.

That the FDA is simply doing its job regulating medical products is unremarkable. Ditto the fact that, by doing so, the feathers of those with political agendas get ruffled. That someone can see the facts of the matter and describe them succintly is praiseworthy.

Posted by: D at June 23, 2004 10:40 AM