You don’t want your 13-year-old running around town at midnight looking for a pharmacist on duty just to get hold of some Plan B, do you?
Believe it or not, this guy is … a Reagan appointee.
Describing the restriction as “a strong showing of bad faith and improper political influence” Judge Edward Korman of the District Court of Eastern New York directed the Food and Drug Administration to lift it within 30 days.
“The decisions of the Secretary with respect to Plan B One-Step…were arbitrary, capricious, and unreasonable,” Judge Korman wrote, directing the FDA to “Make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days.”
Health and Human Secretary Kathleen Sebelius rejected in 2011 a request to allow teenage girls and women to buy Plan B over-the-counter in drugstores and pharmacies. In doing so, she overruled the FDA, which was set to rule that the morning-after pill be made available to all women, with no prescription necessary.
It’s “arbitrary” for the Secretary of HHS to distinguish between adult women and minors, who are under the legal supervision of adults and who, needless to say, are at a different stage of physical and psychological development? It is in the context of administrative law, says the judge. A key bit from his opinion:
This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed…
I pause to add these brief words before I begin the discussion of the legal issues. This case has proven to be particularly controversial because it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs and because of the scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs. Nevertheless, the issue in this case involves the interpretation of a general statutory and regulatory scheme relating to the approval of drugs for over-the-counter sale. The standards are the same for aspirin and for contraceptives. While the FDA properly recognizes that cognitive and behavioral differences undermine “the ability of adolescents to make reasoned decisions about engaging in sexual intercourse,” the standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug “safely and effectively.” Ex. A-4 to Pls.’ 2007 Mot. for Summ. J. at T-31097, Case No. 05-cv-366, Doc. No. 235-5. I decide this case based only on my understanding of the applicable standard.
The FDA thinks OTC availability for minors is safe-ish and Sebelius isn’t offering any hard evidence that it isn’t, so that’s that. Not even the secretary of HHS is allowed to limit access to drugs for purely moral/political reasons, even with the president’s endorsement. (And do note, before the left gets going on those prudish wingnuts who fret about young teens accessing Plan B on demand, Obama supported Sebelius’s decision to deny the drug to 16-and-unders.) I’m at the mercy of administrative-law litigators as to whether the legal standard applied here is correct or likely to be reversed on appeal, but presumably Congress could impose the prescription requirement for minors as a matter of federal statute. After all, they have lots of experience with drug distinctions that are more arbitrary than this. Would there be any political will to do so, though? Democrats don’t want this debate because defending a 13-year-old’s right to the morning-after pill without a prescription is … suboptimal politics, which of course is why Sebelius and Obama tried to restrict it. The GOP probably doesn’t want this debate either because it’ll instantly become fodder for liberal slippery-slope shrieking about theocracy and how conservatives want to ban all forms of contraception, even for adults, blah blah blah. Opponents’ best bet is winning on appeal, if not in the Second Circuit then in the Supreme Court. But as to the odds of that happening, I honestly can’t say. Any admin-law experts want to weigh in?