A panel of the Second Circuit Court of Appeals in New York has just taken under consideration the Food and Drug Administration’s motion for a stay of a district court order directing the agency to make levonorgestrel-based emergency contraceptives available to women and girls of any age without a prescription and without other point-of-sale restrictions. In deliberating on this motion, the panel of judges should not, I am sorry to say, take anything the FDA has said in its briefs at face value. The government’s opening and reply briefs on the motion to stay are so full of misstatements and omissions that the court could badly err if it did not take everything the government says with a shaker full of salt.
One of the factors in deciding whether to grant a stay pending appeal is the likelihood that the moving party will succeed on the merits. The government devotes most of its briefs to this factor. It makes two arguments as to why the court of appeals should find that the government is likely to win on appeal and should thus stay the district court’s order on emergency contraception. Both arguments depend crucially on incomplete and inaccurate renderings of the law and facts of the case.
Before turning to these arguments, a bit of context is necessary. The levonorgestrel-based emergency contraception at the center of this legal dispute takes two forms. One, Plan B and its generic versions, requires two pills. The other, Plan B One-Step and its generic versions, requires one pill. Both involve the same total dose of levonorgestrel. Despite these obvious similarities, the FDA has worked very hard to treat these drugs very differently; it has made Plan B One-Step available without a prescription to all women and girls over the age of 15, it has apparently blocked nonprescription market access to generic versions of Plan B One-Step for girls under 17, and it has resisted requests to make Plan B and its generic versions available without a prescription to girls under age 17. The district court’s order would make all of these drugs (except Plan B, which is no longer marketed) available without a prescription; the FDA would like to keep treating them differently.