The Obama Administration’s Plan B for Plan B: Compliance, or Defiance?

by Lisa Heinzerling | June 11, 2013

The Obama Administration’s announcement that it will comply with a district court’s order that it make emergency contraceptives available to all women and girls without a prescription comes as a welcome development in a long-running administrative-law fiasco. But the Administration’s specific suggestions as to how it will set things right, set forth in letters sent yesterday to the district court and to the citizen petitioners who originally asked for nonprescription access to emergency contraceptives, are inadequate in several respects.

First, under the government’s approach, we will all have to wait for Teva Branded Pharmaceutical Products R&D, Inc. — the sponsor of the one-pill emergency contraceptive, Plan B One-Step — to submit a new application asking for full over-the-counter status for its product before anything can happen to implement the court’s ruling. The government’s letter to the court announcing its compliance with the court’s ruling, and its letter to the citizen petitioners announcing its granting of their petition, set forth no deadline within which Teva must submit a new application. For all we know, Teva is uninterested in submitting such an application. As the government revealed in the district court proceedings, 99 percent of Teva’s market is covered by the application the FDA approved in April of this year. Why should Teva want more? Perhaps it is satisfied with what it has. In any event, nothing in the government’s “acquiescence” requires any action at all from Teva, and thus the government’s actions are utterly dependent on the ...

The FDA Doubles Down On Its Plan B Troubles

by Lisa Heinzerling | May 29, 2013
Cross-posted on ACSBlog. 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 ...

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