March 18, 2009
Sebok on Wyeth v. Levine
After Levine, Big Pharma is faced with a choice. If it can convince the Supreme Court to adopt the background reasons test set out by Judge Sloviter in Colaciccio, and Big Pharma can do the kind of work that was done by the SSRI manufacturers to produce a record upon which a court can predict agency "rejection" as I have defined it, then Levine may turn out to have produced a good result. If the background reasons test is rejected, then Big Pharma's best hope is to ask the FDA to issue regulations that incorporate its logic, and to hope that they can convince Justice Breyer to take up their cause once a preemption case under the new regulation is challenged.
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