FTC Files Brief in Mylan v. Celgene

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Mylan, the generic drug company, is suing Celgene.  The issue is Celgene’s use of its REMS programs to deny Mylan to purchase Celgene’s drugs, which Mylan needs to develop generic versions.   REMS programs are FDA mandated and approved in order to ensure that access to some drugs is restricted when use in some populations poses unusual risks.  In the case of Celgene’s drugs, the REMS programs are designed to insure that the drugs are not dispensed to women who are pregnant or may become pregnant while taking the drugs.  This is a significant move by the FTC against the increasing use of REMS programs to thwart generic competition.  Obviously the use of the drugs in bioequivalence testing by Mylan should take all necessary precautions to avoid exposing pregnant women to the drug, but that is not really Celgene’s objective.  The FTC’s brief is here.  Let us hope the FTC’s position prevails in this case.

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