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.
I attended the big annual BIO Convention this past week in San Diego. BIO is THE trade association for the biotech industry and the annual BIO Conventions are HUGE events. This year’s keynote speakers included Hillary Clinton and Richard Branson, to give some idea of how high-profile the BIO meeting is. One of the primary functions of the BIO meeting is to provide a variety of vendors and service providers a marketing opportunity. Wandering about the vast floor of the main exhibit hall provided an interesting perspective on the overall biotechnology industry, the vast majority of which is focused on developing products for human healthcare. download PDF