Playing It Too Safe?: FTC Investigating Use Of REMS To Block Generics
The Federal Trade Commission is looking into whether companies are using their Risk Evaluation and Mitigation Strategies to thwart generic competition.
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FTC files second amicus brief saying use of risk management programs to impede generic competition could violate antitrust laws; commission launched an investigation of Celgene four years ago.
Agency will wait until it has more experience with shared REMS before deciding whether to issue regulations or guidance on their implementation, but for now it hopes sponsors can work out problems on their own.
Generic companies say innovators are using voluntary restricted distribution programs to prevent them from obtaining reference drugs for bioequivalence testing; a July hearing is set in a dispute involving Actelion’s Gaucher disease drug Zavesca, which is not subject to a Risk Evaluation and Mitigation Strategy.