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REMS Abuse Website: Has It Changed The Behavior Of Innovators?

 
• By Michael Cipriano

Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.

The Shame
Has FDA been effectively shaming pharma companies? • Source: Grey World

The Association for Accessible Medicines (AAM) has contended that the US FDA's public list of drug companies suspected of using risk evaluation and mitigation strategies (REMS) to stonewall generic developer access to branded samples has done little to change the behavior of innovators. Based to the most recent data posted by the agency, the generic drug trade association may have a point.

Since the list was published in May 2018, there have been 10 additional inquiries into brand drugs and three new safety determination letters sent to innovators. Inquiries consist of generic...

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