November 1, 2016 / 11:06 AM / 2 years ago

Q&A: Harvard's Ameet Sarpatwari on REMS and generic drug competition

As public scrutiny of drug prices in the U.S. continues to intensify, Congress has an opportunity to consider a bill that would address a little-known obstacle to cheap generic drugs: a government safety program, called Risk Evaluation and Management Strategies, that can stop generic drug companies from getting the samples of brand-name drugs they need to develop their generic equivalents. The Creating and Restoring Equal Access to Equivalent Samples, or CREATES Act, introduced in June by Senator Patrick Leahy, a Democrat from Vermont, with Democratic and Republican cosponsors, would require brand-name drug companies to provide generic companies with samples in some circumstances. The Judiciary Committee’s Subcommittee on Antitrust, Competition Policy and Consumer Rights held a hearing on the bill in June, but so far, no more action has been taken.

Ameet Sarpatwari, an instructor at Harvard Medical School with a law degree from the University of Maryland, has written extensively about the effect of REMS programs on competition and pricing. He spoke to Reuters recently about how REMS can provide a pretext for keeping generic drugs off the market and how legislation could address the issue. Questions and answers have been edited for length and clarity.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2f8A2Ib

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