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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.

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