House and Senate Revive Bill Targeting Generic Drug Delays

Posted 27 April 2017 By Zachary Brennan

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Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs. 

Known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, the resurrected bill targets sample sharing (when brand-name drugmakers prevent generic firms from obtaining samples of the branded products so the generic company cannot perform necessary tests) and shared safety protocols (when brand-name manufacturers whose products require a distribution safety protocol, known as a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use or “REMS with ETASU,” refuse to allow generic companies to participate in that safety protocol).

If the CREATES Act becomes law, generic drug manufacturers would be able to bring an action in federal court for injunctive relief (i.e. obtain the samples they need). The bill also authorizes a judge to award damages to deter future delays.

In a hearing on the initial bill last June, Professor Robin Feldman, director of the Institute for Innovation Law at the University of California Hastings College of the Law, cited the US Food and Drug Administration’s (FDA) claim that it has received about 100 letters of inquiry on the misuse of REMS and noted that based on her review of 13 years of generic drug data, “REMS abuse has gone on for a while.”

The Congressional Budget Office also estimates that the bill would result in a $3.3 billion net decrease in the federal deficit, according to the bill’s authors.

Sens. Chuck Grassley (R-Iowa), Dianne Feinstein (D-CA), Amy Klobuchar (D-MN) and Mike Lee (R-UT) co-sponsored the Senate bill alongside Leahy, while Reps. Tom Marino (R-PA) and David Cicilline (D-RI) co-sponsored the identical House bill.

Bill Text

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Categories: Generic drugs, Clinical, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: CREATES Act, generic drug delay, REMS, Leahy

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