Klobuchar, Bipartisan Group of Members of Senate Judiciary Committee Urge FDA Commissioner to Address Abuses in the Regulatory Process that Delay Competition and Increase Prescription Drug Costs

Press Release

U.S. Senator Amy Klobuchar and a bipartisan group of members of the Senate Judiciary Committee have urged Food and Drug Administration (FDA) Commissioner Scott Gottlieb to address abuses in the regulatory process that delay competition and increase prescription drug costs. Commissioner Gottlieb recently stated that the FDA will take measures to curb anticompetitive abuses of its regulatory process for the approval of generic drugs. This goal that aligns with the objectives of legislation Senators Klobuchar, Chuck Grassley (R-IA), Dianne Feinstein (D-CA), Patrick Leahy (D-VT), Dick Durbin (D-IL), Sheldon Whitehouse (D-RI), Mike Lee (R-UT), and Richard Blumenthal (D-CT) introduced earlier this year, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.

In their letter, the senators advocate for their legislative solution and ask Commissioner Gottlieb to detail the regulatory actions the FDA can and cannot take to address strategies that prevent generics from obtaining samples needed for regulatory testing and abuses in the Risk Evaluation Mitigation Strategy (REMS) program.

"We applaud your interest in addressing abuses of the regulatory process that delay competition and increase prescription drug costs without enhancing patient safety. At the same time, the REMS issue is well understood, and the CREATES Act provides a simple and effective solution," the senators wrote. "We ask that by July 24, you respond with what regulatory actions you believe the FDA can and cannot take to address strategies that prevent generics from obtaining samples needed for required regulatory testing and abuses in the REMS program. We look forward to working with you to promote safe, effective, and affordable drug prices by fostering greater competition."

The CREATES Act combats anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block entry of lower-cost generic drugs. The legislation would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace.

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