WASHINGTON – Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) alongside Senators Patrick Leahy (D-Vt.), Mike Lee (R-Utah), and Amy Klobuchar (D-Minn.) are asking Food and Drug Administration (FDA) Commissioner Scott Gottlieb to address anticompetitive practices currently used by some brand-name pharmaceutical companies to delay the manufacture and introduction of generic drugs in the market. Commissioner Gottlieb recently outlined his concerns with such abusive practices, which would be addressed by the bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, introduced by the authors of today’s letter and other senators.
The letter will be included in the record as part of the FDA’s public meeting about innovation in drug development and access to affordable drugs titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The letter discusses abuses of Risk Evaluation Mitigation Strategy (REMS) programs by certain brand-name pharmaceutical companies and urges Commissioner Gottlieb to consider using FDA’s authority to more readily waive the requirement for a single, shared REMS if, after a good faith effort or a reasonable amount of time, a generic drug company has submitted a separate proposal that satisfies REMS requirements. It also cites the need for Congressional action to pass the CREATES Act.
The senators wrote: “While we look forward to hearing more from you about what regulatory actions you believe the FDA can take to address strategies that prevent generics from obtaining samples needed for required regulatory testing and abuses in the REMS program, we believe Congressional action on the CREATES Act is necessary and an essential part of the solution to ending these abuses. We would welcome the opportunity to work with you on this legislative solution.”
The CREATES Act combats anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block the entry of lower-cost generic drugs in the market. The legislation would deter pharmaceutical companies from denying samples to generic companies for product testing and gives the FDA more flexibility to make determinations with respect to single REMS distribution systems.
Full text of the letter is below, and a pdf can be found here. An outline of the CREATES Act can be found here, and text of legislation can be found here.
