Earlier this month, leaders on the Senate Committee on the Judiciary introduced bipartisan legislation designed to end what they describe as delay tactics used by brand-name drug manufacturers to block generic drug approval by the Food and Drug Administration. This legislation is part of an ongoing effort by Congress to address what it views as anti-competitive behavior (by drug manufacturers) that they believe bars consumers from having access to cost-saving generic drugs
The legislation, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, was introduced by Senators Charles Grassley (R-IA), Patrick Leahy (D-VT), Mike Lee (R-UT), and Amy Klobuchar (D-MN). The Senate Judiciary Committee’s Subcommittee on Antitrust, Competition Policy and Consumer Rights is scheduled to hold a hearing to discuss the bill on June 21. Already, the legislation is supported by the American Hospital Association, the American College of Physicians, the Blue Cross Blue Shield Association, Generic Pharmaceutical Association, AARP, Families USA, and others.
The CREATES Act was introduced on to address complaints raised by generic drug manufacturers that some brand-name pharmaceutical companies are engaging in delaying tactics to prevent potential competitors from obtaining samples of the branded product needed for testing to demonstrate it is equivalent to the brand-name product, as required for FDA approval. Concerns also have been raised that for brand-name products that require a distribution safety protocol (as part of a FDA-required Risk Evaluation and Mitigation strategy), some brand manufacturers are refusing to allow generic competitors to participate in a single, shared protocol which is required for the Agency’s approval.
The CREATES Act would prohibit these practices and allow generic drug manufacturers who experience one of these delay tactics to request injunctive relief in a federal court. The proposal also would authorize a judge to award damages in a monetary amount sufficient to deter future delay practices, as well as establish a limitation of liability on brand-name pharmaceutical companies that provide product samples to a generic product manufacturer.
Previously, the FDA reported receiving over 100 inquiries from generic drug manufacturers who were unable to access samples of an innovator drug to compare and test their generic product. Senator Grassley, Chairman of the Senate Judiciary Committee, and Senator Leahy, senior Democrat on the Committee, believe the legislation would reduce drug prices for consumers.
Arent Fox will monitor the developments of this legislation in Congress and other initiatives related the regulation of pharmaceutical drugs.