Congressman Sarbanes Introduces Bill to Curb “Pay-For-Delay” Agreements – UPDATED with Proposed Legislation

On July 23, 2018, Congressman John Sarbanes (D-Md.) introduced a bipartisan bill, the Biosimilars Competition Act of 2018, meant to curb “pay-for-delay” agreements entered into by biologic and biosimilar drug manufacturers.  According to Congressman Sarbanes, the purpose of the bill is to help lower the cost of prescription drugs by affirmatively giving the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) a role in reviewing such agreements.  The bill would require biologic and biosimilar drug manufacturers to notify the DOJ and the FTC of agreements that would delay the entry of biosimilar products in the U.S. market.  Under the Medicare Modernization Act of 2003, agreements that delay the entry of small-molecule generic products are subject to review by FTC and DOJ.  Stay tuned for a copy of the bill when it becomes available.

UPDATE: The text of the proposed bill can be found here: Biosimilars Competition Act.  This bill was provided courtesy of the bill’s co-sponsor, Rep. Bill Johnson (OH-06), and is not yet available on-line.