Chairman Nadler Statement for the Markup of H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act
Washington, September 29, 2021
Washington, D.C. - Today, House Judiciary Committee Chairman Jerrold Nadler (D-NY) delivered the following opening statement, as prepared, during the markup of H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act:
"H.R. 2891, the 'Preserve Access to Affordable Generics and Biosimilars Act,' is a bipartisan bill that I introduced along with Representative Ken Buck to prohibit anti-competitive settlements, also called pay-for-delay agreements, that block access to affordable prescription drugs.
"These anti-competitive agreements allow branded drug companies to pay-off a generic competitor to delay entering the market with a lower-cost generic product. The result is that the brand-name drug company gets to keep its monopoly, and the generic gets paid off with a portion of the monopoly profits. Pay-for-delay agreements result in a financial windfall for both drug companies, but consumers inevitably lose.
"As the Biden Administration recently noted in its Executive Order on Promoting Competition in the American Economy, these 'deals between generic and brand name manufacturers reduce innovation—reducing new drug trials and R&D expenditures.'
"In response to this problem, H.R. 2891 would establish that these agreements are presumptively illegal under the antitrust laws, and would authorize the Federal Trade Commission to impose significant penalties on companies that engage in these pay-for-delay schemes.
"Although the Supreme Court held in FTC v. Actavis that pay-for-delay agreements could violate the antitrust laws, the FTC expends significant resources challenging what appear to be clear violations. This legislation would address that problem by requiring courts to view such agreements as presumptively unlawful.
"According to the non-partisan Congressional Budget Office, this legislation would save American taxpayers over half a billion dollars over ten years due to the high costs imposed on our healthcare system by this anti-competitive conduct."This bipartisan legislation passed unanimously out of the Committee last Congress and, this past July, an identical companion to this bill was advanced favorably by the Senate Judiciary Committee on a bipartisan basis. I urge my colleagues to take similar action and to support this important legislation."