Letter to Maureen Ohlhausen, Acting Chairman of the Federal Trade Commission - Senators Urge FTC to Release Pay-for-delay Agreements Report

Letter

Dear Acting Chairman Ohlhausen:

We write to request the prompt release of the fiscal year (FY) 2015 and 2016 staff reports on agreements filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, as well as a timely release of the FY 2017 staff report.

Since 2004, the Federal Trade Commission (FTC) has released annual reports summarizing agreements between brand and generic pharmaceutical manufacturers, providing important information on the use of pay-for-delay provisions in patent dispute resolutions. These pay-for-delay agreements, in which brand name drug companies pay generic drug companies to delay the marketing of the generic alternative, deny consumers access to more affordable alternatives to brand medications.

This information is critical to understanding the impact of pay-for-delay agreements. We appreciate that you have been very supportive of the FTC's Pay for Delay enforcement, and the FTC's prior reports have contributed to the public's understanding of this issue. As we seek to address these anticompetitive practices through legislation, it is important that we have up-to-date numbers to inform our efforts.

This information will help us understand the impact that the 2013 Supreme Court case FTC v. Actavis has had on patent dispute resolution and the FTC's ability to stop these anticompetitive deals. Although the decision clarified that these agreements are subject to antitrust scrutiny, the FTC has brought only a few cases since that decision.

The FY 2014 report found that the number of potential pay-for-delay agreements had fallen after the Actavis decision, but there were still over 20 potential pay-for-delay deals covering over $6 billion in prescription drug sales. Release of the FY 2015 and 2016 numbers will help Congress understand whether the Court's decision has altered the behavior of drug manufacturers and what legislative reforms are currently needed.

It is for these reasons that we respectfully request that you provide the dates on which you will release the FY 2015 and 2016 reports, in addition to the projected date for releasing the FY 2017 report, within two weeks of this letter.

Thank you for your attention to this important issue. We look forward to working with you to protect consumers and encourage competition in prescription drug markets.

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