Regulatory Reform Subcommittee to Hold Hearing on Antitrust Concerns with FDA Drug Approval Process

Washington, D.C. -- On Thursday, July 27, 2017 at 1:00 p.m., the Regulatory Reform, Commercial and Antitrust Law Subcommittee will hold a hearing to examine antitrust concerns with the Food and Drug Administration processes to approve new drugs. This hearing will continue the Subcommittee’s investigation of competition in the healthcare sector and will explore potential antitrust concerns with the FDA’s Risk Evaluation and Mitigation Strategy (REMS), citizen petitions, the Unapproved Drug Initiative, and “Pay-for-Delay” settlements. The witnesses for the hearing include: Panel I:

• Scott Gottlieb, M.D., Commissioner, Food and Drug Administration
• Markus Meier, Acting Director, Bureau of Competition; Assistant Director, Health Care Division, Federal Trade Commission

Panel II:

• Professor David Olson, Esq., Associate Professor of Law, Boston College Law School
• Professor Erika Lietzan, Esq., Associate Professor of Law, University of Missouri School of Law
• Alden Abbott, Esq., Deputy Director and Senior Legal Fellow, The Heritage Foundation
• Professor Aaron Kesselheim, M.D., Associate Professor of Medicine, Harvard Medical School

House Judiciary Committee Chairman Bob Goodlatte (R-Va.) and Subcommittee Chairman Tom Marino (R-Pa.) issued the following statements in advance of the hearing: Chairman Goodlatte: “The FDA’s approval processes were intended to protect consumers from harmful substances and respect the intellectual property of drug companies. Unfortunately, there are concerns that several of these administrative processes are being used to delay entry of generic drugs, thus increasing costs and limiting choices for consumers. I look forward to hearing from legal and medical experts to discuss the potential antitrust implications of the FDA’s procedures and explore legislative solutions to these healthcare problems.” Subcommittee Chairman Marino: “Competition in the pharmaceutical industry and marketplace is important to ensure patients receive high quality medications at the lowest cost. I look forward to hearing from FDA Commissioner Gottlieb, FTC Acting Director Meier, and the distinguished panel of experts on competition issues in the drug marketplace. Commissioner Gottlieb has been especially proactive in the drug pricing arena since taking over as head of the FDA. Of particular interest to me is hearing both panels’ views on the anticompetitive behavior in the FDA's Risk Evaluation and Mitigation Strategy (REMS) Program. My legislation that I introduced earlier this year, H.R. 2212, the Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act, deters pharmaceutical companies from utilizing anticompetitive behavior, while continuing to ensure consumer safety. I look forward to hearing testimony on the shortcomings of the REMS Program along with the other competition issues in the drug marketplace.” This hearing will take place in 2141 Rayburn House Office Building and will be webcast live at judiciary.house.gov. Camera crew wishing to cover must be congressionally credentialed and RSVP with the House Radio-TV Gallery at (202) 225-5214.