Pallone Wants REMS Abuse Hearing

Rep. Frank Pallone (D-NJ), ranking Democrat on the House Energy and Commerce Committee, says the committee should hold a hearing to examine misuse of the FDA Risk Evaluation and Mitigation Strategies (REMS) program by drug companies looking to block, impede, or delay generic competitors from coming to market. In a letter to the committee’s Republican leaders, Pallone urged that they hold “a hearing soon on the anti-competitive practices of pharmaceutical companies and the abuses of FDA’s regulatory programs to delay generic competition. Ensuring robust competition in the pharmaceutical market is one tool to help address the increasing costs of prescription drugs, a concern that I believe all members of this committee share.”

Pallone says the committee should explore potential legislative solutions to the problem, including the Creating and Restoring Equal Access to Equivalent Samples Act of 2017 and the Fair Access for Safe and Timely Generic Drugs Act of 2017.