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Pallone Requests Hearing on REMS Abuse

Jul 9, 2018
Press Release

Washington, D.C. – Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) today requested Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael Burgess (R-TX) schedule a hearing to examine misuse of the Risk Evaluation and Mitigation Strategies (REMS) program by pharmaceutical manufacturers in an effort to block, impede, or delay generic competitors from coming to market.

In a letter to the Chairmen, Pallone also requested that the hearing explore potential legislative solutions including H.R. 2212, the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES) of 2017, a version of which passed through the Senate Judiciary Committee by a vote of 15-6, and H.R. 2051, the Fair Access for Safe and Timely (FAST) Generics Act of 2017.  

“I would urge you to a hold a hearing soon on the anti-competitive practices of pharmaceutical companies and the abuses of FDA’s regulatory programs to delay generic competition,” Pallone wrote to Walden and Burgess.  “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.”

Food and Drug Administration (FDA) Commissioner Scott Gottlieb has been outspoken about pharmaceutical manufacturers’ “gaming” of regulatory rules to delay generic competition and recently directed FDA to take action on certain manufacturers’ misuse of REMS programs to block generic entry. 

FDA has taken action to combat REMS abuses, including identifying 50 companies that denied requests for access to their samples from over 150 generic drug manufacturers and issuing guidance intended to address some back-end abuses of the REMS program.  Pallone wrote that these actions are helpful, but more must be done to prevent pharmaceutical manufacturers from abusing the REMS program once and for all.

“This hearing is necessary at a time when many Americans simply cannot pay for the medicines they need.  Over the years, the availability of generic drugs has helped to make treatments more affordable and accessible for those that need them,”  Pallone continued in his letter to Walden and Burgess.

According to FDA, generic drugs – which are bioequivalent to their brand-name counterparts – have saved our health care system almost $1.67 trillion over the past 10 years.

A broad coalition of stakeholders support policy that would help deter abuses of REMS and facilitate access to samples that will help with the development of generic alternations, including AARP, the American Hospital Association, the Campaign for Sustainable Rx Pricing, America’s Health Insurance Plans, Freedom Works, and Pharmaceutical Care Management Association, among others.

The letter is available HERE.