GPHA Welcomes Senate Hearting to Examine REMs Abuse by Certian Brand Drug Companies, Identify Ways to Boost Patient Access to Affordable Medicines

JUNE 20, 2016

The Generic Pharmaceutical Association (GPhA) welcomed today’s Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights hearing, The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition. The hearing focused on provisions in the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act that help stop misuse of Food and Drug Administration (FDA) Risk Evaluation and Mitigation (REMS) programs and certain brand drug companies’ voluntary adoption of similar restrictions despite the lack of any FDA mandate. Experts note that these manipulations block generic and biosimilar competition, limit patient access and lead to higher drug prices.

GPhA member Beth Zelnick Kaufman, Assistant General Counsel, Amneal Pharmaceuticals, testified at today’s hearing. She said:

“The CREATES Act provides essential relief and remedies when brand companies refuse to provide samples on commercially reasonable terms or drag their feet during shared REMS negotiations. It will help make the promise of affordable medicine a reality for more Americans.”

Zelnick Kaufman’s full testimony is available here.

“The CREATES Act is a bipartisan solution to stop REMS abuse and limit similar restrictions that certain branded drug makers use to limit competition,” said Chip Davis, President and CEO, GPhA. “GPhA is pleased that the Senate is choosing to shine a light on brand drug company ploys to block patient access to safe, effective and more affordable generic and biosimilar medicines. A diverse group of health experts, providers, stakeholders, economists, regulators and others recognize that a legislative remedy is needed to stop REMS abuse and encourages swift passage of the CREATES Act.”

The CREATES Act (S. 3056) was introduced last week by Senate Judiciary Committee Chairman Chuck Grassley (R-IA), Ranking Member Patrick Leahy (D-VT), and Antitrust, Competition Policy & Consumer Rights Subcommittee Chairman Mike Lee (R-UT) and Ranking Member Amy Klobuchar (D-MN).