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GPhA Welcomes Senate Hearing to Examine REMS Abuse by Certain Brand Drug Companies, Identify Ways to Boost Patient Access to Affordable Medicines

Contact: Steve Arnoff 202.249.7113 

WASHINGTON, DC (June 21, 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).

Visit for more information on GPhA efforts to enhance patient access to safe and more affordable medicines.

The CREATES Act (full) (summary)
CREATES Act stakeholder support letter
Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry 
The Hill: Strengthening REMS for Patient Safety, Faster Access to Generics
AP: Drug Distribution Becomes Weapon to Block Competition

About the GPhA Biosimilars Council
The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha.