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Statement from Ralph G. Neas, President and CEO, GPhA, Regarding FDA Draft Guidance on REMS Procedures


WASHINGTON, DC (December 4, 2014) –

“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies (REMS) programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.

The FDA draft guidance comes at a time when this issue is also receiving elevated attention in Congress. GPhA is pleased that Congressman Steve Stivers (R-OH) and Congressman Peter Welch (D-VT) introduced the bipartisan Fair Access for Safe and Timely (FAST) Generics Act, which effectively prohibits companies from adopting restricted access practices to avoid generic competition, a maneuver that comes at the expense of patient access to affordable medicines. The Association and its members look forward to working with legislative and regulatory partners to ensure that millions of people have safe and timely access to more affordable generic drugs and biosimilars.”

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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.