Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the FAST Generics Act

June 18, 2015

GPhA applauds Reps. Steve Stivers and Peter Welch for introducing the Fair Access for Safe and Timely Generics Act.

PRESS RELEASE

WASHINGTON, DC (June 18, 2015) — “GPhA applauds Reps. Steve Stivers (R-OH) and Peter Welch (D-VT) for introducing the Fair Access for Safe and Timely (FAST) Generics Act. This bipartisan bill would close loopholes that allow some drug companies to misuse the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) programs and other non-FDA mandated restricted access 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. Should these practices extend to biosimilars, $140 million in savings would be lost for every $1 billion in biologics sales, according to a study by Matrix Global Advisors.

When used as intended, REMS programs are important for patient safety. The FAST Generics Act sets forth more explicit legal requirements and processes for the acquisition of product samples by generic and biosimilar developers, at the same time putting safeguards in place to protect public health.

"This legislation is vital to maintaining competition in the pharmaceutical marketplace and ensuring patient access to affordable, life-saving medications,’ according to a laudatory letter from more than 10 diverse health stakeholders sent to Reps. Stivers and Welch.

GPhA looks forward to continued collaboration with members of Congress and the FDA to ensure safe and timely access to generic drugs and biosimilars.”