US generic drugmakers urge Senate to end REMS abuse, increase generic competition

In response to a recent hearing of the US Senate Special Committee on Aging to examine factors contributing to “price spikes in off-patent drugs,” the Generic Pharmaceutical Association (GPhA) and 10 stakeholder groups representing pharmacists, chain drug stores, pharmacy benefit managers, public and private retirement systems, and others, sent a letter to the Committee calling for consideration of the Fair Access to Safe and Timely (FAST) Generics Act (HR 2841) to improve competition in the pharmaceutical marketplace.

The FAST Generics Act would strengthen Risk Evaluation and Mitigation Strategies (REMS) and prevent some brand drug manufacturers from exploiting loopholes in the law that block patient access to safe, effective, affordable generic drugs.

“Misuse of FDA REMS patient safety programs is one way that certain brand drug companies delay generic competition,” said Chip Davis, president and chief executive f the GPhA, adding: “Failure to address the loophole that makes these abuses possible is a missed opportunity to encourage more competition in generic drugs and to generate billions of dollars in additional savings for patients and the health system.”