Healthcare stakeholders urge Senate to end REMS abuse

WASHINGTON  — In response to a recent hearing of the Senate Special Committee on Aging to examine factors contributing to “price spikes in off-patent drugs," the Generic Pharmaceutical Association 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 (H.R. 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,” stated Chip Davis, president and CEO, GPhA. “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.” 

      

REMS are FDA-mandated programs that provide additional information to patients and providers, and in certain cases restrict distribution of the product so that only specified entities have access to it. Some companies establish voluntary restricted distribution networks to deny manufacturers of generic and biosimilar drugs access to product samples they need to obtain FDA approval and market entry, GPhA noted. H.R. 2841 would cut down on these abuses and would save the federal government approximately $2.4 billion over 10 years, GPhA noted, citing a report from the Congressional Budget Office. 

 

“Any policymaker seeking ways to lower health costs should consider increasing competition from generic drugs by embracing measures such as the FAST Generics Act,” Davis said. “Competition from generic drugs has saved the health care system $1.68 trillion over the past decade and $254 billion in 2014 alone, according to the 2015 Generic Drug Savings in the U.S. report. We can do more to expedite patient access to safe, effective and more affordable generic drugs.”