Congressmen introduce bill aimed at increasing drug competition

WASHINGTON — U.S. Reps. Gus Bilirakis, R-Fla., and Kurt Schrader, D-Ore., this week introduced a piece of legislation that is aimed at speeding up generic drug approval and creating incentives for competition. 

 

The legislation would require the Food and Drug Administration to act within six months on an abbreviated new drug application (ANDA) submitted for a drug for which there is no equivalent generic, or in the case of shortages. It also looks to encourage development of generics by giving priority review to companies that would successfully market a new generic competitor. It would also study how Risk Evaluation and Mitigation Strategies (REMS) are being used. 

 

“This important legislation will help countless Americans,” Bilirakis said. “These are hard times for many residents in my district and across our nation. This bill will encourage competition to keep drug prices affordable and give consumers more options. By fast-tracking generic versions of drugs that have already been approved by the FDA, we can help give patients access to the medications they need.”

 

The introduction of this legislation comes the same week that the FDA’s Center for Drug Evaluation and Research released a new Manual of Policies and Practices making it possible for ANDAs submitted for a drug that currently only has one generic version — what it calls single-source generics.