House lawmakers introduce bipartisan legislation creating user fees for generic drugs

{mosads}The legislation is based on agreements negotiated between the industry and the FDA over the past year. The agreement requires federal regulators to review 90 percent of applications within five years, effectively eliminating the backlog.

The Generic Pharmaceutical Association, a trade group, called for Congress to rapidly adopt user fee legislation.

“The generic industry has stepped up to the plate to do our part to help ensure U.S. drug safety, establish a more level playing field among all participants in the U.S. pharmaceutical supply chain and significantly reduce the time needed to commercialize a generic drug,” David Gaugh, vice president for Regulatory Sciences at GPhA, testified Thursday at a House Energy and Commerce Health subcommittee hearing on the generic user fees. “The [user fee] programs will help assure that American consumers continue to receive the significant cost savings from generics that, over the past dozen years, have provided more than $1 trillion in savings to the nation’s healthcare system.”

The bill was introduced by Reps. Tim Murphy (R-Pa.), Henry Waxman (D-Calif.), Frank Pallone Jr. (D-N.J.) and Joe Pitts (R-Pa.).