Regulators reach agreement on drug industry fees

{mosads}Under the recommendations for prescription drugs, the FDA said, “fees paid by industry would support continued timely review of critical prescription drugs, as well as advance the development of drugs for rare diseases, provide for enhanced communication with small or emerging companies, increase the use of standardized electronic data to improve quality and efficiency, and foster the use of new clinical endpoints that improve drug development times and help address unmet medical needs.”

The new generic user fees would help clear the backlog of applications, as generics are on the rise. The biosimilars fee, meanwhile, comes as President Obama’s healthcare reform law for the first time created a pathway for drugs that are almost identical to complex biologic drugs.

The FDA’s announcement comes one day after House Republicans announced a schedule of hearings on user fees next month.

“These user fee agreements are crucial to ensuring that medications become available to the American public quickly and safely,” the top lawmakers on the Senate HELP Committee — Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.) — said in a joint statement Friday. “We applaud the FDA and the industries for the dedication and hard work it took to finalize these agreements.

“Moving forward, we expect the FDA and the medical device industry to continue to work together to resolve any outstanding issues quickly so our Committee can move forward with the work to authorize all four user fee agreements in a timely manner. An agreement between FDA and the industry is critical to fostering greater innovation while ensuring that the review process for new medical devices is predictable, consistent, and transparent.”