Regulators reach agreement on drug industry fees

By Julian Pecquet - 01/13/12 05:48 PM ET

The Food and Drug Administration finalized its recommendations for drug industry fees on Friday and sent them to lawmakers for their approval.

Federal officials have been working with drug makers for months to develop new user fees that fund the regulators who review the safety and efficacy of new medicines before they can get to market. The FDA is seeking to renew prescription drug user fees that expire Sept. 30 and create two new user fees, for generic drugs and more complex biosimilars.

"These final recommendations offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal," FDA Commissioner Margaret Hamburg said in a statement. "At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion."

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."