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 HarkinTom HarkinGrassley challenger no stranger to defying odds Clinton ally stands between Sanders and chairmanship dream Do candidates care about our health or just how much it costs? MORE (D-Iowa) and Mike EnziMike EnziA guide to the committees: Senate GOP senators unveil bill to give Congress control of consumer bureau budget Grizzlies, guns, and games of gotcha: How the left whiffed on Betsy DeVos MORE (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."