The Society of Chemical Manufacturers and Affiliates called on the FDA to seek lower fees for small and first-time manufacturers under the Generic Drug User Fee Act and to ensure that inspections of domestic facilities don't suffer as the agency increases its focus on foreign inspections. The Generic Pharmaceutical Association said the FDA has $277 million in unused funds that could be used to reduce review times.
Fewer blockbuster drugs losing patent protection, the Supreme Court ruling allowing lawsuits against patent settlement deals, a decision allowing generic-drug-makers to update labels based on new safety information and higher FDA user fees combine to create a challenging business climate for the generic-drug industry, a Moody's Investor Service report finds.
Generic-drug makers reached an agreement with the FDA about paying user fees to hasten the approval process
and increase inspections of factories in other nations. The program, subject to congressional approval, calls for the agency to collect $299 million during the initial year. "If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough," said Commissioner Dr. Margaret Hamburg. "FDA's entire generic-drug program would be placed on a much more stable footing."
Mylan, Watson Pharmaceuticals and other generic-drug makers are gearing up for negotiations with the FDA about paying user fees to speed up product approval and facility inspection. Executives hope to come up with a unified plan at this week's Generic Pharmaceutical Association meeting. "We must be able to move when [brand-name] drugs come off patent," Mylan President Heather Bresch said.
An FDA report presented at the annual meeting of the Generic Pharmaceutical Association shows that the agency is lagging in its review of generic-drug applications, taking 26.7 months to approve a product. FDA Commissioner Margaret Hamburg suggested that implementing application fees would help the underfunded generics division expedite approvals.