The FDA is proposing changes to the Generic Drug User Fee program intended to streamline administration, improve review efficiency and set shorter review periods for priority submissions. Sen. Tom Cotton, R-Ark., is sponsoring a bill that would require the FDA to make a final approval decision within 150 days of receiving priority generic-drug applications.
The final guidance on generic-drug-maker controlled correspondence was issued by the FDA on Monday. It was issued to better clarify formal questions that are commonly raised before the generic-drug-review process. The guidance includes additional details about the data that can be included by generic-drug-makers in a controlled correspondence, as well as the information that will be provided by the FDA to requestors and what constitutes controlled correspondence for the purposes of the 2012 Generic Drug User Fee Act.
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.
The FDA issued a draft guideline for Generic Drug User Fee Amendments to the Prescription Drug User Fee Act. The agency's website features documents including guidance for generics-makers on self-identification of generic-drug sites, organizations and facilities, as well as questions and answers about the guideline. FDA officials and drugmakers are hoping that the amendments will guarantee faster review of generic-drug applications and reduce backlog.
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."