Industry has reservations about possible user fees to support FDA's OTC drug monograph activities, but the agency is fairly adamant that the program needs greater funding, particularly if it moves forward with a potential overhaul of the system to improve its functioning.
'Real Challenge' To Improve OTC Monograph Program Without User Fees – FDA
FDA is weighing the potential benefits of, and drawbacks to, establishing user fees to support its OTC drug monograph program, opening a docket for comments and conducting a June 10 public meeting on the subject. Industry seems far from on board at present, and FDA also acknowledges that there could be downsides to a user fee program in addition to potential benefits for companies and consumers.
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