User Fees

HHS late Tuesday evening (Jan. 5) indicated it planned to exempt distilleries and other small businesses that supplied hand sanitizer during the COVID-19 public health emergency from FDA’s over-the-counter monograph user fee program.

FDA plans to reduce fees for its biosimilar product development (BPD) program in fiscal 2021 and to keep overall biosimilar user fee program and application fees at their fiscal 2020 levels, the agency announced Thursday (July 30).

Patient and consumer organizations want FDA to use funding from prescription drug user fees to develop educational materials for patients that explain off-label drug use.

A generic drug lobby official urged FDA officials to allocate more generic drug user fees toward improving the rate of first-cycle generic drug application approvals. Increasing first-cycle approvals could help increase the safety and availability of generic product, which could also facilitate access to more affordable drugs, the lobbyist said.

Even as FDA dedicates significant time and manpower to its COVID-19 response efforts, the agency continues to move forward on the new over-the-counter monograph regulatory and user fee framework, which was passed into law in late March.

The biosimilars industry and FDA will grapple with myriad regulatory shifts in 2020, with one of the most immediate challenges being the drug-to-biologic transition that some brand and generic drug makers will face next month.

The Senate passed over-the-counter (OTC) drug monograph reform legislation by a vote of 91-2 on Tuesday (Dec. 10), coming after the lower chamber’s counterpart bill, reintroduced over the summer, was added to the House GOP’s drug pricing legislation.

The Senate health committee will mark up over-the-counter drug monograph reform legislation along with seven other public health bills on Thursday (Oct. 31), according to an announcement from committee Chair Lamar Alexander (R-TN).

Acting FDA Commissioner Ned Sharpless told agency staff in an email Tuesday (July 23) that his top priorities are to develop frameworks for regulating new technologies; invest in the agency’s workforce; help to lower drug prices by encouraging drug competition; and improve postmarket surveillance of regulated products.