User Fees

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.

Seven major health organizations, including the Consumer Healthcare Products Association, Pew Charitable Trusts and American Academy of Pediatrics, are urging Congress to swiftly pass legislation that would reform the system under which over-the-counter (OTC) drugs are regulated and brought to market.

The House on Monday (July 16) passed an over-the-counter (OTC) monograph reform bill by voice vote that would amend FDA's OTC drug review process, set in place a user fee system known as OMUFA and grant 18 months of exclusivity to makers of innovative OTC drugs.

The House Energy & Commerce Committee on Wednesday (May 9) voted to send to the floor legislation that would reform FDA’s decades-old process for reviewing over-the-counter drugs, even as lawmakers continued to grapple with the 18-month period of exclusivity that the bill would grant to manufacturers of innovative OTC drugs.

A bipartisan group of House lawmakers hopes to add to the animal drug user fee package moving through Congress a measure that would expand the scope of FDA's animal drug conditional approval pathway so that it applies to large populations of animals.