User Fees

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.

Like their colleagues in the Senate did last month, members of the House Energy & Commerce health subcommittee considered Wednesday (March 14) draft language to reauthorize the Animal Drug User Fee Agreement (ADUFA) and the Animal Generic Drug User Fee Agreement (AGDUFA).

Lawmakers may need to tweak provisions in the recently released over-the-counter monograph reform discussion draft that give FDA authority to issue administrative orders on packaging requirements for OTC drugs and to award two years of exclusivity to OTC drug manufacturers. FDA and stakeholders pointed to both provisions as issues that require a second look from Congress during the House Energy & Commerce health subcommittee’s Wednesday (Sept. 13) hearing on the bill.

House lawmakers released Monday (Sept. 11) a bipartisan discussion draft of their proposed over-the-counter monograph user fee program (OMUFA), coming two days ahead of an Energy & Commerce health subcommittee hearing on ways to reform the OTC monograph process.

President Donald Trump signed Friday (Aug. 18) the FDA Reauthorization Act of 2017, a White House spokesperson tells Inside Health Policy.

FDA will hold a public meeting Sept. 18 to examine the experiences of the agency and stakeholders with structured benefit-risk assessments and approaches to incorporating patient perspectives in these assessments, according to a Tuesday (Aug. 8) agency notice.

Public Citizen is claiming victory after Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ)'s Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, was not brought up as part of the FDA user fee package passed by the Senate Thursday (Aug. 3).