Combined FDA And PDUFA Reform Mooted

At hearings of the US Senate Labor and Human Resources Committeeearlier this month, its chairman, Senator James Jeffords (Republican, Vermont), said he aims to introduce legislation which combines both Food and Drug Administration reform and reauthorization of the Prescription Drug User Fee Act in early May. He told FDA lead Deputy Commissioner Michael Friedman that the committee wants the agency to have the necessary resources for modernization, and urged it to present ideas for a bill before April, when the next round of hearings is scheduled.

Under existing PDUFA legislation, which expires September 30, user fee revenues have been used to hire additional staff for the FDA to speed up safety and efficacy reviews of New Drug Applications. According to the Nonprescription Drug Manufacturers Association's NDMA Newsletter, the current law specifies that fees cannot be assessed in a given year unless appropriations for FDA salaries and expenses increased by at least the amount needed to account for inflation.

Factory Inspections To Be Extended To OTCs? Sen Jeffords also asked Dr Friedman if it was true the FDA intended to extend factory inspection of prescription drugs to over-the-counter medicines and, if it did, to explain the benefits of such a move, and what new personnel would be needed.