A user-fee program intended to speed the approval of generic drugs is expected to begin Oct. 1 as planned even though Congress and the president failed to reach a spending agreement that reflected the new initiative.
Legislation passed in both the House and Senate before Congress adjourned until after the election would allow the Food and Drug Administration to begin collecting user fees from the generic drug industry next year. The bill, which the president is expected to sign, relieved the industry's concern that the program would be delayed because lawmakers resorted to another stopgap funding measure to fund the government.
As part of the reauthorizations of the pharmaceutical drug and device user-fee programs earlier this year, Congress authorized two new user-fee programs for the generic drug and biosimilar industries. As part of the user-fee agreement reached with the FDA, the generic drug industry is expected to pay $299 million each year to help fund generic drug approvals and facility inspections.