Restored User Fees Bring Hope of Rapid Approvals

A US House of Representatives vote to restore $85 million in sequestered funds to the FDA brings the hope of speeding up the approval process for brand name, generic, and biologic medications.

The funds, originally obtained through the Prescription Drug User Fee Act, are normally collected when manufacturers submit a new brand name, generic, or biosimilar medication to the FDA for approval. The fees are used to hasten the approval of brand name medications, biosimilar products, and generic medications, and were initially sequestered by the Office of Management and Budget in 2013.

Industry organizations supporting pharmaceutical manufacturers, generic pharmaceutical manufacturers, and biologic product manufacturers lauded the bill’s approval, noting the negative impact resulting from the sequestered fees.

“User fee programs are instrumental in the shared effort by FDA and the generic industry to help patients gain timely access to medicines and biosimilars,” Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association (GPhA), said in a press release.

“Through this agreement, the House and Senate recognize the importance of restoring FDA access to the portion of user fees denied them under sequester,” Biotechnology Industry Organization President and CEO Jim Greenwood said in a release.

“Unfortunately, the sequester restricted FDA’s ability to access the full amount of all of their user fees, including the user fees our companies pay to provide resources for expeditious review of new drug applications ... It makes no sense to subject private company-paid user fees to sequestration,” he added. “... Instead, the only real effect is ... inhibiting the ability of the agency to fulfill its mission of ensuring patient access to safe, effective new drugs and biologics.”

The restoration of $85 million will be combined with approximately $2.6 billion in discretionary funding, for a total of $4.4 billion in federal funding for the FDA in 2014. The amount is a $91 million increase over the funds the agency received in 2013, according to the bill text.

The Senate Appropriations Committee filed a sister bill supporting the user fee restoration. That bill was approved 2 days after the House of Representatives’ bill and also restored the $85 million in prescription drug user fees.

GPhA commended representatives on the House Agriculture and Appropriations Committee and on the Senate Agriculture and Appropriations Subcommittee who would have directly dealt with FDA funding and the user fee sequestration.

“Restoration of previously sequestered user fees, particularly those designated in accordance with the Generic Drug User Fee Act (GDUFA), and the Biosimilars User Fee Act (BsUFA), is a necessary and commendable step,” Neas said in the release. “Now, agency experts can get back to business, expediting site inspections and enhancing the generic drug application and review process to ensure that savings from generic medicines are realized by patients, government, businesses, and others.”

Fees from the biosimilar applications are expected to provide the FDA with the resources needed to review and provide feedback to biosimilar developers in a timely manner, GPhA stated.

The bill is part of a larger bill omnibus combining 11 additional funding measures, and it specifies the federal government’s discretionary funding for the 2014 fiscal year. The bill is now awaiting the president’s signature.