WASHINGTON — The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.
“User fee programs are instrumental in the shared effort by FDA and the generic industry to help patients gain timely access to more affordable generic medicines and biosimilars,” stated Ralph Neas, president and CEO of the Generic Pharmaceutical Association. “Restoration of previously sequestered user fees, particularly those designated in accordance with the Generic Drug User Fee Act and the Biosimilar User Fee Act, is a necessary and commendable step. 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."
User fees expected from biosimilar product applications, paid for by manufacturers under the Biosimilar User Fee Act, will give the FDA the needed resources for timely review and feedback for companies developing biosimilar products, helping to speed biosimilars to market and give consumers a more affordable alternative to brand biologic medicines, GPhA stated.
“GPhA, its members and partners throughout the supply chain look forward to continued collaboration with the FDA. GPhA remains in full support of the application of industry-supplied user fees for safe and timely access to generics and biosimilars,” Neas said.