GPhA Applauds Congressional Vote to Restore FDA Sequestered User Fees



WASHINGTON DC, (January 15, 2014) — Today, the U.S. House of Representatives voted to restore $85 million in Food and Drug Administration (FDA) sequestered user fees, reflecting bipartisan recognition of the critical need to ensure the agency has the resources required to carry out its mission, including the review and approval of affordable generic medicines.

“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,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA).

GPhA commends House Agriculture and FDA Appropriations Chairman Rep. Rob Aderholt, Ranking Member Rep. Sam Farr, and Reps. Leonard Lance and Anna Eshoo, as well as the leadership of Senate Agriculture and FDA Appropriations Subcommittee Chair Sen. Mark Pryor, and Ranking Member Sen. Roy Blunt, for recognizing the importance of restoring user fees. GPhA looks forward to prompt Senate approval in the coming days.

“Restoration of previously sequestered user fees, particularly those designated in accordance with the Generic Drug User Fee Act (GDUFA), and the Biosimilar User Fee Act (BsUFA), 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,” Neas said.

Indeed, generics saved the nation’s health system $217 billion in 2012 and $1.2 trillion over the most recent decade, according to the 2013 Generic Drug Savings in the U.S. report.

User fees expected from biosimilar product applications, paid for by manufacturers under the Biosimilar User Fee Act (BsUFA), will give 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, 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,” said Neas.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U -
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii |
Pharmacy Interior | Image Credit: Tyler Olson -
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi -
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen |
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/ |
Image credit: fidaolga -
Pharmacists checking inventory at hospital pharmacy- Image credit: Jacob Lund |
Young male pharmacist giving prescription medications to senior female customer in a pharmacy | Image Credit: Zamrznuti tonovi -
© 2023 MJH Life Sciences

All rights reserved.