The Food and Drug Administration has completed recommendations for three user-fee programs that commissioner Margaret Hamburg said will expedite the introduction of generic drugs and biosimilars to the market.


Food and Drug Administration, drug user-fee programs, drug user fee, generic drugs, biosimilars, Margaret Hamburg, Kathleen Sebelius, generic medications, biological products, Prescription Drug User Fee Act, PDUFA, PDUFA V, PDUFA IV, Generic Drug User Fee Act, GDUFA, Generic Pharmaceutical Association, GPhA, Ralph Neas, Biosimilar and Interchangeable Products User Fee program, Biologics Price Competition and Innovation Act, BPCI








































































































































































































































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FDA finishes work on drug user-fee programs

January 16th, 2012

SILVER SPRING, Md. – The Food and Drug Administration has completed recommendations for three user-fee programs that commissioner Margaret Hamburg said will expedite the introduction of generic drugs and biosimilars to the market.

The FDA said the recommendations were transmitted to Congress on Friday by Health and Human Services (HHS) Department Secretary Kathleen Sebelius.

Work on the proposals was completed before the mid-January deadline, according to the FDA. Specifically, the programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA) plus new user-fee programs for generic medications and biosimilar biological products.

"At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion," Hamburg said in a statement.

"Human drug user fees have revolutionized the drug review process in the United States since they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency's high standards," she added.

The proposed user-fee programs for generics and biosimilars are modeled on the PDUFA program, which Hamburg stated "has ensured a predictable, consistent, and streamlined premarket program for prescription drugs." PDUFA must be reauthorized every five years, and the current program (PDUFA IV) is set expire on Sept. 30 unless reauthorized by Congress.

The FDA said its recommendations for PDUFA V were developed in consultation with drug industry representatives as well as with patient and consumer advocates. Under the recommendations, fees paid by industry would support continued timely review of critical prescription drugs plus advance the development of drugs for rare diseases, provide for enhanced communication with small or emerging companies, increase the use of standardized electronic data to improve quality and efficiency, and foster the use of new clinical endpoints that improve drug development times and help address unmet medical needs, according to the agency.

The FDA noted that the proposed new Generic Drug User Fee program would furnish it with the necessary funding at a time when generic drug applications are rising. Such medications account for two-thirds of all prescriptions dispensed in the United States.

On Friday, the Generic Pharmaceutical Association (GPhA) applauded the FDA for completing and submitting to Congress its recommendations for the proposed Generic Drug User Fee Act (GDUFA).

"This is an important landmark that could not have been achieved without the extraordinary efforts of the FDA, my colleagues in the generic industry and all other stakeholders," GPhA president and chief executive officer Ralph Neas said in a statement. "We now look forward to working with members of Congress in the weeks and months ahead to ensure that the final program is one that expedites access to low-cost, high-quality generic drugs for Americans and further safeguards the quality and accessibility of our nation's drug supply."

Each year, the FDA receives 800 to 900 new generics-related applications, which the agency said are increasingly complex and often involve products made outside the U.S. In exchange for fees on facilities and product applications, the proposal includes performance metrics such as review time frames and a commitment to achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year. The FDA said it expects the proposal to effectively eliminate the review backlog and slash review times.

The proposed Biosimilar and Interchangeable Products User Fee program, meanwhile, is intended for products approved under a new, abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological product. The Affordable Care Act of 2010 contains a subtitle called the Biologics Price Competition and Innovation Act (BPCI) of 2009, which established this pathway.

Before that became law, competition in the biologic drug market was "stifled," according to the FDA. "Enactment of BPCI will spark the development of a new segment of the industry, where companies will be able to develop alternative products. This will help spur innovation, improve consumer choice and drive down costs," the agency stated.

The recommended user fee program for biosimilars, the FDA said, includes fees for products in development to generate revenue in the near term and provide the agency with the necessary resources to support development-phase meetings with sponsors of biosimilar biological product candidates.

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