Earlier this summer, James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics in the Department of Pharmaceutical Sciences (PSC) at the University of Maryland School of Pharmacy, joined representatives from across academia, government, and industry at the Food and Drug Administration (FDA) to testify for the renewal of the Generic Drug User Fee Amendments of 2012 (GDUFA).
Designed to provide the public with speedier access to safe and effective generic drugs and reduce the costs associated with developing those drugs, GDUFA was passed into law under the FDA Safety and Innovation Act in 2012. It requires generic drug manufacturers to pay fees that the FDA uses to supplement the costs of reviewing generic drug applications and inspecting manufacturing facilities. In addition to helping the FDA decrease the amount of time needed to review pending generic drug applications, those fees also help to support research aimed at improving generic drugs and the processes used to develop and approve those drugs.
The legislation is scheduled to expire at the end of September 2017.
“In the nearly four years since the legislation was passed, GDUFA funding has already demonstrated a clear impact, elucidating how medicines — including complex formulations — can be tested to assure quality,” says Polli. “Schools of pharmacy across the United States, including the University of Maryland School of Pharmacy, as well as industrial laboratories have received funding from GDUFA, which they have used to answer many questions aimed at assuring the quality of medications available to the public. Contributing laboratories such as those directed by myself and fellow PSC faculty members Drs. Stephen Hoag, Audra Stinchcomb, and Hazem Hassan continue to do tremendous work with this funding.”
To gain stakeholders’ initial feedback about the legislation, the FDA hosted a kickoff meeting in June. The agency invited representatives from academia, industry, patient and consumer advocacy groups, and health care organizations to provide their input and offer recommendations on the reauthorization of GDUFA, including assessing the overall performance of the GDUFA program to date and suggesting aspects of GDUFA that should be retained, changed, or discontinued to further strengthen and improve the program.
During his presentation to the agency, Polli offered an academic perspective on the impact of GDUFA-funded research across both academia and industry. He spoke about several ongoing GDUFA-funded projects at the School of Pharmacy and other universities across the country, including a groundbreaking study comparing bioequivalence between a major brand name and generic anti-epileptic drug for which he served as the principal investigator, in an effort to illustrate the importance of ensuring that any reauthorization of GDUFA includes continued funding for generic drug research.
“Perhaps the greatest aspect of GDUFA-funded studies is that they are able to spur additional generic drug research that might not necessarily be supported by GDUFA,” says Polli. “This legislation is able to fund exploratory studies that can later be picked up by other funding sources, including industry or another government organization. The work is being amplified by others committed to the same goal of improving generic drugs and the processes used to develop them. It is making a remarkable impact.”
Additional presentations highlighted other aspects related to the legislation, including communication regarding a drug’s application status after approval, the quality of generic drug applications, and the financial resources available for a new user fee agreement. The FDA will review the information from all presentations delivered during the meeting before moving forward with its own suggestions concerning the reauthorization of GDUFA.