The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Generic Drug User Fee Act (GDUFA) performance goals and ways to improve procedures, ahead of negotiations to reauthorize the law.
The GDUFA calls for the generics industry to pay fees annually to FDA in the same way as brand-name drugmakers do [1]. This funding is supplemental to what the US Congress appropriates to FDA each year and is hoped will enable FDA’s Office of Generic Drugs to reduce its current backlog of pending applications, cut the average time required to review generics applications for safety and increase risk-based inspections [2]. The GDUFA lasts for a five-year period. The latest version will expire on 30 September 2017.
In a Federal Register notice published on 21 April 2014 FDA announced that it will hold a public meeting on 5 June 2015 at the agency’s White Oak Campus, New Hampshire, USA to discuss the GDUFA.
During a similar hearing in September 2014, drugmakers listed a series of shortfalls in the generics approval process, including the need for an overhaul of the inactive drug ingredients database to facilitate the filing of generics applications.
At the meeting in June 2015, FDA is seeking input from a variety of stakeholders, including industry, academia, patient advocates and professional societies, and is in particular interested in responses to the following questions:
- What is your assessment of the overall performance of the GDUFA program[me] to date?
- What aspects of the GDUFA should be retained, changed, or discontinued to further strengthen and improve the program[me]?
Requests to make oral presentations and comments at the meeting must be submitted by 15 May 2015. Electronic and written comments will be accepted until 26 June 2015. Persons interested in participating in the meeting should register by 15 May 2015.
FDA is also soliciting comments from the public, including industry, consumers, patient groups, caregivers and healthcare professionals, on five draft guidance documents related to the implementation of the GDUFA [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Generic and biosimilar user fee recommendations sent to Congress [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 8]. Available from: www.gabionline.net/Generics/News/Generic-and-biosimilar-user-fee-recommendations-sent-to-Congress
2. GaBI Online - Generics and Biosimilars Initiative. Generic drug user fees come into effect [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 8]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect
3. GaBI Online - Generics and Biosimilars Initiative. FDA calls for comment on generics user fees guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 8]. Available from: www.gabionline.net/Guidelines/FDA-calls-for-comment-on-generics-user-fees-guidelines
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Source: FDA, US Federal Register
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