FDA to hold public meeting on its user fee programmes

Home/Policies & Legislation | Posted 05/06/2020 post-comment0 Post your comment

The US Food and Drug Administration (FDA) is to hold a virtual public meeting to discuss the financial transparency and efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA).

User Fee V13H23

The meeting will include presentations on the 5-year plans for the PDUFA VI, BsUFA II, and GDUFA II.

The PDUFA was originally passed in 1992 and enables FDA to collect fees from prescription drug manufacturers. Similarly, the GDUFA sets outs fees for companies that manufacture human generic drug products that are distributed in the US and was signed into law in 2012. The BsUFA does the same for biosimilar manufacturers. The Agency recently released new guidance on the BsUFA II, which outlines the removal of certain fees and extension of the Agency’s authority to collect fees from fiscal year (FY) 2018 through FY 2022 [1].

The online meeting will also respond to an independent third-party evaluation of the resource management associated with the Acts, which was published in 2019. This report presented an assessment of five key areas, including administration of the fee programme resources, user fee estimating methodology and resource planning.

It provided a number of recommendations for FDA including implementing a fully integrated User Fee Management policy, developing higher level strategic objectives that cut across all user fee programmes, and using new analytical approaches such as econometrics models. Progress towards these goals will be outlined at the meeting.

Each of the user fee programmes includes a set of commitments related to financial management, which include publishing a five-year financial plan that should be updated each year. The requirement to host a public meeting each fiscal year is also a commitment of the programmes.

Through the meeting, FDA will provide updates on the financial management of the programmes and present the five-year financial plans for each, including progress towards implementing resource capacity planning and modernizing its time reporting approach.

The meeting will take place virtually on 22 June 2020 from 9 a.m. to 11 a.m. Eastern time.

Interested parties can register, by 19 June 2020, at: https://www.eventbrite.com/e/public-meeting-financial-transparency-and-efficiency-of-user-fee-programs-registration-101672491158

Related articles
US FDA clears Biocon manufacturing sites in Malaysia and India

US policy to combat high-priced generics

FDA releases new information on interchangeable biologicals

1. GaBI Online - Generics and Biosimilars Initiative. FDA issues new guidance for biosimilar user fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Guidelines/FDA-issues-new-guidance-for-biosimilar-user-fees

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: Federal Register

comment icon Comments (0)
Post your comment
Related content
Panama embraces international pharmacovigilance standards
Pharmacovigilance V13F21
Home/Policies & Legislation Posted 09/07/2024
FDA proposal to remove biosimilar interchangeability status in FY25
01 AA007239
Home/Policies & Legislation Posted 12/06/2024
MHRA unveils strategy for regulating AI technologies
23 AA011020
Home/Policies & Legislation Posted 22/05/2024
Regulatory Certainty Strategy for biosimilars launched in Mexico
Home/Policies & Legislation Posted 09/04/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010