FDA Recommends Three Drug User Fee Programs - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

FDA Recommends Three Drug User Fee Programs

ePT--the Electronic Newsletter of Pharmaceutical Technology

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and programs for human generic drugs and biosimilar biological products.

FDA modeled the proposed user fee programs on the PDUFA created by Congress in 1992. Commissioner Margaret A. Hamburg, PhD, stated in a FDA press release that the PDUFA has “ensured a predictable, consistent, and streamlined premarket program for prescription drugs.” Under the programs, the pharmaceutical industry helps to fund a portion of FDA’s drug review activities by paying fees. In return, FDA agrees to process applications in a particular timeframe as well as other performance goals.

Commissioner Hamburg stated, “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.” With the recommended programs, FDA would be able to continue to conduct timely reviews of critical prescription drugs, provide communication with small and emerging companies, promote the use of electronic data, and advance drug development for rare diseases.

The generic-drug market has been growing and applications for new generic drugs have been on the rise. FDA stated in the press release that the proposed Generic Drug User Fee program would ensure that the agency had the necessary funding to process new generic drug applications. The proposal includes review timeframes that would reduce the review backlog and provides a “commitment to achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year.”

FDA intends for fees included in the Biosimilar and Interchangeable Products User Fee program to generate revenue in the near-term and support development-phase meetings with sponsors. FDA stated that the proposed biosimilar program would spur competition in the biologic drug market by allowing companies to develop alternative products. According to FDA, a biosimilar is “a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biologic product and the reference product in terms of safety, purity, and potency of the product.”


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here