FDA Recommends Three Drug User Fee Programs - Pharmaceutical Technology

Latest Issue
PharmTech

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.”

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
28%
Oversee medical treatment of patients in the US.
9%
Provide treatment for patients globally.
9%
All of the above.
41%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here