2012 Prescription Drug User Fees Announced - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

2012 Prescription Drug User Fees Announced


ePT--the Electronic Newsletter of Pharmaceutical Technology

In late July, FDA announced the 2012 user fees collected under the Prescription Drug User Fee Act (PDUFA) of 2007. The act stipulates that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of three categories: applications for approval of drug and biological products, establishments where the products are made, and drug and biological products. In some instances, the fees can be waived, reduced, or refunded, as spelled out in an FDA draft guidance issued in March 2011.

The fees are calculated using the fee base revenue amount for fiscal year (FY) 2008 published in the Federal Register of Oct. 12, 2007 (72 FR 58103) adjusted for the FY 2009, FY 2010, FY 2011, and FY 2012 drug-safety increases, for inflation, for workload, for excess collections through FY 2011, and for a final-year adjustment. Rates for 2011 and 2012 are listed below:

  • For applications requiring clinical data, the FY 2011 fees were $1,542,000. FY 2012 fees will be $1,841,500, a 19.42% increase.
  • For applications that do not require clinical data, the FY 2011 fees were $771,000. FY 2012 fees will be $920,750, a 19.42% increase.
  • For supplements requiring clinical data, the FY 2011 fees were $771,000. FY 2012 fees will be $920,750, a 19.42% increase.
  • Establishment fees for FY 2011 were $497,200. FY 2012 fees will be $520,100, a 4.6% increase.
  • Product fees for FY 2011 were $86.520. FY 2012 fees will be $98,970, a 14.3% increase.

These fees are effective on Oct. 1, 2011, and will remain in effect through Sept. 30, 2012.



For related stories see:

FDA Issues Draft Guidance on User-Fee Waivers, Reductions, and Refunds

FDA Holds Public Meeting on Prescription Drug User Fee Act

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.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
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