Industry Gears up for GDUFA

PharmTech's columnist Jill Wechsler has written extensively about regulatory issues in the US. One of the latest regulatory developments is that generic-drug manufacturers are preparing to pay fees to FDA for the first time in the agency’s history. Application fees are already required from manufacturers when seeking regulatory approval from FDA for new prescription products, but this is the first time that such fees will also be collected from generic-drug manufacturers. The Generic Drug User Fees Amendments of 2012 (GDUFA) are scheduled to come into force in the US on October 1 2012 and will require drug manufacturers to pay annual facility fees and fees when submitting Abbreviated New Drug Applications (ANDAs) and drug maser files to FDA for generic drugs. A one-time fee will also apply to backlog applications as of 1 October.

The Growing Generic Burden

GDUFA was signed into law on July 9, 2012, with the aim of speeding access to safe and effective generic drugs to the public and reduce costs to industry. The program is based on an agreement negotiated between FDA and generic-drug industry representatives to address the regulatory challenges associated with the growing number of applications for generic drugs submitted to FDA.

According to FDA, around 78% of new and refilled outpatient prescriptions in the US were for generic drugs in 2011. More than 8000 generic drugs are currently approved in the US and FDA is receiving a growing number of applications for such products. Annually, the agency receives 800 to 900 generic-drug related applications—many of which involve products manufactured outside of the US. Due to limited resources, FDA has not been able to keep pace with the increasing volume of applications, resulting in a backlog of more than 2500 applications.

The fees will be used to fund more resources and staffing at FDA. By the fifth year of the program, FDA aims to be capable of reviewing and acting on 90% of completed generic-drug applications within 10 months of the submission date. In addition, FDA will increase its regulatory inspections of both foreign and domestic generic-drug manufacturing facilities. Currently, the agency only has the resources to conduct inspections outside of the US every 7 to 13 years.

GDUFA will also help boost the transparency of the generic-drug manufacturing industry by establishing an identification system requiring all facilities involved in the manufacture of generic drugs and their ingredients to register.

During the 5-year period from fiscal year 2013 through to 2017, the program is expected to provide FDA with approximately $299 million each year.

Read more about GDUFA in these related articles:

Articles from our Regulatory Watch columnist Jill Wechsler

Generic Drug User Fees Mark a Step in the Right Direction

Enactment of FDA Reform Act Improves Drug Safety

Generic-Drug and Biosimilar-User Fees Gain Traction

GPhA Urges Congress to Move Ahead on Generic-Drug and Biosimilar User Fees

Congress Passes Generic Drug Act

More information about GDUFA is also available on FDA’s website.

Fact Sheet: New User Fees for Generic Drugs Will Enhance Americans’ Access to Less Expensive Drugs and Generate Major Cost Savings

FDA completes work on three drug user fee programs

Guidance for Industry: Generic Drug User Fee Amendments of 2012: Questions and Answers

FDA Generics Guidance