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U.S. Department of Health and Human Services

Drugs

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April 4: Understanding the need for additional funding and a Generic Drug User Fee Amendments (GDUFA) system, do you have any concern that the projected fees as currently published will cause severe financial hardship to the small to mid-size generic companies? My fear is that the larger generic companies will eventually take over the industry, drive out the small guys, and increase drug prices.

CDER Director's Mailbag

This was a concern discussed by the pharmaceutical industry and FDA during the Generic Drug User Fee Amendments negotiations meetings. FDA and organizations that represent active pharmaceutical ingredient manufacturers discussed and agreed to a comprehensive compromise solution for many user fee concerns, including waivers and exemptions related to the proposed fees. FDA and the parties involved agreed that fee waivers and exemptions would not be included. This decision was reached after considering the relatively low amount of expected individual fees compared with the more efficient review times and inspections. FDA will also be able to hire additional science and inspection staff to handle adjudications which is expected to benefit and ease the administrative burden on small businesses.

FDA is committed to the success of small businesses and provides support to them directly through the Small Business Assistance program. You can learn more about the Small Business Assistance program at http://www.fda.gov/smallbusinessdrugs.

You can find more information about GDUFA at: www.fda.gov/gdufa. To sign up to receive e-mail updates about GDUFA, including any updates pertinent to small businesses, go to: https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_243. You can also send related questions to AskGDUFA@fda.hhs.gov.