FDA Warns Florida Generic Maker for Late GDUFA Fees

October 10, 2014

The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees.

Florida-based ANDAPharm registered with the agency for fiscal 2013 and 2014, but has not paid facility fees for those two years as required under the Generic Drug User Fee Act (GDUFA), according to the agency’s warning letter released Tuesday.

The agency considers all of ANDAPharm’s products to be misbranded, and if the manufacturer doesn’t pay the requisite fees, the FDA could seize its products, says the letter issued Aug. 26.

GDUFA requires generic drug and active pharmaceutical ingredient makers to pay fees that are adjusted every fiscal year for each manufacturing facility. The fiscal 2015 facility fees are $247,717 for domestic manufacturers and $41,926 for domestic API facilities. Foreign drug manufacturers must pay $262,717 and API facilities $56,926.

The FDA has posted delinquent generic manufacturers on its website, and has warned 10 firms since June, mainly for not registering or failing to pay the facility fees.

ANDAPharm could not be reached for comment.

Don’t let GDUFA implementation negatively affect your company. Prepare yourself by registering for Impact of GDUFA Performance Metrics on ANDA Approval Times today!