FDA Tightens Screws on GDUFA Fee Scofflaws

July 13, 2015

The FDA has warned three generics makers for failing to pay GDUFA fees during the last three fiscal years.

The companies —Syntho Pharmaceuticals of Farmingdale, N.Y., Sharon Bio-Medicine of Dehradun, Uttarakhand in India, and Wuxi Kaili Pharmaceutical of Yixing City, Jiangsu in China — join 31 other companies the FDA has cited as being in arrears for at least one of the last three fiscal years, according to a July 7 updated arrears list.  

Under the 2012 Generic Drug User Fee Act, firms owe different fees depending on whether they are U.S. or foreign-based and what type of product they manufacture, either finished dosage form or active pharmaceutical ingredient.

Syntho and Sharon owe $643,258 and $688,258, respectively, for the three years, while Wuxi Kaili, an active pharmaceutical ingredient maker, owes $147,899.

Failure to pay means all products manufactured at the facilities are subject to seizure or injunction, the FDA notes in near-identical June 22 warning letters. Appearing on the arrears list also means ANDAs will be automatically denied. The foreign facilities also risk being placed on import alert, denying product entry into the U.S.

The three firms did not respond to a request for comment by press time.

To view the July 7 arrears list, go to www.fdanews.com/07-08-15-ArrearsList.pdf. The Syntho, Sharon Bio-Medicine and Wuxi Kaili warning letters are available at www.fdanews.com/07-08-15-Syntho.pdf, www.fdanews.com/07-08-15-Sharon.pdf, www.fdanews.com/07-08-15-WuxiKaili.pdf, respectively. — Kellen Owings