Another Generics Maker Warned for Skipping GDUFA Fees
The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years.
The June 22 letter marks the fourth time in a month that the agency has chided a drugmaker for not paying the fees on time. Syntho Pharmaceuticals of Farmingdale, N.Y., Sharon Bio-Medicine of Dehradun, Uttarakhand in India, and Wuxi Kaili Pharmaceutical of Yixing City, Jiangsu in China also received GDUFA warning letters in June.
Nalgonda District, Andhra Pradesh, India-based Vista and the other three firms join 26 other GDUFA facilities cited by the FDA as being in arrears for at least one of the last three fiscal years, according to a July 17 updated 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.
As a foreign FDF manufacturer, Vista owes a total of $688,258 for the past three years — $190,389 for FY 2013, $235,152 for FY 2014 and $262,717 for FY 2015. The payments were due at the start of each fiscal year.
Companies that fail to pay their GDUFA fees risk having their products seized and ANDAs denied. Foreign scofflaws also risk being placed on import alert, with products denied entry into the U.S. As of the July 17 list, Syntho, Sharon and Wuxi Kaili still owed payment.
Vista did not return a request for comment by press time. To view the updated arrears list, go to www.fdanews.com/07-22-15-ArrearsList.pdf. The warning letter is at www.fdanews.com/07-22-15-Vista.pdf. — Kellen Owings