- On June 22, the FDA sent a warning letter to Vista Pharmaceuticals, which is based in India, for not paying Generic Drug User Fee Act (GDUFA) fees on time.
- This is the fourth time this month that the FDA has sent a warning letter to a generics company for failure to pay GDUFA fees.
- Under GDUFA provisions, generics manufacturers are supposed to pay different fees based on several factors, including where they are based (U.S. or abroad), the type of product being manufactured and whether the final product is a finished dosage form or an active pharmaceutical ingredient (API).
Failure to pay GDUFA fees is an international problem. This month alone, companies in India, the U.S. and China were fined for failure to pay in a timely manner. Apparently, this is part of a larger problem. Based on a list from July 17, there are currently a total of 26 GDUFA facilities that have been identified as being in arrears for at least one of the last three fiscal years.
Overall, Vista owes a total of $688,258 for the last three years. Failure to pay can result in a company having their products seized, as well as ANDA denials. In addition, their products may be placed on import alert and not allowed into the U.S. until the fees have been paid.
Some of the other companies that owe GDUFA fees inlcude Syntho Pharmaceuticals, in upstate New York, Wuxi Kali Pharmaceutical in China and Sharon Bio-Medicine, also in India.