- The Food and Drug Administration has banned imports from four Indian and Chinese generic drugmakers over a failure to pay user fees, reports Regulatory Focus. The firms had been warned but failed to comply with U.S. regulations.
- The Generic Drug User Fee Amendment (GDUFA), passed by Congress in 2012, was set up to facilitate faster review and approval of generic drugs by assessing fees for any company that submits generic drug applications to the FDA.
- Non-compliance with GDUFA can result in an import ban. In 2016, the annual facilities fee for foreign finished dose facilities is set at $285,905, according to Regulatory Focus.
Two of the banned companies, Jiangsu ZW Pharmaceuticals and Wuxi Kaili Pharmaceutical Company, are based in China, while the Fleming Laboratories and Sharon Bio-Medicine are both Indian firms. All four companies received warning letters in 2014 and 2015, and but failed to comply in time.
Although most of the importation bans imposed on facilities in India and China (as well as other markets) are related to quality-control issues, GDUFA non-compliance is now attracting FDA attention.
The four companies are the first firms to be banned from exporting drugs to the U.S. under GDUFA. Manufacturing violations, by comparison, have led to bans for 52 Chinese drugmakers and 43 Indian firms.