A Taiwan FDA plant inspector has been charged with taking more than $150,000 in bribes to pass on info on upcoming pharmaceutical inspections to Chinese drugmakers. The yearlong probe by Taiwan's Agency Against Corruption has also swept up the inspector's wife and executives and owners of 8 drug companies believed to have made payoffs in a scheme that some believe is much more widespread.
According to the Taipei Times, 50-year-old Chen Wen-hsiung, his wife and the other suspects were released on bond after being arrested and questioned about the alleged bribes. The newspaper said that Chen allegedly made at least NT$5 million ($157,878) in the past two years by letting drug companies know about the time and date of "unannounced" FDA inspections and also providing GMP certifications for products.
The Republic of China anticorruption agency was tipped off by the FDA, and Chen was put under surveillance for more than a year. He was seen allegedly taking bribes in coffee shops, and his wife is accused of depositing the money in a number of different banks. It said that investigators have ordered searches of the inspector's office and locations in Taoyuan, Tainan and Kaohsiung, the China Post reports.
Eva Teng, a spokeswoman with the National Health Insurance Civic Surveillance Alliance, told the Taipei Times that it is believed the corruption probably widespread. "It would seem incredulous for just one FDA inspector to able to shield the companies from proper checks and monitoring," she said. "The scandal clearly shows poor management and negligence by the FDA."
The arrests come shortly after Taiwan issued sanctions against Y.F. Chemical, which was ordered to pull all sodium chloride solution products and keep production shut after contamination was found to have resulted in adverse reactions in at least a dozen patients. Y.F. Chemical was not among companies the newspapers said are being investigated. The U.S. FDA has found issues with Taiwan companies as well, having issued a warning letter against an API maker who kept no records of its batch testing.
Only domestic companies have been named in the Taiwan scheme, unlike the bribery charges that swept up GlaxoSmithKline ($GSK) two years ago on mainland China. In that case, GSK paid about $500 million in fines to resolve charges that it has paid bribes to doctors and other healthcare officials to buy its products. Other Western drugmakers were also questioned, but no other charges were announced.