The Chinese Nationalist Party (KMT) caucus yesterday demanded that Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the Central Epidemic Command Center, and Food and Drug Administration (FDA) Director-General Wu Shou-mei (吳秀梅) resign over flawed COVID-19 rapid test kits that entered the commercial market.
Flowflex COVID-19 Antigen Home Tests imported by Safeway OA Supply Co Ltd (大鑫資訊) were recalled on Wednesday, as the importer allegedly illegally purchased subpar kits from China and sold them as US-made products.
KMT caucus whip William Tseng (曾銘宗) at a news conference yesterday said that he noticed “red flags” regarding the Flowflex test kit after they were granted an emergency use authorization (EUA) on May 10 by the FDA.
Photo: Fang Pin-chao, Taipei Times
Tseng’s first concern was that the FDA did not revoke Flowflex’s EUA after Triple A MedTech (醫優科技) issued a statement on May 12 to warn the public about counterfeit Flowflex test kits being sold, he said.
The second concern was that Safeway OA is mainly a seller of ink cartridges, with no background in medicine and only NT$5 million (US$168,237) of capital, he said, adding that the company was approved to sell 240 million test kits with total worth of NT$24 billion.
The FDA apparently did not review the application, and that external forces might have been involved given that administrative procedures did not seem to have been followed, Tseng said.
KMT Legislator Alex Fai (費鴻泰) questioned the role that Dr Shao MD Regulatory Consultants Co Ltd played in the EUA approval, as cited by Triple A MedTech.
One of the company’s managers was “an FDA reviewer,” its Web site said, raising questions about whether approval was facilitated by an internal connection with the FDA, Fai said.
The KMT caucus asked the FDA to disclose how many former reviewers might be working for the company.
Premier Su Tseng-chang (蘇貞昌) yesterday said that the claims would be investigated.
Additional reporting by Wang Shan-yen
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