Controversy over FDA's Approval of Flowflex Test Kits 富樂快篩劑爭議 藍質疑EUA過程做手腳

The Kuomintang is calling on the Taiwan's Food and Drug Administration to explain why it granted EUAs to more than one suspect rapid test kit brand and to investigate importers' false advertising claims. 

This is a rapid test kit import permit that was issued by the Food and Drug Administration to Da Shin Co. on May 10. On the permit, it says the kits being imported were made in the U.S.. However, Dr. Shao Regulatory Consultants' EUA application is for kits made in China. The Kuomintang is demanding answers from the Ministry of Health and Welfare.

Lin Yi-hua, Legislator (KMT): “Dr. Shao also said a factory map was included in their application including the placement of doors. Dr. Shao also said the factory was located in China. Why is the FDA insisting (that the kits) were made in the U.S.?”

Tseng Ming-chung, KMT Caucus Whip: “A few days ago, Wu Shou-mei condemned these illegal acts and a government official said there would be an investigation. They're "guarding against gentlemen and not villains." What do we even have a Ministry of Health and Welfare for if it's going to be like this?”

In March, the U.S. Food and Drug Administration issued a warning saying Flowflex rapid test kits had not been authorized, cleared or approved by the FDA for distribution in the U.S.. In addition, the accuracy rate for Omicron was only 22.2 percent. The KMT therefore wants to know why Taiwan's FDA granted emergency use authorization to the manufacturer. In response, the Taiwan FDA said both Triple A Medtech and Da Shin's EUA applications were for test kits produced in San Diego and that's the product that was granted an EUA. The U.S. FDA also issued a warning against a South Korean rapid test kit around the same time that that was also later approved by Taiwan's FDA. The importer in Taiwan advertised the kit as approved by the U.S. FDA.

Lin Hsiu-teh, Section Chief, Medical Devices and Cosmetics Division, FDA: “Products that are approved in Taiwan aren't necessarily from the U.S.. These are two separate issues. The U.S. only announces whether a certain product is approved for use in the U.S. I checked and the (rapid test kits) in question were approved in Taiwan.”

Taiwan's FDA says the U.S. FDA's warnings address only EUA status and not safety or efficacy. It says it will investigate importers' advertising claims.

拿出食藥署5月10日發給大鑫公司的快篩試劑輸入許可證，但上頭的生產國別寫的卻是USA，與日前邵博士顧問公司所稱的申請快篩EUA都有標示中國製明顯不同，國民黨團上午再召開記者會，痛批該快篩EUA放行的過程被做了手腳，要求衛福部應該要出面說清楚。

國民黨立委林奕華表示：「邵博士也說了，他說在送件裡面檢附了全廠的廠區圖，也必須要有大門還有所有的位置，所以邵博士說有說地點在中國大陸，但是食藥署堅持說就是美國製。」

國民黨團總召曾銘宗表示：「吳秀梅前幾天講說，是不是應該要譴責非法廠商，甚至有官員說審核流程，很多時候都是防君子不防小人，那我們要問問衛福部，那我們要你們這些公務員做什麼。」

國民黨團表示，早在今年3月，美國FDA就警告富樂快篩沒有經過美FDA的核准，而且在測試Omicron病毒時，靈敏度只有22.2%，而且衛福部還是給核發EUA真的相當誇張，對此食藥署表示，不管是醫優還是大鑫公司，在送審EUA時檢附的資料都是美國製造，製造廠皆填寫聖地亞哥，因此食藥署通過審查時確認送審的產品與文件皆符合規範便核准EUA。就在富樂快篩案持續延燒的同時，目前食藥署許可的快篩中，另有一款韓製快篩，也曾在同一時間遭FDA警示，要求下架，進口商在宣傳時，卻還是以美國FDA批准做宣傳。

食藥署醫粧組科長林修德表示：「國內核准的產品不一定要美國上市，這是2件事情，美國那邊只是公佈說這樣子的產品，在美國國內是還沒被核准，我初步看就是國內的這個（快篩）產品在國內是有通過專案核准。」

食藥署表示，美國FDA的警示重點是該試劑尚未通過EUA，不得在美銷售，並沒有針對安全、有效性等進行評估，至於有廠商是否用美國FDA核准作為宣傳重點，還要進一步釐清。