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Solon questions FDA for allowing sale of COVID-19 rapid test kit brands unsanctioned by their home countries
By ERWIN COLCOL, GMA News Anakalusugan party-list Representative Mike Defensor on Thursday questioned the Food and Drug Administration (FDA) for allegedly allowing the sale of various brands of rapid test kits for COVID-19 without first validating their effectivity or requiring them to be approved by regulators from their countries of origin.
In a statement, Defensor said he received numerous complaints about the supposed unreliability and inaccuracy of these rapid test kit brands.
"Masyadong maraming inaprubahan kahit walang permit. FDA has no capacity to test the reliability of rapid test kits so it has to depend on its counterparts from overseas," he said.
"The problem is it (FDA) approved the sale of rapid test kit brands even though these were not approved by FDA from their respective home countries," he added.
According to Defensor, nearly half of the 39 rapid test kits approved by the FDA for use and distribution in the country have "dubious potency."
"Mass testing is crucial in determining how many people among the population have antibodies. Rapid test kits are meant to augment the PCR (polymerase chain reaction) test through sampling of population with or without illness to determine how many in the community have been exposed," he said.
"It is important that the FDA regulate the rapid test kit brands sold in the market to ensure equality and protect corporations and individuals using these products," he added.
Defensor pointed out that under FDA rules, rapid test kits may be sold in the country if these brands get "emergency use" approval from their respective regulatory agencies in their countries of origin, like the United States FDA for American brands and the National Medical Products Administration (NMPA) for brands coming from China.
The FDA also allows provisional authorities and emergency use approval from South Korea, Singapore, and Australia, he added.
However, 16 rapid test kit brands approved by the FDA have no endorsement from regulators in their home countries, Defensor said.
He claimed that the FDA also relaxed its rules for eight Chinese-made rapid test kits not endorsed by the NMPA but were still allowed to sell through the Therapeutic Good Administration letter of inclusion from Australia.
The following are the 16 rapid test kit brands with no endorsements from regulatory bodies from their origin countries, according to Defensor:
- Onsite COVID-19 by CTK Biotech made in USA (manufactured in china) no EUA FROM US FDA
- Qingdao Hightop Biotech
- Diagnosure COVID-19 by Hangzhou Biotest Biotech
- Bioscience Chongqing
- Zybio Inc.
- Zheijang Orient Gene Biotech
- Maglumi 2019 NCOs by Shenzen New Industries Biomedical
- VivaDiag by Vivachek Biotech Hangzhou
- Shanghai Outdo Biotech
- Beijing Lepu Medical Technology
- Hecin Scientific Inc.
- Shanghai Kehua Bio-Engineering
- Medical System Biotechnology Co.
- Clongene by Hangzhou Clongene Biotech Co.
- Wantai Sars-Cov by Beijing Wantai Biological
- Hangzhou Alltest Biotech Co. Ltd
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China, which is the biggest producer of PCR test kits as well as rapid test kits, should have based its approval from NMPA recommendations, Defensor said.
He said the NMPA only endorsed 23 firms that can export their products, of which only five brands were accredited by the FDA:
- Guangzhou Wondfo
- Innovita Biological Technology Co. Ltd.
- Guangdong Hecin
- Vazyme Biotech Co. Ltd.
- Zhuhai Livzon Diagnostics Ltd.
Defensor urged Health Undersecretary and FDA Director-General Eric Domingo and FDA Director Bayani San Juan to explain their "indiscriminate" approval of rapid test kit brands.—AOL, GMA News