FDA questioned on sale of imported COVID-19 rapid test kits

Congressman Mike Defensor on Thursday questioned the Food and Drug Administration (FDA) for allegedly allowing the sale of different brands without first checking their effectiveness or if they are approved in their countries of origin. 

Defensor, who is the representative of Anakalusugan party-list, said he received numerous complaints about the alleged unreliability and inaccuracy of imported rapid kit brands.

“Masyadong maraming inaprubahan kahit walang permit [They approved many even without a permit]. FDA has no capacity to 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 kit brands even though these were not approved by FDA from their respective home countries,” he added.

Defensor added that nearly 50 percent of the 39 rapid kits approved by the FDA for use and distribution in the Philippines has “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.

The lawmaker pointed out that under FDA rules, rapid test kits may only be sold in the country if they were able to acquire “emergency use” approval from their respective regulatory agencies in their countries of origin.

Also read: India to supply Philippines affordable COVID-19 medicines

Defensor said the following are the 16 COVID-19 rapid test kit brands with no endorsements from regulatory bodies from their origin countries:

  •     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