Solon scores FDA for allowing sales of dubious COVID-19 Test Kits

House Committee on Public Accounts chair Rep. Mike Defensor scored the Food and Drug Administration (FDA) for allowing the sale of more than a dozen brands of COVID-19 rapid test kits without proper validation.

 

The lawmaker said he has been receiving complaints about the unreliability and inaccuracy of a number of RTK (rapid test kit) brands. 

 

“Masyadong maraming inaprubahan kahit walang permit sa country of origin na mga rapid test kits (Too many rapid test kits were approved without a permit from their country of origin). FDA has no capacity to test the reliability of RTK so it has to depend on its counterparts from overseas,” said Defensor.

 

He wanted FDA Director-General Rolando Enrique Domingo and FDA Director Bayani San Juan to explain the approval of the questionable RTK brands. 

 

Defensor said nearly half of the 39 RTKs approved by FDA for use and distribution in the Philippines have a high rate of inaccuracy.

 

He accused the FDA of relaxing its rules for eight Chinese-made RTK brands that were not endorsed by the National Medical Products Administration because of a letter of inclusion from the Therapeutic Goods Administration (TGA) of Australia.

 

The lawmaker also said 16 RTKs approved by FDA were not endorsed by regulators in their home countries. They are:

 

1) Onsite COVID-19 by CTK Biotech made in USA (manufactured in China) no EUA FROM US FDA

2) Qingdao Hightop Biotech

3) Diagnosure COVID-19 by Hangzhou Biotest Biotech

4) Bioscience Chongqing

5) Zybio Inc.

6) Zheijang Orient Gene Biotech

7) Maglumi 2019 NCOs by Shenzen New Industries Biomedical

8) VivaDiag by Vivachek Biotech Hangzhou

9) Shanghai Outdo Biotech

10) Beijing Lepu Medical Technology

11) Hecin Scientific Inc.

12) Shanghai Kehua Bio-Engineering

13) Medical System Biotechnology Co.

14) Clongene by Hangzhou Clongene Biotech co.

15) Wantai Sars-Cov by Beijing Wantai Biological

16) Hangzhou Alltest Biotech Co. Ltd

 

Only five Chinese RTK brands were approved by both the NMPA and FDA:

 

1) Guangzhou Wondfo

2) Innovita Biological Technology Co. Ltd.

3) Guangdong Hecin

4) Vazyme Biotech Co. Ltd.

5) Zhuhai Livzon Diagnostics Ltd.

 

The FDA approves RTKs for sale in the country if they get so-called “emergency use” approval from their respective regulatory agencies in their countries of origin. An American brand for example needs approval from the United States FDA and a Chinese brand from the National Medical Products Administration before the FDA approves them for sale here.

 

The regulatory body has also approved for sale products that were previously cleared by authorities in South Korea, Singapore and Australia.

 

“Mass testing is crucial in determining how many people among the population have antibodies. RTKs are meant to augment the PCR (polymerase chain reaction test) test through sampling of population with or without illness to determine how many in the community have been exposed. It is important that the FDA regulate the RTK brands sold in the market to ensure equality and protect corporations and individuals using these products,” Defensor said.

 

The Department of Health has opposed the use of most antibody tests and maintains that the PCR test is the gold standard.