A party-list lawmaker on Thursday questioned the action of the Food and Drug Administration to allow the sale of more than a dozen brands of rapid test kits without validating first their effectivity or requiring that these be approved by regulators from their respective countries of origin.
Anakalusugan party-list Rep. Mike Defensor disclosed this, citing mounting complaints reaching his office about the unreliability and inaccuracy of a number of RTK brands which has added more fuel to the Department of Health’s opposition to the use of these antibody tests.
Defensor, vice chair of the House committee on health, also urged DOH Undersecretary and FDA Director-General Rolando Enrique Domingo and FDA Director Bayani C. San Juan to explain their alleged indiscriminate approval of RTK brands that gave these alternative COVID tests a bad name among the public.
“FDA has no capacity to test the reliability of RTK so it has to depend on its counterparts from overseas. The problem is it approved the sale of RTK brands even though these were not approved by FDA from their respective home countries,” said Defensor.
Defensor, chair of the House committee on public accounts, said nearly half of the 39 RTKs approved by FDA for use and distributions in the Philippines have dubious potency.
“Mass testing is crucial in determining how many people among the population have antibodies. RTKs are meant to augment the PCR test (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 RTK brands sold in the market to ensure equality and protect corporations and individuals using these products,” the lawmaker added.
Under FDA rules, RTKs can be sold in the country if these brands get “emergency use” approval from their respective regulatory agencies in their home countries such as an American brand from the United States FDA and a Chinese brand from the National Medical Products Administration (NMPA), China’s FDA.
FDA also allows provisional authorities and emergency use approval from South Korea, Singapore and Australia.
Defensor, however, noted that 16 RTKs approved by FDA were not endorsed by regulators in their home countries. He claimed the regulatory body also relaxed its rules for eight Chinese-made RTKs that were not endorsed by NMPA but were still allowed to sell by virtue of a Therapeutic Good Administration letter of inclusion from Australia.
The 16 RTK brands with no endorsements from the regulatory bodies intheir countries of origin are: 1) Onsite COVID-19 by CTK Biotech made in USA (Manufactured in China but 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 and 16) Hangzhou Alltest Biotech Co. Ltd.
Defensor said China was the biggest producer of PCR test kits and RTKs in the world and it should have based its approval on recommendations by NMPA whcih has endorsed only 23 firms that can export their products.
Of these NMPA-endorsed firms, five Chinese RTKs were accredited by FDA: 1) Guangzhou Wondfo; 2) Innovita Biological Technology Co. Ltd.; 3) Guangdong Hecin; 4) Vazyme Biotech Co. Ltd. and 5) Zhuhai Livzon Diagnostics Ltd.