A House leader questioned the use of rapid test kits without validation of its effectivity or approval from the regulators of the countries where they came from.
Chairman of the House committee on public accounts and Anakaluugan Rep. Mike Defensor said the Food and Drug Administration has allowed 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.
Defensor said he has been receiving mounting complaints about the unreliability and inaccuracy of a number of RTK brands which has added fuel to the Department of Health's opposition to the use of these antibody tests.
The solon said Health Undersecretary and FDA Director-General Rolando Enrique Domingo and FDA Director Bayani C. San Juan should explain their indiscriminate approval of RTK brands that gave the alternative COVID tests a bad name among the public.
"Masyadong maraming inaprubahan kahit walang permit from the country of origin na mga rapid test kits. 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," Defensor said.
Defensor noted that nearly half of the 39 RTKs approved by FDA for use and distribution 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.
According to Defensor there are 16 RTKs approved by FDA but were not endorsed by regulators in their home countries.
These are 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; and Hangzhou Alltest Biotech Co. Ltd.
He claimed the FDA 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 (TGA) letter of inclusion from Australia.