Defensor calls out FDA on sale of rapid test kits
Published Jun 10, 2020 12:00 am
By Ben Rosario
The Food and Drug Administration (FDA) has come under fire for allegedly allowing the sale of over a dozen brands of rapid test kits without requiring approval of the imports by their respective countries of origin.
Anakalusugan Partylist Rep. Mike Defensor said the FDA has also allowed the sale of the brands without validating the effectivity of the kits.
Anakalusugan partylist Rep. Michael Defensor (AnaKalusugan partylist Rep. Michael Defensor Official Facebook Page / FILE PHOTO / MANILA BULLETIN)
Defensor, chairman of the House Committee on Public Accounts, said that he has been receiving complaints about the “unreliability and inaccuracy” of several RTK brands that has further fueled opposition of the Department of Health to the use of these antibody tests for COVID 19.
Defensor asked DOH Undersecretary and FDA Director-General Rolando Enrique Domingo and FDA Director Bayani C. San Juan to explain why RTK brands have been approved.
He noted that the FDA approval of questioned RTK brands had put alternative COVID-19 tests in bad light and eroded public confidence on them.
“FDA has no capacity to test the reliability of RTK so it has to depend on its counterparts from overseas,” said Defensor.
The senior administration lawmaker said that despite this weakness, the FDA still approved many RTKs without approval of its counterparts from the country of origin.
Defensor 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.
He also warned that inaccurate RTKs would only put in grave danger the population.
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 (TGA) letter of inclusion from Australia.
Defensor asked FDA to thoroughly examine endorsement of contries of origin of the RTK sourced from the following: 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 Biologicaland 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: Guangzhou Wondfo, Innovita Biological Technology Co. Ltd.,Guangdong Hecin, Vazyme Biotech Co. Ltd. and Zhuhai Livzon Diagnostics Ltd.
Anakalusugan partylist Rep. Michael Defensor (AnaKalusugan partylist Rep. Michael Defensor Official Facebook Page / FILE PHOTO / MANILA BULLETIN)
Defensor, chairman of the House Committee on Public Accounts, said that he has been receiving complaints about the “unreliability and inaccuracy” of several RTK brands that has further fueled opposition of the Department of Health to the use of these antibody tests for COVID 19.
Defensor asked DOH Undersecretary and FDA Director-General Rolando Enrique Domingo and FDA Director Bayani C. San Juan to explain why RTK brands have been approved.
He noted that the FDA approval of questioned RTK brands had put alternative COVID-19 tests in bad light and eroded public confidence on them.
“FDA has no capacity to test the reliability of RTK so it has to depend on its counterparts from overseas,” said Defensor.
The senior administration lawmaker said that despite this weakness, the FDA still approved many RTKs without approval of its counterparts from the country of origin.
Defensor 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.
He also warned that inaccurate RTKs would only put in grave danger the population.
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 (TGA) letter of inclusion from Australia.
Defensor asked FDA to thoroughly examine endorsement of contries of origin of the RTK sourced from the following: 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 Biologicaland 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: Guangzhou Wondfo, Innovita Biological Technology Co. Ltd.,Guangdong Hecin, Vazyme Biotech Co. Ltd. and Zhuhai Livzon Diagnostics Ltd.