Defensor to FDA: Explain ‘indiscriminate’ approval of some rapid test kit brands

MANILA, Philippines — Anakalusugan Partylist Rep. Mike Defensor is seeking an explanation from the Food and Drug Administration (FDA) over the “indiscriminate approval” of several coronavirus disease 2019 (COVID-19) rapid test kit (RTK) brands despite not being endorsed in their home countries.

Defensor made the remark after receiving complaints about the “unreliability and inaccuracy” of several RTK brands being sold which, he said, have added to the opposition of the health department to use the antibody tests.

The lawmaker asked the FDA why it has allowed the sale of the RTKs in question without validating first their effectiveness or requiring that these be first approved by regulators from their respective countries of origin.

Specifically, Defensor sought the explanation of DOH Undersecretary and FDA Director-General Rolando Enrique Domingo as well as FDA Director Bayani C. San Juan.

“FDA has no capacity to test the reliability of RTK so it has to depend on its counterparts from overseas,” Defensor said in a statement.

“The problem is it approved the sale of RTK brands even though these were not approved by FDA from their respective home countries,” he added.

Under FDA rules, RTKs can be sold in the Philippines if these brands get “emergency use” approval from their respective regulatory agencies back in their home countries.

However, Defensor said that the 16 RTKs approved by the FDA were not endorsed by regulators in their home countries.

According to Defensor, these RTKs were not endorsed by regulators in their home countries:

Onsite COVID-19 by CTK Biotech made in USA (manufactured in China)
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

Further, Defensor also claimed that the FDA “relaxed” its rules for eight Chinese-made RTKs that were not endorsed by the National Medical Products Administration (NMPA)—FDA’s counterpart in China—but were still allowed to be sold by virtue of a Therapeutic Good Administration (TGA) letter of inclusion from Australia.

“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,” Defensor 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.

As of June 11, there are 23,732 COVID-19 cases in the country, with the death toll at 1,027 and recoveries at 4,895.

/MUF