‘Dubious potency’: Defensor accuses FDA of flooding marker with ‘unsanctioned’ COVID rapid test kits

By JOHN CARLO M. CAHINHINAN

A official of the House of Representatives has accused the Department of Health (DOH) of sabotaging the COVID-19 test kits after the Food and Drug Administration (FDA) has allowed the sale of more than a dozen brands of rapid test kits that have not been sanctioned by any world governing bodies.

House committee on public accounts chair Mike Defensor has raised concerns after the FDA allowed the rapid test kits (RTK) in the market without validating first their effectiveness or requiring that these be approved by regulators from their respective countries of origin.

Defensor, representative of Anakalusugan Party-list, is seeking an explanation from Health Undersecretary and FDA Director-General Rolando Enrique Domingo as well FDA Director Bayani San Juan over their alleged “indiscriminate approval of RTK brands that gave these alternative COVID tests a bad name among the public.”

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

He stressed that he has been receiving complaints about the unreliability and inaccuracy of a number of RTK brands which added more fuel to the Department of Health’s opposition to the use of these antibody tests.

“Masyadong maraming inaprubahan Kahit walang permit day 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,” said Defensor.

According to Defensor, nearly half of the 39 RTK brands approved by FDA for use and distributions in the Philippines have “dubious potency.”

“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.”

Under FDA guidelines, 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)—Beijing’s FDA counterpart.

Defensor also noted that local FDA also allows provisional authorities and emergency use approval from South Korea, Singapore and Australia.

However, about 16 RTK brands approved by the local FDA “were not endorsed by regulators in their home countries,” according to Defensor.

The lawmaker also claimed that 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.

The 16 RTK brands with no endorsements from the regulatory bodies in their countries of origin include:

· Onsite COVID-19 by CTK Biotech made in USA (Manufactured in China but 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

· Hangzhou Alltest Biotech Co. Ltd

Defensor explained that Beijing’s NMPA has endorsed only 23 firms that can export their products.

Of these NMPA-endorsed firms, only five Chinese RTK brands were accredited by FDA and these are:

· Guangzhou Wondfo

· Innovita Biological Technology Co. Ltd.

· Guangdong Hecin

· Vazyme Biotech Co. Ltd.

· Zhuhai Livzon Diagnostics Ltd.

Source: Latest Politics News Today (Politics.com.ph)