FDA warns vs importation of COVID products

MANILA, Philippines — The Food and Drug Administration (FDA) yesterday warned against the importation of coronavirus disease 2019 (COVID-19) health products without prior approval and certification from the agency.

FDA director general Eric Domingo said the Bureau of Customs (BOC) would not release test kits for commercial use that did not go through the agency’s approval process.

“Businessmen should not import these products before they are certified by the FDA. An application for product certification of a diagnostic kit is not equal to an approval to sell or distribute,” Domingo said.

The FDA has approved only Real Time Polymerase Chain Reaction (RT-PCR) test kits for commercial use.

The Department of Health (DOH) only recommends the use of RT-PCR since there is still no clear evidence to support the use of point of care tests or rapid test kits in COVID-19 diagnosis.

“The FDA continuously reviews all applications on COVID-19 test kits and expedites processes. We are streamlining the procedures to efficiently facilitate COVID-associated health commodities,” Domingo said.

But he stressed that the FDA would not compromise the quality and safety of kits by approving those without scientific evidence and proper documentary basis.

He said the FDA does not require clearance of foreign-donated COVID-9 health products prior to customs release.

The DOH had already received 108,000 donated test kits from Korea, China and Singapore, he added.

Domingo assured the public that the FDA is maximizing all measures to combat the COVID-19 pandemic.

‘Sluggish COVID  testing’

In a related development, Sen. Sherwin Gatchalian has expressed disappointment over what he calls the “sluggish COVID-19 testing capacity” of the DOH.

Gatchalian said the department has yet to accredit any hospital to carry out COVID-19 testing even after pronouncements by the FDA that the newly delivered test kits from South Korea and China are now available for commercial use.

Marikina Mayor Marcelino Teodoro has also expressed frustration that up to this time his city cannot use its Molecular Laboratory and procure test kits as the DOH has yet to certify the local laboratory.

The Inter-Agency Task Force for the Management of Emerging Infectious Diseases said all LGUs must coordinate with the DOH before acquiring, purchasing or utilizing testing kits within their respective territorial jurisdictions.

The UP-National Institutes of Health, the Philippine Genome Center and manufacturer The Manila HealthTek Inc. are working to meet the government’s order of 26,000 testing kits.

Sen. Panfilo Lacson said while the COVID-19 curve seems to have been flattened a little with the lockdown implementation in the entire Luzon, the government still needs to conduct mass testing to effectively contain the spread of the virus.

Lacson questioned the BOC’s failure to release hundreds of thousands of rapid test kits to be donated by some local businessmen.