FDA MONITORING ILLEGAL SALE OF COVID-19 TEST KITS

The Food and Drug Administration (FDA) is now engaged in “exhaustive monitoring” of online selling platforms to track the illegal sale of FDA-certified COVID-19 test kits.

In an advisory issued on March 4, the regulatory body said: “The FDA strongly reminds all concerned stakeholders and the general public that online selling of all types of FDA-certified COVID-19 test kits (reverse transcription-polymerase chain reaction or RT-PCR, antibody, antigen-based) is strictly prohibited.”

It reminded the public that these COVID-19 test kits with FDA special certification “are strictly for medical professional use and not intended for personal use.”

FDA Director General Eric Domingo ordered regional field offices and regulatory enforcement units to “conduct exhaustive monitoring” of Lazada and Shopee to determine if COVID-19 test kits were being peddled on these online selling platforms.

The FDA also said it would “implement immediate regulatory and enforcement actions as warranted” against violators of Republic Act No. 9711, or the Food and Drug Administration Act of 2009.

Since the outbreak of the pandemic last year, the government has gone after the illegal sale of COVID-19 test kits, which are supposed to be administered by a medical professional in screening for the new coronavirus.

In May 2020, the National Bureau of Investigation arrested a former actress and her mother for the illegal sale of COVID-19 rapid test kits worth P78,000.

The FDA has, however, issued as of February special certifications for a total of 380 COVID-19 test kits that are allowed for commercial use but under the supervision of a medical professional.

Of the number, 129 are RTPCR kits, 108 are rapid antibody kits, 68 are immunoassay kits, and 75 are other types of COVID-19 test kits.