BAGUIO CITY – The Food and Drug Administration (FDA) chided the city government for allegedly aggressively promoting an antigen self-test kit that was not issued a special certificate as a self-test kit as of February 3, 2022 pursuant to the pertinent provisions of Republic Act (RA) 9711, otherwise known as the FDA Act of 2009.
FDA Director Maria Cecilia C. Matienza of the Center for Device Regulation, Radiation Health and Research stated that such use of the ICHROMA COVID-19 AG TEST is in alleged violation of the manufacturing, importation, exportation, sale, offering for sale, distribution and transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization of the FDA.
Further, the FDA issued FDA Advisory No. 2022-0022 dated January 20, 2022 to reiterate the warning for health care professionals and the general public not to purchase and use the COVID-19 test kits from unauthorized importers or distributors.
The FDA ordered the city government to delete the published Facebook posts regarding ICHROMA COVID-19 AG TEST as a self-test kit upon receipt of the communication dated March 8, 2022.
The FDA gave the city government three days to take action on this matter and that failure of the city to comply with the said requirement will result in the imposition of administrative penalties and sanctions against local officials and personnel of the local health department.
Upon the alleged prodding of Mayor Benjamin B. Magalong, the city government embarked on a week-long antigen self-test program in various district health centers around the city after the pilot simulation of the same in other health centers early January.
Magalong had been repeatedly announcing in previous interviews that self-test is done to immediately identify and isolate COVID-19 positive cases and that cases found out to be positive are considered laboratory confirmed even with or without clinical signs and symptoms.
The ICHROMA COVID-19 AG TEST self-test kits had been sold by the city government at P280 each for interested users.
The kit may be brought home by the residents and video instructions have been provided with printout instructions included in the said self-test kits.
On the other hand, health care workers in the district health centers were also tasked to swab the kit recipients.
Accomplished tests were handed over to the processing center within 2 hours with proper label and container and that the results may be given through a text message or printed out results.
The city was able to properly dispose of the bio-waste generated by the test that had been taken from the recipients of the same.
City and health officials had been negotiating for the most affordable price, so as to determine positive COVID-19 cases in the barangays as soon as possible to ensure that they will be immediately isolated from the healthy ones.