The Food and Drug Administration (FDA) must explain why an “unlicensed” logistics company using a defective thermometer was allowed to deliver 7,500 doses of AstraZeneca vaccines, Senator Francis “Kiko” Pangilinan appealed on Friday, March 26.
Pangilinan lamented this after 7,500 COVID-19 vaccines sent to the Bicol region were returned to the Department of Health (DOH) in Manila.
“According to the DOH, today our COVID cases are most likely to breach 700,000 and the active cases, 100,000. Then we get reports that thousands of doses of vaccines may be lost because an unlicensed logistics company was allowed to deliver them,” he said in a statement.
Pangilinan pointed out that under Section 11(k) of RA 3720, or the law creating the FDA, as amended by RA 9711, prohibits: “The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, or retail of any drug, device or in-vitro diagnostic reagent; the manufacture, importation, exportation, transfer or distribution of any food, cosmetic or household/urban hazardous substance; or the operation of a radiation or pest control establishment by any natural or juridical person without the license to operate from the FDA required under this Act.”
He said the FDA and the Inter-Agency Task Force (IATF) on Emerging Infectious Diseases must probe the liability of the logistics company involved under the law.
“The matter must be investigated and if warranted the logistics company be blacklisted,” Pangilinan stressed.
“Kailangang may managot (Somebody should be held accountable),” he said, noting that the law punishes violators with up to 10 years of imprisonment and up to P5-million in fines.
Pangilinan said the FDA itself issued the Circular No. 2021-003 or the Revised Guidelines on the Cold Chain Management for Pharmaceutical Products and Establishments.
This circular, he said, has set the standards for, among other things, storage and transport of time and temperature-sensitive pharmaceutical products; checking the accuracy of temperature control and monitoring devices; qualification of refrigerated road vehicles; temperature-controlled transport operations by road and air; qualification of shipping containers; transport route profiling qualification; and temperature and humidity monitoring systems for transport operations.
The senator noted how other countries have been reporting how they managed to control the pandemic. Taiwan, he pointed out, has less than 1,000 COVID-19 cases and not even 10 people have died due to the disease.
“Yesterday, a member of my staff lost his father due to COVID-19. They were unable to admit him in time because all nearby hospitals have reached maximum capacity,” Pangilinan said.
“This is a story echoed in many places in the country. Where children lost their parents, and parents lost their children. Loved ones. Colleagues. Friends,” he added.
The DOH on Wednesday, however, assured that the vaccines that were returned “remain in usable condition.”
“We have yet to receive the official report on this but preliminary findings show that the temperature device was faulty and the vaccines remain in usable condition,” the DOH said in a statement.