Pangilinan to FDA: Explain use of unlicensed logistics firm in return of 7,500 vaccine doses from Bicol

THE Food and Drug Administration (FDA) should explain how an unlicensed logistics company using defective thermometer was allowed to deliver AstraZeneca vaccines causing 7,500 doses to be returned to the Department of Health, Senator Francis "Kiko" Pangilinan said Friday.

Citing the law creating the FDA (Republic Act 3720) and the law strengthening and rationalizing its regulatory capacity (RA 9711), Pangilinan, who caused Senate Committee of the Whole hearings on the government's vaccine roll-out with his Senate Resolution 594 in December 2021, said the FDA authorizes logistics companies to transfer and distribute vaccines.

Section 11(k) of RA 3720, 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."

"Sabi ng DOH, ngayong raw, malamang na umabot na ng 700,000 Covid cases natin at 100,000 ang active cases. Tapos mababalitaan nating maaaring nasayang ang libo-libong doses ng bakuna dahil pinayagaan ang hindi lisensyadong logistics company ang mag deliver nito (According to the DOH, today our Covid cases is 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)," said Pangilinan.

"Kailangang may managot (Somebody should be accountable)," he said, noting that the law punishes violators with up to 10 years of prison time and up to five million pesos in fines.

On Wednesday (March 24), news reports said at least 7,500 doses of British-made AstraZeneca vaccines that were sent to Bicol for the region's health-care workers were sent back to the DOH office on Sunday (March 21) because these had been packed in containers with defective thermometers.

"Ang ibang bansa ay kontrolado na ang pandemya. Ang Taiwan, walang 1,000 ang Covid cases, di hihigit sa 10 ang namatay. (Other countries have been able to control the spread of Covid. Taiwan does not have 1,000 Covid cases and not 10 people have died due to the disease). Yesterday, a member of my staff lost his father due to Covid. They were unable to admit him in time because all nearby hospitals have reached maximum capacity," Pangilinan said.

"Yung kwento niya, kwento sa maraming bahagi ng bansa. Nawala ng magulang ang anak, nawalan ng anak ang magulang. Mga mahal sa buhay. Katrabaho. Kaibigan. (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.

After the Senate hearings were able to clarify the timelines and other performance indicators for the vaccine roll-out, Pangilinan reiterated that government must focus all its power and might on managing and controlling the spread of Covid.

Pangilinan noted that FDA, in line with its power to set standards, itself issued FDA Circular No. 2021-003 or the Revised Guidelines on the Cold Chain Management for Pharmaceutical Products and Establishments.

This circular sets 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 FDA and the IATF (Inter-Agency Task Force on Emerging Infectious Diseases) must determine if the logistics company involved committed acts in violation of Section 11 of RA 9711," Pangilinan said.

"The matter must be investigated and if warranted the logistics company be blacklisted," he added.