Manila Bulletin - 2021-05-05


FDA cannot assure safety of products given compassionate permit – Domingo



The Food and Drug Administration (FDA) on Tuesday, May 4, said it cannot assure the safety and quality of the products used under the condition of a Compassionate Special Permit (CSP) as it did not undergo evaluation by the agency. FDA Director General Eric Domingo said an unregistered drug, medical device, or food product used under the condition of a CSP does not undergo evaluation by the FDA. “So when we give a compassionate special permit it is very clear that we have no assurance of safety, efficacy, and quality because it did not undergo evaluation with the FDA,” Domingo said in virtual press briefing. President Duterte was vaccinated against the coronavirus disease (COVID19) using China manufactured Sinopharm vaccine in Malacañang on Monday evening, May 3. Health Secretary Francisco Duque III administered the vaccine to the President. Presidential spokesman Harry Roque said the dose used on the President was covered by the CSP issued to the PSG hospital by the FDA for the use of the 10,000 donated Sinopharm vaccines. This was confirmed by Domingo in a text message to Manila Bulletin saying: “Yes, it was part of the PSG vaccines with CSP.” He noted that the CSP holder “takes full responsibility for the product,” adding that the PSG applied for a CSP in February “because they found it necessary to vaccinate the close-in security of the President.” “The PSG hospital takes full responsibility for it,” Domingo said. “So it is not anything like an emergency use evaluation or a certificate of product registration because it did go through FDA scrutiny.” While there were three parties who expressed their intent to apply for an EUA, Domingo said the applicants have yet to submit the documents needed for an EUA application. “So wala pa tayong inievaluate na Sinopharm application at this time (So we have not evaluated a Sinopharm application at this time), he said. The FDA granted a CSP for 10,000 doses of Sinopharm vaccine for the use of PSG members in February.



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