Drilon says administration of unauthorized Covid-19 vaccines ‘illegal’

Senate Minority Leader Franklin Drilon on Tuesday backed the position of the Food and Drug Administration (FDA) that without the proper authorization, the distribution and administration of unauthorized Sinopharm Covid-19 vaccine is illegal and punishable by law.

He also questioned how the China-made vaccines were able to get past the Bureau of Customs (BOC).

Citing the FDA Law or Republic Act No. 3720, as amended by Republic Act No. 9711, Drilon said the law prohibits the “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded or any health product which, although requiring registration, is not registered with the FDA pursuant to this Act.”

Section 21 of the same law provides that no person shall manufacture, sell, offer for the sale or transfer any new drug, unless an application filed containing full reports of investigations to show that such drug is safe, efficacious and of good quality for use based on clinical studies, prior to manufacture, sale, importation, exportation, distribution or transfer thereof.

Drilon pointed out that the administration of the unauthorized drug to some cabinet members and the military clearly violates FDA Circular No. 2020-036 or the “Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for Covid-19.”

The circular, which applies both to “pharmaceutical industry and government entities such as national procurer or health program implementors”, requires that an application for the issuance of an Emergency Use Authorization be filed and obtained from the FDA.

The Emergency Use Authorization is an authorization issued for unregistered drugs and vaccines in a public health emergency, upon demonstration of safety, effectiveness and quality.

The FDA made clear that it has not given any Emergency Use Authorization to any vaccine for Covid-19 amid revelation made by the President himself that some cabinet officials, soldiers and members his Presidential Security Group were inoculated with a China-made vaccine.

Drilon warned that any person who violates any of the provisions of Section 11 of RA 3720, as amended, faces a penalty of imprisonment ranging from 1 to 10 years or a fine of not less P50 thousand but not more half a million, or both.

The manufacturer, importer or distributor faces stiffer penalties of 5 to 10 years imprisonment and a fine of P500 thousand to P5 million, he warned.

An exception is if the pharmaceutical company and national procurer or health program implementor obtain the Emergency Use Authorization under the FDA Circular, he noted.

In this case, no Emergency Use Authorization was ever issued prior to the inoculation of the abeovementioned officials, he said.

Source: Latest Politics News Today (Politics.com.ph)