SENATE Minority Leader Franklin Drilon 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, and 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 of 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.
However, no Emergency Use Authorization was ever issued prior to the inoculation of the abeovementioned officials, he said.
Drilon pointed out that FDA repeatedly said that “it is illegal to import an unregistered drug, to distribute it, and for a doctor or a medical practitioner or any health personnel to administer unlicensed drugs in the country”.
Drilon said that the inoculation of some cabinet officials and members of the Armed Forces of the Philippines (AFP) “set a bad example” and “undermined the very purpose of the creation of the FDA which is to “protect and promote the right to health of the Filipino people” and to ensure the “purity, safety, efficacy and quality of drugs and vaccines in the country”.
“What was done completely dismissed the well-entrenched public safety and health protocols. It further undermined the regulatory authority of the FDA with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products,” Drilon said.
He said the Filipino people should hope that what transpired will not influence the FDA’s decision-making process in issuing an Emergency Use Authorization to unregistered vaccines, including the China-made vaccines.
“As government officials, our priority is the safety of our people. That is the very purpose of FDA authorization- to make sure that the vaccines that we administer to our people are safe, effective and of certain quality”, Drilon emphasized.
“We, the leaders, should only obtain, approve and administer vaccines to our people which we, ourselves, will use,” he added.
Drilon also said the FDA can issue cease and desist orders motu proprio or upon verified complaint for health products, whether or not registered with the FDA.
“I hope this does not give us a glimpse of how they intend to implement the biggest vaccine drive in Philippine history. Otherwise, we are doomed,” Drilon said. “I hope that when the government’s Covid-19 vaccination program starts – with FDA-authorized vaccines- front-line healthcare workers and the poor should be given priority. Let the front-line doctors and nurses get the first and limited shots. No one should cut in line,” he stressed.
The minority leader also questioned how an unregistered Covid-119 vaccine passed through customs without the Bureau of Customs knowing it.
“How did it get past the BOC? Were the vaccines smuggled at the ports?” he asked.
Earlier, Drilon said public confidence is critical to the successful inoculation of our people, which can be achieved by adhering to a science-based process and the opinion of vaccine expert panel.
“The last thing we want to see is people scrambling for vaccine shots or refusing inoculation out of fear that the vaccine may be substandard,” he added.Publication Source : People's Journal