President Duterte has authorized the Food and Drug Administration (FDA) to allow the emergency use of coronavirus vaccines and related treatments in the country.
He has issued Executive Order No. 121 granting authority to the FDA director general to issue an emergency use authorization (EUA) for drugs and vaccines that may prevent, diagnose, or treat coronavirus but with certain conditions.
The regulatory practice of EUA issuance aims to hasten the availability and use of coronavirus drugs and vaccines in the absence of available approved and adequate alternatives.
“It is a priority of the State to ensure that the lives of the Filipino people, especially the underprivileged, poor, and marginalized, our frontliners, healthcare providers, police officers and soldiers, and those in the essential services shall be protected from COVID-19 by ensuing accessibility and adequacy of supply of related drugs and vaccines,” Duterte said in the order.
The Health department had earlier asked the President to allow the FDA to grant EUA for coronavirus vaccines and drugs that will shorten the approval process to 21 days from usual six months. The emergency use authorization was sought following the recent breakthroughs in the vaccine development by foreign drug manufacturers.
Under the EO, the President set the following conditions for the issuance of EUA:
1. Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19;
2. The known and potential benefits of the drug or vaccine when used to diagnose, prevent, or treat COVID-19 outweighs the known and potential risks of the drug or vaccine, if any; and;
3. There is no adequate, approved, and available alternative to the drug or vaccine for COVID-19.
“Outside clinical trials and except in cases where a Compassionate Special Permit is issued, no unregistered COVID-19 drug and vaccine may be manufactured, sold, imported, exported, distributed, or transferred without an EUA,” Duterte said.
EO 121 also stated any application for EU must comply with “good manufacturing practices” and accompanied by an underlying by the manufacturer to complete the development of the drug and vaccine.
In evaluating EUA applications, the FDA director general will have the power to implement reliance and recognition process for the emergency use of drugs and vaccines.
“For this purpose, the FDA director general may accept the regulatory decision of the WHO (World Health Organization), US-CDC (United States Centers for Disease Control and Prevention), or other internationally recognized and established regulatory authorities,” Duterte said.
The President also allowed the FDA to convene a panel to conduct a review of data on the safety and efficacy of a COVID-19 drug or vaccine applied for an EUA. The panel will be composed of excerpts on drug and vaccine development.
“After the review, the panel shall submit to the FDA Director General its report and recommendations on the application for EUA.”
Any issuance of EUA will be valid only within the duration of the declared public health emergency due to the coronavirus. The FDA director general may revisit or revoke the EUA as appropriate to protect public health and safety.
The order also allowed the FDA to conduct “post-authorization monitoring” to track product deployment, additional relevant information, and the status from the manufacturer on the product’s life cycle.
“The holder of an EUA shall be required to complete specific pharmacovigilance obligations, with a view to providing comprehensive data confirming a positive benefit-risk balance.”
The FDA is also directed to submit to the President a monthly report on the implementation of the latest EO.
The order, signed by the President on Dec.1, takes effect upon publication in the Official Gazette or in a newspaper.