Keeping science of medicine ‘apolitical’

Food and Drug Administration (FDA) director-general Dr. Eric Domingo could only wish this government regulatory agency would have all the legal flexibility to perform its mandate. When the coronavirus disease 2019 (COVID-19) pandemic first broke out in our country in March last year, Domingo recalled the many challenges the FDA had to adequately respond to the then brewing public health emergency crisis.

As the chief state regulator of products – eaten or used by Filipinos – the FDA passes upon food, drinks, pharmacological and even cosmetic products before they get to be registered and sold as safe and fit for human consumption. Only after going through the rigorous testing and examinations by the FDA experts, scientists and doctors can such products be given or issued with certificate of product registration (CPR) and be sold to the public.

Domingo went on to narrate how the less than a thousand personnel of FDA went through the tedious process of expediting the tests on new disinfectant liquids such as repurposed alcohol products; personal protective equipment (PPEs); disposable face masks; vitamin supplements; among other goods that went short of supplies at the height of the COVID pandemic scare.

The best argument on the need to empower the agency with greater flexibility, Domingo cited, was Executive Order (EO) 121. Signed on Dec. 2, 2019, President Rodrigo Duterte issued EO 121 “granting authority to the director general of the FDA to issue emergency use authorization (EUA) for COVID-19 drugs and vaccines.”

This was after the World Health Organization (WHO) allowed the issuance of EUA for drugs and vaccines even while still under phase 3 clinical trials. In a bid to contain the deadly COVID-19 contagion that was quickly spreading across the world, the WHO authorized the inoculation of people with these vaccines for as long as the FDA of their respective countries would likewise grant them with EUA.

Had the WHO not allowed EUA, Domingo pointed out, it might take until 2025 before people could be inoculated with potential immunity against the deadly COVID-19 infection. For one, it takes vaccine-makers seven years at the least to attain the safety and efficacy of their vaccine products, he cited. Thus, EUA is given only to those that hurdled human trials while the phase 4 as the last stage before product registration, he added.

Given the urgency presented by the COVID-19 pandemic, President Duterte mandated the FDA in EO 121 to complete its reglementary examination and testing of vaccine and drug products within a 21-day period. Under normal circumstances, Domingo noted, the shortest period is six months or more in the exercise of due diligence by the FDA in the examination of each and every product.

Despite the 21-day review period, the FDA chief pointed that the delays in EUA issuance are largely due to the applicant’s submission of vaccine evidentiary requirements. As of last Wednesday, when we had our Kapihan sa Manila Bay via zoom webinar, Domingo announced the FDA granted EUA to the anti-COVID vaccine made by American biotech firm, Moderna. Earlier, six other anti-COVID vaccines got EUA from the FDA, namely, Pfizer, AstraZeneca, Sinovac, Sputnik-V, Novavax, and Janssen.

Under its present charter, the FDA is among the attached agencies of the Department of Health (DOH). Domingo’s immediate superior is DOH Secretary Dr. Francisco Duque III who is the co-chairman of the anti-COVID responses of the government under the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-MEID).

At the Kapihan sa Manila Bay, Domingo underscored the need to strengthen the agency with such commensurate powers to immediately address looming or emerging public health emergency crisis, whether of epidemic or pandemic proportion. In fact, Domingo disclosed, there are a number of bills at the 18th Congress to amend the existing FDA law in the Philippines for this purpose.

As FDA director-general, Domingo conceded he could only do so much within the powers granted to him under its charter.

These bills proposed to amend the FDA charter under Republic Act No. (RA) 9711, otherwise known as the “Food and Drug Administration Act of 2009.” President Duterte and the present 18th Congress will bow out together from office in June next year. But this FDA bill is not included among the priority bills under the common legislative agenda submitted by the Duterte administration to the leaderships of both chambers. The FDA, Domingo admitted, has been strongly lobbying with the authors and sponsors of the proposed bills to push Congress for its speedy passage into law.

Amid this, the FDA has been under pressure by those pushing to allow Ivermectin, better known as anti-parasitic medicine, to be used for COVID treatment, or taken in as prophylaxis to fight COVID infection. Domingo clarified the Ivermectin, along with other investigational medicines Remdesivir and Avigan, are all currently issued by the FDA with “compassionate special permits” (CSP) only.

The FDA chief further stressed, these investigational medicines can only be prescribed by doctors at hospitals held accountable under the CSP and must report back to the agency the results of the treatment for proper monitoring. And, most especially, Domingo added, the patients are informed of the risks and agree to this treatment.

While waiting for completion of trials being done here on orders of the President, the FDA has granted CSP to six private hospitals for use of Ivermectin to treat mild and moderate COVID patients only.

While the FDA chief has this legislative agenda for his agency, Domingo though is not one to compromise with the political agenda of certain lawmakers openly pushing for Ivermectin. Hopefully, the majority of legislators realize the importance of the passage into law of this FDA bill. We certainly cannot afford another epidemic, or a new pandemic even – God forbid – strikes us again.

An eye cancer specialist, Dr. Domingo sees the science of medicine must remain “apolitical” as far as the FDA is concerned.