Solons want probe into DOH, FDA policies on registration, use of COVID-19 drugs

House Speaker Lord Allan Velasco and Deputy Speaker Bernadette Herrera-Dy have filed a resolution seeking an inquiry into the policies of the Department of Health and the Food and Drug Administration on the registration, utilization and manufacture and distribution of drugs for COVID-19.

Through House Resolution 1711, the two lawmakers urged the Committee on Good Government and Public Accountability to conduct an inquiry on the matter as well as the policies and guidelines of both agencies, which appear to be detrimental to public interest amid the pandemic.

The resolution specifically mentioned FDA Circular No. 2020-12 or the Guidelines for the Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019.

It stated that the said circular as well as other guidelines have been questioned for being "arbitrary, bureaucratic, and inhumane for causing unnecessary delays in the approval and clearance of drugs and therapeutics for emergency use authorization or for use of drugs under compassionate special permit against COVID-19."

In this time where there is no actual cure yet for COVID-19, the lawmakers said drug and medical experts have been coming up with a treatment protocol, including administration of certain drugs and therapeutics, which are allowed for use and treatment of COVID-19.

Herrera-Dy is among the lawmakers who are pushing for the use of anti-parasitic drug ivermectin as possible treatment for COVID-19.

Last week, the FDA granted a hospital’s application for "compassionate use" of ivermectin.

Despite the approval, the FDA said its distribution is still prohibited, saying only the hospital that has the permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

The World Health Organization (WHO), the US Food and Drug Administration, the European Medicines Agency (EMA) have all said there is currently a lack of data on ivermectin's efficacy and benefits as a COVID-19 treatment.

In its official statement, ivermectin manufacturer Merck said there is “no scientific basis for a potential therapeutic effect [from ivermectin] against COVID-19 from pre-clinical studies."

Merck also said there is "no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 and a concerning lack of safety data in the majority of studies."

"We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information," it continued.

Last week doctors debating the use of ivermectin acknowledged the lack of phase two trials on the appropriate dose of ivermectin, either to be given for patients who are being treated for COVID-19 or its use as prophylaxis.

Dr. Tess Lawrie, director of the UK's Evidence-Based Medicine Consultancy Ltd., urged the Philippines to do a study on ivermectin as a prophylaxis for health workers, saying that there were few serious adverse events (SAEs) recorded during studies on ivermectin as a COVID-19 treatment.

Dr. Jacinto Blas Mantaring III, who chairs the Department of Clinical Epidemiology of the University of the Philippines' College of Medicine, cited an international research initiative's ivermectin studies in cautioning that there could be as much chance that ivermectin causes harm as it could bring benefit to patients. 

Dr. Vicente Y. Belizario Jr., Dean of the UP College of Public Health, said there needs to be a consensus among doctors, as well as agencies such as the World Health Organization and the country's Food and Drug Administration, for its possible use against COVID-19. — BM, GMA News