By Ryan Lesigues
The Anti Red Tape Authority (ARTA) had a meeting with the Food and Drug Administration (FDA) together with the compounders of Ivermectin and those who are advancing the use of the said drug to combat COVID-19.
This was meant to discuss the reason why the FDA is not approving Ivermectin for human consumption.
According to ARTA Director General Jeremiah Belgica, included in the discussion was the FDA’s recommendation to add Ivermectin in the Department of Health’s treatment protocol so that drug suppliers can submit applications for Drug for Emergency Use.
The supplier of Ivermectin can only apply for Drug for Emergency Use if it is included in the treatment protocol of COVID-19.
DG Domingo disclosed that “as of the moment application for Drug for Emergency Use is the most convenient option. However, this only applies for drugs that are included in the COVID-19 treatment protocol.”
ARTA is also scheduled to hold a meeting with the DOH. Recommendations will be made for all concerned agencies which will also be submitted to President Rodrigo Duterte.
In line with this, Belgica encouraged the private sector to apply for a permit to use Ivermectin.
“Let’s not let bureaucracy get in the way of people getting better services. Mag-apply ho kayo (Apply) and ARTA will hold your hand. We’ll make sure na walang panggigipit na magaganap (We’ll make sure that nothing will get in the way).”
ARTA also urged the FDA to expedite the processing of applicants to use Ivermectin.
“With this directive, FDA needs to be clear with their timelines and come up with a fixed list of requirements in accordance with their submitted Citizen’s Charter,” ARTA Director General Jeremiah Belgica said, noting that the regulatory body for food and drugs shall only take three working days to act on requests for CSPs based on its updated Citizen’s Charter.”
Under Republic Act 11032 or the Ease of Doing Business Law, all government processes must only run for three, seven, or 20 days depending on the transaction. Otherwise, ARTA may declare automatic approval of pending applications provided that submitted requirements are complete and fully paid for.
One of the promoters of the use of Ivermectin is Doctor Allan Landrito who started giving Ivermectin to his patients on July 2020.
Yesterday, Domingo warned the public against the use of Ivermectin because it is not FDA registered. The official explained that a person can have adverse effects on the brain if they take high doses of Ivermectin.
