30 March 2021 – The Anti-Red Tape Authority (ARTA) will discuss the possible inclusion of Ivermectin in the COVID-19 treatment protocol with the Department of Health (DOH) and the Food and Drug Administration (FDA) on its meeting with the said agencies tomorrow, Wednesday.
This, after FDA Director General Eric Domingo explained in a meeting earlier with ARTA Director General Jeremiah Belgica and the pharmaceutical stakeholders that an application for a Drug Emergency Use (DEU) would be the most plausible option for companies who intend to manufacture Ivermectin, an anti-parasitic drug undergoing trials for the possible treatment of COVID-19 symptoms. The said drug, however, must be included in the DOH’s treatment protocol first for it to be eligible for an application for DEU.
In response to the pharmaceutical groups and associations’ clamor to have Ivermectin made available for COVID-19 patients’ use, Domingo said that hospitals and doctors may use the drug under a Compassionate Special Permit (CSP) in the meantime. The application process for CSP shall only take 24 to 48 hours provided that all the requirements have been complied with. The FDA, however, has not received any of such application to date.
“If you file for an application for a CPR, then we promise we will prioritize it. Pwede niyo po kaming singilin kapag lumampas kami sa oras. Pag nag-apply for CSP or EUA, there will be a decision within the time frame but we cannot promise anything more than that. We cannot act on nothing. Kung wala naman pong naka-apply sa amin, wala naman po kaming pwede mailabas na pagpayag o pahintulot,” the FDA chief said.
In this regard, Belgica encourages the concerned stakeholders to comply with the applications necessary to be able to use the drug. ARTA will also ensure that all applications will be acted upon within the processing time. During the meeting, at least two pharmaceutical companies namely the Pascual Laboratories and the Lloyd Laboratories committed to apply for use of Ivermectin.
“Pag nakita ho natin na meron ho talagang deliberate attempt na hadlangan ang mga bagay na ito for no apparent reason, whether wittingly or by negligence, then that is already a matter suitable for the enforcement of ARTA law,” the ARTA czar warned.
ARTA also implored the FDA’s appropriate action on the case of a pharmaceutical company who reported to have been asked to discontinue the compounding of Ivermectin after being mistaken as a manufacturing company. It is also calling on other pharmaceutical companies who are encountering the same situation to coordinate with ARTA.
“Kung sila naman ay walang viniolate, buksan, hindi ko sinasabing gumawa ng regulasyon, hindi ho, ipatupad natin nang tama. Tulungan ho ninyo kung anong kailangan dahil ang gusto lang naman ng mga ito ay makatulong at makaligtas ng buhay,” Belgica said.
ARTA is now considering the formation of a special task force that would ensure the timely processing of all procurement, donations, and other logistical needs related to the government’s COVID-19 response action.
Philippine Chamber of Commerce and Industry (PCCI) Chairman Sergio Ortiz-Luis Jr. expressed his gratefulness for ARTA’s intervention in the Ivermectin issue: “We are so happy that ARTA came into the picture because everyday people are dying. Kargo de konsensya natin ‘yan. If this medicine is true, why are we delaying it considering the urgency and the safeness apparently of the Ivermectin”.
Present also in the meeting were representatives from the Philippine Chamber of Pharmaceutical Industries, Philippine Association of Pharmacists in the Pharmaceutical Industry, Philippine Association of Medical Device Regulatory Affairs Professionals, and the Pharmaceutical and Healthcare Association of the Philippines.