31 March 2021 – Anti-Red Tape Authority (ARTA) Director General Jeremiah Belgica, in a meeting earlier, called on the Food and Drug Administration (FDA) to “keep their communications open for the registration of pharmaceutical companies who would want to apply for a Drug Emergency Use or a Compassionate Special Permit for Ivermectin”.
During the meeting, pharmaceutical stakeholders were given the option to apply to use the said drug under a Compassionate Special Permit for specific patients and institutional use. According to the FDA, the pharmaceutical stakeholders could also apply for a Certificate of Product Registration for the Ivermectin for its indicated use as an anti-parasitic drug but not as a COVID-19 treatment drug, the process of which will take 180 working days per the FDA’s Citizen’s Charter. In any case, the doctors and physicians shall take full responsibility for the use of the drug with their patients.
The ARTA chief appealed to pharmaceutical stakeholders who are pushing for the use Ivermectin to submit their applications. “Apply ho tayo. I do believe that not everyone is a fan of Ivermectin. But only those who want to try, we do invite you to test out our system. Tingnan ho natin kung ano pong mangyari”, Belgica told the pharmaceutical stakeholders. In this regard, he restated ARTA’s commitment to fulfill its part in ensuring that their applications will be acted upon within time frame indicated in the FDA’s Citizen’s Charter.
Belgica also reiterated his call to FDA Deputy Director General Oscar Gutierrez to assist the pharmaceutical companies who are compounding Ivermectin in complying with all the documentary requirements.
Department of Health Undersecretary Maria Rosario Vergeire who was present during the earlier part of the meeting said that while their recommendation on the use of the drug remains conditional, DOH remains open for further studies and trials regarding the use of Ivermectin. She also expressed that the agency is willing to work with the pharmaceutical groups in conducting said studies.
“Let’s have that meeting point where we will all work together kung talagang gusto natin itong gamot na ito [Ivermectin]. Your team and our team can work together so that we can get enough evidence, robust evidence para kung sakaling kailangan talagang gamitin ito”, said Undersecretary Vergeire.