BY GERARD NAVAL and WENDELL VIGILIA
ON the eve of the launch of the “Ivermectin Pan-three” project, the Department of Health and the Food and Drug Administration yesterday issued different statements as to the legality of the distribution of the anti-parasitic drug to COVID-19 patients.
Health Undersecretary Maria Rosario Vergeire said only hospitals which have been issued a compassionate special permit (CSP) by the FDA are allowed to use and distribute the drug.
Only five hospitals have so far been given the special permit.
“The only ones that can use ivermectin are those hospitals issued CSP. Aside from them, no others can distribute ivermectin since it is not yet registered in the country,” said Vergeire in a virtual press briefing.
FDA Director General Eric Domingo said physicians who will be present at the distribution event in Quezon City today may issue prescriptions to patients.
“For private physicians and doctors, they can prescribe it to patients, and they can get the drug from compounding pharmacies that are licensed by the FDA,” said in an online interview.
He said a list of licensed compounding pharmacies are available at the FDA website.
The distribution event is a project of two party-list representatives — Michael Defensor of Anakalusugan and Rodante Marcoleta of SAGIP.
Defensor said the project is “legally compliant” and vowed to legally challenge the FDA if it will stop the distribution of ivermectin.
“If they (FDA) will again stop this initiative, I will fight them in court because legally, compliant kami (we’re legally compliant),” he said.
The mass distribution of the anti-parasitic drug is being questioned by some sectors as ivermectin has not yet been approved as a COVID-19 treatment by the DOH, FDA, or even the World Health Organization (WHO).
The FDA Act of 2009 prohibits the manufacture, importation, export, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded.
The WHO last month recommended against using ivermectin for COVID-19 patients except for clinical trials, because of a lack of data to show its benefits. The US Food and Drug Administration and the European Medicines Agency have also warned against the use of the drug.
According to Vergeire, experts are insisting there is “very low quality of evidence” internationally that ivermectin can help COVID-19 patients who have mild to moderate symptoms.
Domingo, asked if the FDA is softening its stand against ivermectin due to political pressure, said, “We are not pro- or anti- ivermectin. We are just following the law, rules, and regulations of the FDA.”
The Department of Science and Technology is set to conduct clinical trials for ivermectin as COVID-19 treatment, on the order of President Duterte.
Defensor and Marcoleta said they will not be violating the law because aside from hospitals which have been granted CSPs, those who want to take ivermectin can acquire it through licensed compounding laboratories and pharmacies like Lifecore Bio-Integrative Inc. for as long as it has doctor’s prescription.
Also involved in the project are the groups Concerned Doctors and Citizens-PH, and Malayang Quezon City.
Marcoleta on Tuesday said ivermectin tablets will be provided by Lifecore, a licensed compounding laboratory, while doctors’ prescriptions will be given to patients.
The event will be held at the Matandang Balara Barangay Hall park at 9 a.m.
Marcoleta and Defensor said yesterday the pandemic is “technically a war that needs to be decisively confronted.”
“In war, people protect themselves with anything in order to survive. We need to cross the line and break the glass ceilings, if we must, one way or the other. We cannot, in good conscience, sit idly by at the excuse of inflexible bureaucracy to deny our people, especially the underprivileged, their pharmaceutically-assisted moments as they struggle to breathe their last,” they said in a statement.
Defensor and Marcoleta said that despite the declared policy to protect and promote the people’s right to health, “we observed the complacency, if not indifference, of DOH and FDA officials in regard to the potential use of ivermectin as a preventive drug or early treatment for COVID-19 patients.”
“Time and again, they are dismissive of the avalanche of clinical trials that have unfolded before their very eyes, unyielding to bend and improvise the guidelines and policies that apply only during normal times. The have stonewalled and become too unwilling to compromise and be flexible in the face of the great necessity to save lives,” they said.
In the joint hearings of the House committees on health and on good government, the lawmakers said, they intently listened to the opinions of medical professionals including Dr. Allan Landrito and Dr. Homer Lim who have administered ivermectin to some 8,000 patients, and claimed the patients’ condition all improved with 90 percent of them not needing to hospital admission.
