AMID a strong reminder from the Department of Health and Food and Drug Administration (FDA) that only hospitals with compassionate special permit (CSP) may administer the controversial Ivermectin to Covid-19 patients, two lawmakers on Thursday distributed free tablets of the anti-parasitic drug in Quezon City.
At the launch of the “Ivermectin Pan-Three,” Anakalusugan Rep. Defensor together with Sagip Rep. Rodante Marcoleta distributed around 2,000 Ivermectin tablets to some 200 individuals in Barangay Matandang Balara in Quezon City.
He also said they will start house-to-house distribution of Ivermectin tablets on Friday or Saturday following several requests.
According to Defensor, they are not violating any law because the distribution complies with the regulations of the FDA and human-grade Ivermectin tablets are allowed with doctor’s prescription.
Defensor has said FDA Director Eric Domingo told lawmakers that licensed compounding pharmacies are allowed to compound Ivermectin, as long as it is made by a licensed compounding laboratory with a doctor’s prescription.
Defensor said people were required first to fill up a form before on site medical practioners prescribed them with the drug.
Earlier, Defensor warned
he would seek legal action against the FDA if it blocks the distribution of Ivermectin.
From the experts’ collective testimony, the lawmakers said, Ivermectin had been widely used to treat a variety of human parasites since its introduction in 1981 and since then, is being taken along with vitamins C and D, melatonin, zinc, among others, including steroids for the elderly and asthmatic patients.
They said Ivermectin has undergone invitro studies showing it effectively kills Covid-19 virus and was found to cure bacterial infection for pneumonia.
According to the FDA, the registered Ivermectin products in the country for human use are in topical formulations under prescription use only, and this is used to treat external parasites such as head lice and skin conditions such as rosacea.
The FDA said the registered oral and intravenous preparations of Ivermectin are veterinary products approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species.
It reiterated that Ivermectin is not approved by the FDA for treatment of any viral infection.
However, the FDA said five hospitals have already secured a CSP to use antiparasitic drug Ivermectin on its Covid-19 patients as of Tuesday, April 27.
DOJ: No position yet
Meanwhile, Secretary Menardo Guevarra deferred making a position on the legality of the two conditions issued by FDA that paved the way for the use and distribution of Ivermectin as treatment against Covid-19.
“The legal basis for the two exceptional situations is not clear,” Guevarra told reporters when asked whether distribution of a prohibited drug such as Ivermectin can be a basis of a warrantless arrest.
Under the FDA law, the importation, sale, distribution or administration of unregistered drugs or vaccines are prohibited and punishable.
Ivermectin, according to Guevarra, is not registered for use by humans because it is intended to treat animals with known parasitic diseases.
Apparently, Guevarra said the distribution of Ivermectin as possible treatment for Covid-19 violates the FDA law.
However, FDA had earlier announced that Ivermectin may be allowed in certain situations such as when it is covered by a compassionate use authorization issued to specific hospitals, doctors or other entities and when Ivermectin is compounded by duly licensed pharmacies and supported by a doctor’s prescription.
These exceptions bolstered Defensor’s and Marcoleta’s decision to push through with the distribution of Ivermectin to QC residents with prescription.
The DOJ also said he would not blame Defensor and Marcoleta from proceeding with the distribution of Ivermectin despite existing law prohibiting distribution of unregistered drugs.
“So, if Representative Defensor and Representative Marcoleta’s act of distributing Ivermectin would fall under any of these two situations, it would appear that they can put this up as a defense just in case a complaint is filed against them,” Guevarra said in a separate interview over ANC.
“But, personally I’m not too sure whether these two exemptions cited by the FDA director-general have a sound legal basis. So that is something that is for further study. I’m not too sure about the soundness of the legal basis for the exemptions,” Guevarra pointed out.
The legal implications of Defensor and Marcoleta’s action, according to Guevarra, may be realized at a future time.