Lawmakers are insisting on the use of Ivermectin for treating and preventing novel coronavirus disease (COVID-19) even as health experts and regulatory agencies do not recommend it for lack of data on its efficacy in fighting the virus.
Anakalusugan Party-list Mike Defensor on Tuesday, April 6, expressed confidence that there will be no legal implications in his plan to give Quezon City residents the doses of the anti-parasitic drug, which some groups claimed can help cure or prevent COVID-19.
He said he will prioritize senior citizens and persons with comorbidities in the distribution of free Ivermectin capsules, which will be formulated thru a compounding pharmacy licensed by the Food and Drug Administration (FDA).
“Pinayagan na ng FDA to produce so legally allowed siya (The FDA has allowed its production so it is legally allowed),” Defensor told reporters.
“If no ban [was] given to compounding pharma[cies] they may continue to do so as long as there is prescription from a doctor,” Bagong Henerasyon Party-list Rep. Bernadette Herrera-Dy also said, disclosing to reporters she, too, requested for prescription from her doctor to be able to take Ivermectin.
Compounding is the process of mixing or altering drug ingredients to create a medication specific to a patient. Those who wanted to take Ivermectin must present a doctor’s prescription before the pharmacy can compound and dispense the drug.
“The doctor and the pharmacist are responsible for the prescription and the drug dispensed,” FDA Director-General Eric Domingo told the Manila Bulletin in a message when asked about the legal implications of distributing Ivermectin.
Domingo added the FDA will also inspect compounding pharmacies to check and ensure their compliance with existing regulations.
While it is open to allowing the compounding of Ivermectin, the FDA and the Department of Health (DOH) have repeatedly cautioned the public against its use since it has not yet approved the drug for treating viral infections in humans.
The World Health Organization (WHO) also said that further studies and clinical trials are needed to prove Ivermectin’s effectiveness in treating or even preventing the coronavirus infection.
At present, Ivermectin is registered as an animal drug and only as a prescribed drug for humans in topical formulation, or ointment, to treat external parasites and skin conditions.
Herrera-Dy, however, likened the use of Ivermectin to the use of anti-inflammtory drug tociluzimab and anti-viral drug remdesivir for COVID-19 patients.
The FDA recommended the use of the two investigational drugs only for critical and severe coronavirus cases based on WHO Solidarity Trials.
“What makes Ivermectin different?” she asked, adding there are already “several foreign clinical trials” on its supposed potential in treating COVID-19.
Defensor also told the FDA: “If there are compounding labs then it’s best to monitor and regulate instead of killing supply which results to illegal production, smuggling and increase of prices.”
“Kung safe naman at baka makatulong eh bakit nila haharangin (If it is safe and could help, why will the FDA prevent it)?” he reiterated.