Lawmakers and doctors violated the law when they distributed and promoted the anti-parasitic drug Ivermectin to treat coronavirus patients without approval of Philippine regulators, the Department of Health (DoH) said Wednesday.
Health Undersecretary Maria Rosario Vergeire noted that unregistered drugs are prohibited for distribution in the Philippines as stated under the Food and Drug Administration Act (FDA) of 2009 or Republic Act (RA) 9711.
“The law specifically stated that unregistered drugs should not be given to our countrymen,” Vergeire said in a news conference.
Under RA 9711, the “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded” is prohibited.
Those who will violate the law may face imprisonment ranging from one year but not more than 10 years or a fine ranging from P50,000 to 5 million.
The DoH’s latest warning came amid reports that a number of doctors and lawmakers distributed free Ivermectin products to treat Covid-19 patients even without the FDA’s green light for its use.
A day earlier, FDA Director-General Eric Domingo said the use of human-grade Ivermectin drug is “legal” if prescribed by a physician and compounded by a licensed pharmacy.
President Rodrigo Duterte, however, has instructed the FDA to evaluate the effectiveness of Covid-19 medications applying for permits in the country, particularly human-grade Ivermectin, Senator Christopher Lawrence ‘Bong’ Go said.
Go stated that the Chief Executive has asked FDA to thoroughly assess and validate claims on the drugs emphasizing that it should be in accordance with existing laws and regulations to ensure its safety and efficacy.
He said the President is open to approving any medication if it can help in easing the country’s pandemic situation but its safety should be verified first.
“He (Duterte) directed FDA Director-General Eric Domingo to study and ensure the safety of Ivermectin to humans. Let us just wait for the results. Rest assured we are always following it up with him,” the senator said in a statement.
Go, chair of the Senate Committee on Health and Demography, has backed calls earlier urging health agencies to facilitate scientific research and consult with medical experts to determine the possible uses, side effects, and risks of Ivermectin as a potential treatment for coronavirus.
Ivermectin is yet approved by the FDA for human use and its permit is limited to treating parasitic ailments of animals at present. Ivermectin products commercially available in the country for human use are in the form of a topical cream for skin application.
Medical experts here and abroad have also warned against the use of Ivermectin, noting the lack of reliable data demonstrating its benefits.
They have also expressed concern over the drug’s risks and potential side effects such as hypotension or low blood pressure, allergic reactions, seizures, coma, and even death.
Anakalusugan Partylist Rep. Mike Defensor previously offered to distribute free “human-grade” Ivermectin to senior citizens and other people with ailments in Quezon City. He insisted that did not violate the law.
In a television interview, Defensor said he has coordinated with a compounding laboratory to make the drug.
He also said in separate media interviews that some congressmen have been using Ivermectin, but he did not name them.
Dr. Allan Landrito, the most vocal proponent of Ivermectin for Covid-19 treatment, said in a House health panel hearing last month that he had made Ivermectin pills on his own and sold it to around 8,000 patients across the country.
While the DoH said that it had received the application for registration of Ivermectin, it maintained its position that it “does not recommend the use” of the anti-parasitic drug to treat Covid-19 pending reliable data proving that the drug’s benefits outweigh its risks.
FDA’s Domingo said there is “not a lot of room” for pressure in evaluating whether the anti-parasitic drug is appropriate for human use.
“The pressure is always there, but the good thing about FDA is that the requirements are clear-cut when you want to register a drug for safety and efficacy,” he said in an interview with CNN Philippines. (With Sundy Locus)