President Rodrigo Duterte has directed the Food and Drug Administration (FDA) to take the lead against the illegal trading or dispensing of ivermectin, an anti-parasitic drug for animals but believed to be effective against the coronavirus disease, Malacanang said.
The Palace said the President’s order was focused on ivermectin for veterinary use that has been repackaged to mislead the public, and advised the public to consult with doctors first before taking the drug.
“What is being ordered to stop is the sale/trade of ivermectin for veterinary use that has been repackaged as human-grade, including those that have not been determined by competent authorities as safe to be used in humans,” he said.
Presidential Spokesperson Harry Roque made this remark after Duterte directed the FDA to hold clinical trials for the use of the anti-parasitic drug to treat COVID-19 patients.
The President is closely monitoring the developments concerning the controversial drug ivermectin here and abroad, Roque said Wednesday.
Duterte’s order to the FDA overturned the previous stance of the Department of Science and Technology and the Department of Health that there was no need for a local ivermectin trial since over 40 global studies on the drug were being conducted.
Roque defended Duterte’s decision, saying the President wanted to find out if there was enough evidence to back the use of ivermectin to treat COVID-19.
“To ensure the safety and welfare of the public and at the same time avoid any unnecessary conflicts, the Food and Drug Administration has been directed to take the lead in determining the course of action against the illegal trading/dispensing of Ivermectin,” Roque said in a press statement.
Roque assured that efforts by the Philippine National Police to crack down on individuals engaged in the distribution of fake, unregistered, or unlicensed Ivermectin were being coordinated with the FDA.
“The Philippine National Police cannot arbitrarily determine on their own which drug/s should not be on the market. All operations to apprehend or seize goods must be done in coordination with the FDA,” he said.
Currently, there is a growing debate within the medical community whether ivermectin should be given to COVID-19 patients.
So far, the FDA has granted a compassionate special permit (CSP) for ivermectin use on COVID-19 patients to two hospitals amid pressure from some doctors and private groups advocating its use.
Prior to the grant of the CSP to the two hospitals, ivermectin products were used for certain animal species to treat internal and external parasites as well as prevention of heartworm disease in the country.
“The Palace further underscores what is being ordered to stop is the sale/trade of ivermectin for veterinary use that has been repackaged as human-grade, including those that have not been determined by competent authorities as safe to be used in humans,” Roque said.
Roque said Duterte continues to monitor developments concerning ivermectin, even directing the Presidential Management Staff to give him weekly updates on studies and FDA-related clearance on the drug.
Meanwhile, the spokesman urged the public to seek the advice of medical professionals before purchasing and taking ivermectin.
“We advise the public to seek the advice of medical practitioners before taking medicines and/or supplements,” he said.
The DOST earlier said local trials on ivermectin would give them a “reliable estimate” on the drug’s effect as an antiviral agent to “reduce virus shedding of mild and moderate patients.”
The World Health Organization, the United States FDA, the European Medicine Agency, and Ivermectin manufacturer, Merck, said there is a lack of data and evidence on its efficacy for COVID-19 prevention and treatment. With PNA