MANILA, Philippines — Food and Drug Administration (FDA) Director-General Eric Domingo on Friday confirmed that his agency had issued a certificate of product registration (CPR) to Lloyd Laboratories for the manufacture and sale of ivermectin, thus paving the way for its legal human consumption.
In a text message, Domingo said the CPR, which Lloyd Laboratories applied for, was on the use of “locally manufactured ivermectin as an antinematode drug.” Nematode is a type of parasitic worm.
“[This] was granted after they submitted data to support [the] quality and stability of the product,” Domingo said.
He clarified that the CPR was not for use in treating or preventing COVID-19, adding that the purpose of the drug is still antiparasitic.
But the CPR granted to Lloyd Laboratories means anyone with a valid prescription for it can now purchase the drug.
Sought for comment, epidemiologist Tony Dans of the Health Professionals Alliance Against COVID-19 said, “It’s up to the people who to believe. I’m hoping 41 societies will make a difference.”
Associate groups of the alliance earlier warned against the use of ivermectin.
Dr. Tony Leachon, a health reform advocate, said the CPR was proof the FDA was “at its weakest.”
In a text message, the former government adviser warned: “The believers of ivermectin will surely use this for off-label indication—for COVID. A CPR allows the manufacturer to import the materials for the country. This makes the problem worse because the off-label indication will be abused.”
“Off-label” refers to the use of an approved medicine outside of its approved indication.
According to the United States’ FDA, “off-label” can mean a drug is used for a disease or medical condition it is not approved to treat.
“Our regulatory agencies like the FDA and even the DOH (Department of Health) should stand firm,” Leachon said. “It’s unfortunate that this would happen at a time when we should be focused on COVID pandemic response.”
Anakalusugan Rep. Michael Defensor called the FDA’s decision a “great victory for the advocates of ivermectin.”
“I congratulate the doctors who stood their ground knowing that ivermectin will save our people, especially the poorest of the poor. I hope the medical associations will retract their statements against our ivermectin doctors and we all work together in fighting COVID-19. Off-label prescription is the right of every doctor and patients fighting for their lives,” he said.