THE Food and Drugs Administration has granted a third hospital compassionate special permit (CSP) for the use of the controversial drug ivermectin on COVID-19 patients, Director General Eric Domingo told the House committee on good government and public accountability yesterday.
Ivermectin is a drug used for parasite infestations in humans and animals.
The special permit allows limited use of investigational drugs or unregistered drugs.
Domingo did not name the third hospital. The first two remain unidentified.
Domingo said another hospital is seeking a CSP but the application remains pending because of lack of some documents.
The World Health Organization last month recommended against using ivermectin in patients with COVID-19 except for clinical trials, because of a lack of data demonstrating its benefits. The recommendation followed a warning of the European Medicines Agency against the drug. The US Food and Drug Administration (FDA) has also recommended it not be used for COVID-19.
Several groups have been asking government to allow the use of the drug, including AnaKalusugan party-list Rep. Mike Defensor who earlier this month said he would give away ivermectin to Quezon City residents.
Iloilo Rep. Janette Garin, a former health secretary, earlier said the FDA could be held liable for granting “compassionate use” of the anti-parasitic drug, saying it goes beyond the guidelines provided for under Administrative Order No. 4 which was issued by the late former health secretary and senator Juan Flavier in the early 1990s.
The AO, which was amended last year, contains guidelines on issuing CSPs for restricted use of unregistered drug and device product or preparation.
Garin has said the FDA cannot engage in politics, saying its move to grant CSPs seems to be “based on the push of many politicians and many powerful people in enticing to take ivermectin.”
The FDA has said any use of Ivermectin veterinary products for the prevention or treatment of COVID-19 “should be avoided as the benefits and safety for this purpose has not been established.”
In an advisory last month that, the FDA said the registered ivermectin products in the country for human use are only in topical formulations under prescription use only for the treatment of external parasites such as head lice and skin conditions. It said the registered oral and intravenous preparations of ivermectin are veterinary products which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species.
The FDA, however, has also said those who want to use Ivermectin for the treatment of COVID-19 patients may apply for a CSP which is neither a registration of nor a permit to market a drug.
Domingo told the hearing that a certificate of product registration (CPR) could come sooner for ivermectin than emergency use authorization (EUA) because a request was filed last week.
“Actually, that (CPR) will be easier kasi kapag CPR puwede talaga siyang ibenta, i-market commercially (Actually, that will be easier because a CPR would allow them to sell and market it commercially),” he said.
The Department of Science and Technology, on President Duterte’s order, will begin clinical trials of ivermectin in patients with COVID-19 to determine their efficacy in combating the
coronavirus, according to Science Secretary Fortunato dela Peña.
The clinical trial could last for six months, he said.
The House panel conducted the inquiry into alleged questionable guidelines and policies of the Department of Health and the FDA in approving EUAs for COVID-19 drugs, saying it “hampers public health service delivery to the Filipino people.”
