DOJ to study “sound legal basis” of FDA exemptions on use of ivermectin as COVID-19 treatment

The Department of Justice has yet to determine whether the exemptions set by the Food and Drug Administration (FDA) on the use of ivermectin as COVID-19 treatment has sound legal basis, following the plan of two congressmen to distribute the anti-parasitic drug.

“I wouldn’t really blame Representatives Defensor and Marcoleta if they will proceed (with the distribution) but as I said this is subject for a further determination if there is a legal basis for the exemption,” Justice Secretary Menardo Guevarra said in an ANC interview when asked if he will warn congressmen on their plan to distribute ivermectin.

On Tuesday, Representatives Rodante Marcoleta and Mike Defensor announced that they will distribute the anti-parasitic drug ivermectin as a possible treatment against COVID-19 beginning Thursday, April 29, in Quezon City, despite not being doctors.

Guevarra explained that the FDA Law punishes and prohibits importation, sale, distribution, and administration of unregistered drugs or vaccines.

“In the case of ivermectin, it is not registered particularly as drug for COVID-19 and going by the FDA law, on its face it would appear that the distribution of ivermectin as possible treatment for COVID-19 violates the FDA law,” Guevarra said.

However, he noted that FDA Director General Eric Domingo has stated two exemptions on the use of the said drugs to humans.

These exemptions are the issuance of compassionate special permit and if the said drug was prescribed by a doctor and was compounded by a duly licensed pharmacist.

“If Representatives Defensor and Marcoleta’s act of distributing ivermectin will fall into this two situations, it would appear that they can put this up as a defense in case a complaint is filed against them,” he said.

“But personally, whether the two cited by FDA director general has sound legal basis, that is something for further study. I’m not too sure on the soundness of the legal basis for the exemptions,” he added.

Guevarra further said that the legal consequences of the distribution will be seen “at the future time.”

Currently, the FDA has granted five hospitals with compassionate permit for use of ivermectin against COVID-19.

The FDA previously explained that this permit is not a marketing authorization, meaning ivermectin could not be sold commercially yet.

A CSP is also not an FDA endorsement of a drug’s quality and efficacy.

Meanwhile, two companies have already applied for certificate of product registration (CPR) for ivermectin before the FDA.

The CPR will allow manufacturers to sell the drug commercially and is an FDA guarantee that the drug is safe and effective.

Earlier, the World Health Organization said ivermectin should not be used in patients with COVID-19 except in the context of a clinical trial, noting that the current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive.

Science and Technology Secretary Fortunato dela Peña has said the Philippines will conduct clinical trials to determine whether ivermectin could be used as possible treatment for patients diagnosed with COVID-19.—AOL, GMA News