Dispensing ivermectin for COVID-19 patients violates FDA law, says DOH

Kristine Sabillo, ABS-CBN News

Posted at Apr 07 2021 04:31 PM | Updated as of Apr 07 2021 08:53 PM

Video courtesy of Department of Health

MANILA (UPDATED) — People dispensing anti-parasite drug ivermectin to treat COVID-19 in the Philippines are violating the Food and Drug Administration Act of 2009, the Department of Health (DOH) said Wednesday.

“The most important law that is being violated for this supposed dispensing of ivermectin is RA (Republic Act) 9711. Ito yung (This is the) FDA Act of 2009," Health Undersecretary Maria Rosario Vergeire said during a virtual briefing.

"Specific to that law, sinabi mismo (na) yung mga hindi rehistradong gamot, hindi pwedeng ipagamit sa ating mga kababayan,” she added.

(Specific to that law, it states that unregistered drugs cannot be given to the public.)

Vergeire said the law also requires that prescription of medicines must only come from doctors and other health professionals.

“Hindi pwedeng ordinaryong tao ang nagdi-dispense,” she said.

(Ordinary people cannot dispense drugs.)

Vergeire issued the statement in response to reports that lawmakers are promoting the use of ivermectin for COVID-19 patients even though the drug is not approved for such use.
 

The World Health Organization (WHO) has recommended against using the drug in patients with COVID-19 except for clinical trials, because of a lack of data demonstrating its benefits.

The recommendation follows the European Medicines Agency's warning against the drug. The US Food and Drug Administration (FDA) has also recommended it not be used for COVID-19.

Merck, an ivermectin manufacturer, has also said its analysis did not support the drug's safety and efficacy for COVID-19.

According to the DOH, ivermectin products registered in the country are for veterinary use, and are only allowed for the treatment of internal and external parasites as well as prevention of heartworm disease.

Vergeire warned that taking unregistered drugs is risky because there is no assurance that they are safe for people.

Lawmaker Mike Defensor has offered to distribute the drug as COVID-19 treatment and denied he is violating any law. 

"There should be an accompanying prescription to it. How it should be taken and the amount based on weight. For those sick with COVID, there is also a protocol," Defensor said.

Asked if lawmakers will also be held liable for promoting ivermectin for COVID-19, Vergeire said, “Nakalagay sa batas natin sa RA 9711: manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion or advertising or sponsorship of health (products) without proper authorization of FDA if any is prohibited."

"I think that’s self-explanatory," she added.

In a social media post, Defensor claimed that he was not prescribing drugs. “I am only giving people access to ivermectin,” he said.

He also claimed that the cost of the drug has increased in the black market where there is also no assurance that the products being sold are authentic.

He also said that they will follow the law and the FDA guidelines.

The DOH said in a previous statement that a systematic review of 6 randomized controlled trials showed that ivermectin did not significantly reduce risk of mortality and duration of hospitalization among COVID-19 cases.

It is also “not associated with a definite benefit of other clinically important outcomes.”

Currently, ivermectin is undergoing evaluation for possible issuance of compassionate special permit with the FDA.

A compassionate special permit allows experimental or unregistered drugs for limited off-label use. Acquiring such a permit does not mean, however, that the drug is proven to be effective since that requires a clinical trial.

The interest in ivermectin increased as COVID-19 cases surge in Metro Manila and its nearby provinces. The country's cumulative total cases reached more than 800,000 this week.

- with a report from Reuters