Distribution, promotion of ivermectin violate FDA Law —DOH

Persons who are distributing and promoting unregistered drugs such as ivermectin are violating Republic Act 9711 or the Food and Drug Administration Law, the Department of Health (DOH) warned on Wednesday.

“The most important law that is being violated for this supposed dispensing of ivermectin is RA 9711. Ito ‘yung FDA Act of 2009 and specific to that law sinabi mismo na yung mga hindi rehistradong gamot ay hindi natin pwedeng ipagamit sa ating mga kababayan,” Health Undersecretary Maria Rosario Vergeire said in a media briefing.

(This is the FDA Act of 2009 and the law specifically states that we cannot let the public use unregistered drugs.)

She added that people who are not healthcare professionals cannot just dispense any medicines for patients’ use.

“Pangalawa, ang mga pag-dispense ng gamot ay dapat mga doktor at mga healthcare professionals ang gumagawa, hindi puwedeng mga ordinaryong tao ang nagdi-dispense ng mga gamot na ito,” she said.

(Secondly, doctors and healthcare professionals are the only ones who are allowed to dispense medicines. Ordinary people cannot just dispense these drugs.)

Vergeire said that promoters of ivermectin are likewise violating the FDA Law.

This was her response when asked on the possible liabilities of some lawmakers who are advocating for ivermectin.

“Ang nakalagay sa batas natin sa RA 9711 is manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, or advertising or sponsorship of health protocols without proper authorization of FDA is prohibited. I think that is self-explanatory,” she said.

On Monday, Anakalusugan party-list Representative Mike Defensor announced that he would distribute ivermectin to treat patients infected with COVID-19 in Quezon City even if the medicine is still unregistered for human use.

The FDA earlier warned that the ivermectin grade that is approved in the Philippines is the one used for animals.

Despite the warning from FDA and the DOH, Defensor insisted on Tuesday that there is nothing illegal in pushing for the use of ivermectin to treat COVID-19 patients.

Currently, an application for Certificate of Product Registration for ivermectin is pending before the FDA.

Presidential spokesperson Harry Roque also disclosed that a compassionate special permit was filed before the drug regulatory agency. —KBK, GMA News