Ivermectin distribution, promotion against FDA law – DOH

The Department of Health on Wednesday warned those who are distributing and promoting unregistered drugs such as ivermectin are violating Republic Act 9711 or the Food and Drug Administration Law.

“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.

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

 Vergeire added that people who are not healthcare professionals could not just distribute 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.

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

Ivermectin distribution, promotion against FDA law – DOH

The DOH official said those promoting and distributing ivermectin are likewise violating the FDA Law.

“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.

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Meanwhile, Anakalusugan party-list Representative Mike Defensor insisted that there is nothing illegal with him wanting to distribute anti-parasitic drug ivermectin as a treatment for COVID-19 patients in Quezon City.

Defensor told Dobol B TV on Tuesday that the drug is coming from legal compounding laboratories. He noted that a physician’s prescription is still required to use this alleged COVID-19 drug.

“Ang  (Department of Health) at FDA (Food and Drug Administration), sinasabi nila wala pang clinical trials, tama po ‘yun pero sinasabi din nila oh puwede na kayong mag-prescribe. Ang ginagawa ko po ay sa regulasyon ng batas, after FDA law at kung ano ‘yung ginagawang alituntuntin ng FDA,” Defensor said.