Defensor insists his Ivermectin distribution is within FDA process, parameters

Rep. Mike Defensor of Anakalusugan Party-list. FILE PHOTO

MANILA, Philippines — Anakalusugan Rep. Mike Defensor insisted Tuesday his distribution of anti-parasitic drug Ivermectin to residents of Quezon City is “within the process and parameters” set by the Food and Drug Administration (FDA).

Defensor, a lawmaker, made the remark amid questions on his move to distribute compounded Ivermectin despite pronouncements from medical experts that there is not enough data supporting the drug’s effectiveness to fight off COVID-19.

“What I’m doing now is within the process and within the parameters na ginawa ng [put up by the] FDA at DOH [Department of Health],” Defensor told reporters.

According to Defensor, there is an urgency to address the coronavirus pandemic as the death toll continues to increase in the country.

“Bago magkaroon ng approval ng FDA, dapat may mag-register. Batay doon sa ating batas, it is within six months at karamihan nga more than six months para magkaroon ng trial para isang droga ay payagan ng ating FDA,” Defensor said.

(Before a drug gets the approval of FDA, it should register. Based on our laws, it takes six months or more for a drug to be approved by the FDA.)

“Seven months para matapos ito ay marami nang namamatay, marami nang nagkakasakit ất sa ating paniniwala, lalong higit yung namamatay, 13,000 na yung namamatay sa ating bansa. Kung ito ay papayagan sana nila, nalaman na natin ang tungkol dito sa Ivermectin, maaaring nasagip natin yung 10,000 dito sa ating namatay,” he claimed.

(It might take seven months for it to be over and many have died already, 13,000 have died already in the country. We believe many more would die.)

However, both the FDA and the DOH have repeatedly said that there is no registered Ivermectin drug in the country for human use.

While FDA Director General Eric Domingo said that licensed pharmacies can indeed compound Ivermectin for human use as long as a patient has a prescription from a doctor, he also stressed that there is not enough data to say that the drug is effective to treat COVID-19.

Even the World Health Organization (WHO) has said it does not back the use of Ivermectin for the prevention or treatment of COVID-19, saying it does not have statistically significant evidence of efficacy against the new coronavirus disease.

JPV