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FDA to talk with maker how to hasten Ivermectin registration as COVID-19 drug

The Food and Drug Administration (FDA) will discuss with the manufacturer how it could hasten the use of Ivermectin as treatment for COVID-19, FDA director general  Eric Domingo told a House inquiry on Tuesday.

"Basta pag kumpleto po yung requirements at sinubmit lahat ng requirements, kaya po yan within 4 to 6 weeks ang certificate of product registration. Ang CSP ay 24 to 48 hours," Domingo said during a House hearing on Ivermectin as an anti-COVID-19 drug.

"So ang usapan namin, we will talk with manufacturers next week to see kung ano mas mabilis na way na makapag-rehistro ang produkto," the FDA chief added.

Domingo was replying to House Deputy Speaker Kristine Meehan's question on whether the drug will be approved for human use after two months.

"We are thinking of CPR (certificate of product registration) talaga kaya lang maraming requirement ang CPR so I think if the Ivermectin is included in the treatment guidelines of DOH for covid-19 then mas madali na kasi pwede siyang emergency drug use then mas konti requirements, mas mabilis ang processing noon," he explained.

Under FDA guidelines, Domingo said the approval for CPR will take four to six weeks while approval for compassionate special permit takes about two weeks.

Domingo said they would review applications of products "objectively," adding that they are only doing their jobs as authorized by the FDA.

Health Secretary Francisco Duque III, for his part, vowed that they will look into using Ivermectin for COVID-19 medicine but noted that it should be backed by research and the law.

"Ako ay sumusuporta sa posisyon ng ating mambabatas pero gawin natin sa tamang paraan kundi sundin ang batas. Ito ay dumaan sa mga hearings, ilang beses po yan yung RA 7911,... tayo po as implementers and executives of government e talagang we have to do thinkful implementation of law that went through very broad study of provisions of the law," Duque said during the House inquiry.

"Let me just assure the congressman, we will look into this right away and we will see the use this preparation of Ivermectin but at the same time ensuring that there is enough safety data as they claim, yun ang ginagawa ng nagpakadalubhasa ang technological experts... Let me just  reassure you that we will look into this immediately," he added.

Anakalusugan Rep. Mike Defensor, who said he received Ivermectin while he was infected with the virus, lamented the slow process of approving Ivermectin to be used as COVID-19 medicine. He is also pushing for the immediate use of Ivermectin for COVID-19 treatment, citing casualties of the severe viral ailment.

"Mali ho ito mali ang ginagawa ninyo na pinapahirapan ninyo ang taong nagpoproduce nito na kunyari pinapayagan ninyo yung compassionate permit na gusto ninyo ganyan po katagal yan," a furious Defensor said.

"Huwag niyong sabihin na magregister, Sec. Domingo, Sec. Duque you have to be proactive... you have to do something. Maraming namamatay," he added.

FDA previously said the Ivermectin veterinary products are only approved for use in the prevention of heartworm disease and treatment of internal and external parasites in certain animal species. It discouraged the public from using it for COVID-19 treatment.

Questions on safety

Earlier, a doctor said there is no solid proof yet that using Ivermectin as treatment against COVID-19 is safe.

Interviewed on Dobol B TV, Dr. Edsel Salvana, a molecular biologist and Department of Health (DOH) advisor, said health experts are not totally against the use of Ivermectin. However, he said further studies should be done to ensure it is safe for patients.

"'Yung safety niyan may question mark pero of course, side effect versus benefit, kung mayroon naman tayong nakitang benefit bakit hindi? Kailangan nating ibalanse," Salvana said.

"Wala na tayong Ivermectin na registered ngayon for people sa FDA. Nag-lapse na siya since 2018. Walang FDA-registered na properly na-assess na human formulation," he added.

Dr. Allan Landrito, an integrative medical doctor, earlier said Ivermectin has been useful in combating other viral diseases aside from being an anti-parasitic drug.

He said it has also been used as an anti-cancer and immunomodulatory drug.

"'Yun ang akala ng marami, anti-parasitic siya pero 'di naglaon, natagpuan na anti-viral siya noong 2012. Nakita mahusay siya sa viruses, kagaya ng dengue, lahat ng strains. Maging sa influenza, HIV, Zika, Chikungunya at iba pa," Landrito told Dobol B TV.

Citing the World Health Organization, Landrito further stressed that Ivermectin reduces COVID-19 mortality rate by 83%.

During the hearing, Landrito said he has filed for a license to operate with the FDA, but it has yet to be acted upon by the agency.

"Certainly, I have not applied for CPR because a pre-requisite for applying for that is license to operate. I have filed my license to operate.. but they ae delaying and delaying," he said, adding that he submitted his application on February 11 this year.—LDF, GMA News