Guevarra on ivermectin: Defensor should know what’s allowed, prohibited under FDA law

Mike Navallo, ABS-CBN News

Posted at Apr 06 2021 08:08 PM | Updated as of Apr 07 2021 04:16 AM

MANILA — Is Anakalusugan party-list Rep. Mike Defensor violating the law by offering free access to an unregistered drug, which some groups are touting as a possible cure to COVID-19?

Justice Secretary Menardo Guevarra did not directly answer the question Tuesday, saying it is not a specific case before his office but he gave a generic answer:

“Generally speaking, it is prohibited, under the FDA law, to manufacture, import, export, sell, offer to sell, distribute, transfer, promote, advertise, etc… health products that are unregistered with the FDA,” he said in a text message to reporters.

“I am sure that as a lawmaker, Rep. Mike Defensor knows the FDA law very well and that he is very much aware of what acts are allowed and what acts are prohibited under the said law,” he said in another message.

Republic Act 3720, as amended by RA 9711 or the FDA Act of 2009, prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded.

It also prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any health product which, although requiring registration, is not registered with the FDA.

The law imposes jailtime on violators of between 1 year to 10 years and fines ranging from P50,000 to P5 million, depending on the level of involvement.

In a Facebook post, Defensor offered Quezon City residents access to Ivermectin, registered in the Philippines as an anti-parasitic drug for animals, which some have claimed can cure or prevent COVID-19, despite warnings from the Food and Drug Administration, the World Health Organization and its manufacturer, Merck, against its use for COVID-19 treatment.

“Ito po ay libre naming pamimigay sa higit na nangangailangan at magkakaroon ng prioritisasyon sa pamamahagi nito sa ating mga kababayan sa lungsod. Ang mga may sakit lalo’t higit ang ating mga senior citizens ang ating uunahin,” Defensor said, encouraging those interested to send a private message.

(We’ll be giving this free of charge to those who most need it and there will be priorities in the distribution to our citizens in the city. Those with ailments, most especially senior citizens will be prioritized.)

Defensor however did not explain why he is offering the drug to Quezon City residents only when his party-list has a nationwide mandate, except to say that there’s a limited supply.

Prior to Defensor’s offer of Ivermectin, posters of him and Vincent “Bingbong” Crisologo, a former candidate for Quezon City mayor, appeared on social media, with both of them in front of the Quezon Memorial Shrine, leading to speculations both are running for government posts in the city in the May 2022 polls.

WARNINGS AGAINST IVERMECTIN AS COVID-19 CURE

The Philippine Food and Drug Administration, in an advisory on March 15, advised the public against the purchase and use of Ivermectin for COVID-19, saying it is not approved by FDA for treatment of any viral infection.

Instead, what is registered with FDA for human form are topical formulations of the drug for treatment of external parasites such as head lice and skin conditions while those for animals come in oral and intravenous forms.

“The public is warned against taking animal drugs, as the FDA has only evaluated their safety and efficacy in the particular species for which they are labeled. Using these products in humans can cause serious harm. Animal drugs are often highly concentrated and can be highly toxic to humans,” it said.

“Any use of Ivermectin veterinary products for the prevention or treatment of COVID-19 should be avoided as the benefits and safety for this purpose has not been established. Data from clinical trials are necessary to determine whether Ivermectin is safe and effective in treating or preventing COVID-19,” it added.

The United States FDA has also issued a warning, saying taking large doses of the drug is “dangerous and can cause serious harm.”

It did however acknowledge situations where prescription for use of Ivermectin may be obtained.

The World Health Organization meanwhile said the current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive. Until more data is available, WHO recommends that the drug only be used within clinical trials.

Ivermectin’s manufacturer, US-based Merck, issued a statement in February this year clarifying there is “no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies” and “no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease.”

LOBBYING FOR IVERMECTIN

Despite this, some doctors from around the world, including a Filipino doctor, and some politicians in the Philippines have lobbied for the use of Ivermectin, citing anecdotal evidence from persons who allegedly got cured from COVID-19 by taking it.

The main proponent for the use of Ivermectin globally is a group of doctors called the Front Line COVID-19 Critical Care Alliance (FLCCC) which cited studies in different countries supposedly showing reduced deaths by 75% in 2 medical centers in the United States.

But other science experts have questioned the lack of a randomized controlled trial in the studies the proponents cited, saying the pandemic should not be used as an excuse to lower the standards for scientific evidence.

Merck, the manufacturer, has expressed concern over the “lack of safety data in the majority of studies.”

In the Philippines, Dr. Allan Landrito told a House panel on March 30 that he bought pure Ivermectin from an importer and compounded it himself, selling more than 25,000 bottles to around 8,000 patients before he stopped.

Landrito claimed he sold the drug without waiting for an FDA permit out of urgency and the pleas of his patients begging him to treat them. 

ILLEGAL TO DISTRIBUTE UNREGISTERED DRUGS BUT…

On Tuesday, FDA director general Usec. Eric Domingo explained it is illegal in the Philippines to distribute unauthorized medicines but he acknowledge there might be an exception to the rule.

“Kung unregistered po kasi bawal po talaga iyon o unauthorized. Hindi ko po alam baka meron silang compounding pharmacy na kausap na magrereseta at gagawin. Hintayin po natin ang detalye,” he said on TeleRadyo.

(If it’s unregistered, it’s not allowed or unauthorized. I just don’t know if they have a compounding pharmacy who can issue a prescription. We need to wait for details.)

“Siguro alam naman po nila ano ang batas at kung ano ang paraan ng pagkonsulta, pagcheck-up ng doktor, pagreseta, pagdispense ng gamot ng pharmacists…Hindi naman natin kung ano ang mekanismo, kung magiging clinic ba ito, may doctor ba at may pharmacist, but we hope na naiintindihan po natin lahat kung ano po yung tamang paraan na tama po sa pagbigay ng gamot sa pasyente,” he added, referring to Defensor’s plan.

(I believe they know the law and the process for consultation, check-up, prescription and dispensing of drugs by pharmacists…We don’t know what’s the mechanism, if it’s going to be a clinic, if there’s a doctor and pharmacist, but we hope that we all understand the proper process for dispensing medicines to patients.)

Domingo said an application for certificate of product registration of Ivermectin has been filed on Monday.

Defensor, who earlier tested positive for COVID-19, admitted taking Ivermectin and claims it is “one of the safest drugs in the world.”

He said he is "not doing anything outside of the law" and is coordinating with a compounding laboratory and that he would give away Ivermectin for free for those with prescription.

Meanwhile, Defensor's colleague, Quezon 4th District Rep. Angeline "Helen" Tan, has urged fellow-lawmakers not to encourage the use of Ivermectin against COVID-19 due to lack of evidence. 

"Medicine is evidence-based. It's not based on testimony or opinion,” she said.

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