FDA: Off-label use of Ivermectin is not illegal 

Published April 20, 2021, 12:27 AM

by Former Senator Atty. Joey D. Lina

FINDING ANSWERS

Former Senator
Atty. Joey Lina

With the surge in COVID-19 cases overwhelming the healthcare system and filling hospitals to maximum capacity, many are fearful for their families, especially those with high-risk members who can be infected and can quickly deteriorate or even die within days.

The impact of the raging pandemic has certainly gotten closer to home. Almost twice or thrice a week, for the past several weeks, I’ve gotten shocking news about deaths or sickness of friends, relatives, associates, and acquaintances.

With the current shortage of supply of vaccines in the country, people are desperate for solutions and other alternatives to ward off the perennial threat of getting infected, or at least getting a fighting chance to survive when severely hit by the coronavirus. And many attest that one of the alternatives is the human-grade Ivermectin drug.

Indeed, many believe that Ivermectin, repurposed as a human-grade drug to prevent and treat COVID-19 cases, will do much good based on widespread testimonials and studies made on it.

But Ivermectin continues to encounter rough sailing and many are not happy about the situation. As noted sociologist Randy David said, “it is not easy to explain why so-called ‘emergency use authorization’ is granted to vaccines for use in mass vaccination programs on a global scale, based only on interim findings concerning their efficacy and safety. Yet not even a small measure of this guarded optimism is accorded to possible cures like Ivermectin.”

The recent call by leaders of various professional organizations and top business and industry groups to consider Ivermectin expressed extreme urgency: “We are in a severe public health emergency. Our people are dying in big numbers on a daily basis and our hospitals can no longer accommodate those who are getting sick of the virus. The number of cases is growing bigger and bigger. Our people are desperate for a preventive and curative drug against COVID-19.”

Their call “to give serious, urgent and immediate attention to Ivermectin as an inexpensive drug to prevent and treat COVID-19 during this public health crisis” prompted me to do my utmost to be of help.

Thus, last April 12, I sought the intercession of Senator Bong Go to get in touch with pertinent authorities and try to make things happen. In his Facebook post, Sen. Go narrated what transpired and he also shared his insights on the need to look into Ivermectin. Here’s what he posted:

“Former Senator Joey Lina reached out to me regarding his concerns on Ivermectin. We immediately clarified matters with Health Secretary Francisco Duque and Food and Drug Administration (FDA) Director General Eric Domingo through a conference call this morning.

“Based on our conversation, DOH and FDA reiterated that the use of Ivermectin that is registered as ‘human-grade’ is not illegal, provided that the regulatory processes to ensure its safety and efficacy are followed in accordance with our existing laws and procedures.

“I continue to urge our health officials to facilitate a thorough scientific study and consult local and international medical experts on the possible uses, side effects and risks of Ivermectin as a potential medication for treating COVID-19.

“Let me clarify that I am not advocating the use of any specific drug, but I am simply urging the government to have an open dialogue with proponents and facilitate a thorough scientific study of these proposals.

“Ang importante dito ay maging mas proactive tayo. Huwag natin pahirapan yung mga nais tumulong. At klaruhin natin ang ating mga patakaran para masigurong ligtas at epektibo ang mga gamot na pwedeng gamitin ng mga tao. (It is important to be proactive. Let us not give a hard time to those who want to help. And let us be clear on regulations to ensure the safety and effectiveness of drugs that could be used by people.”

That conference call organized by Sen. Go with top officials of the Department of Health and the (FDA) led to a clear statement issued by the FDA  declaring that the off-label use of Ivermectin is not illegal.

“Off-label use of Ivermectin means that there are some physicians that prescribe it in a way to treat patients which are not within the FDA-approved indications for use or dosage regimen as written in the product label or product insert. Off-label use by physician is not illegal but it is not encouraged by DOH, FDA especially without the consent of the patient,” the FDA said.

It must be stressed that FDA is the specific designated government agency under RA 9711 and approves and authorizes, among others, the manufacture, importation, distribution and sale of drugs in the country. 

But contrary to the FDA’s declaration, DOH undersecretary and spokesperson Maria Rosario Vergeire, asserted, when she was  an online guest in my TeleRadyo program Sagot Ko ‘Yan last Sunday, that using Ivermectin “can be considered illegal.”

“Based on RA 9711, because we still do not have any registered Ivermectin in the country, kapag gumamit ka (if you use) outside of the compassionate special permit that was given by FDA, that can be considered illegal,” she insisted.

Her statement is causing confusion among doctors because the FDA statement is clear and unequivocal, and not subject to any interpretation. “Off label use by physician is not illegal”, as long as consent is given by a patient  to the doctor prescribing it.  Another online guest in my TeleRadyo progam, Dr. Oscar Tinio, spokesperson of the Philippine Medical Association, lamented that what the DOH spokesperson uttered is very confusing to doctors.

Such conflicting positions between the FDA and the DOH ought to be promptly clarified, lest the ensuing confusion could be costly in terms of human lives that could be saved from the onslaught of COVID-19.

Email: [email protected]

 

 
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