Manila Bulletin
Philippines
DOH: FDA building case vs. unregistered Fabunan injection claiming to be COVID-19 cure
Philippines
DOH: FDA building case vs. unregistered Fabunan injection claiming to be COVID-19 cure
DOH: FDA building case vs. unregistered Fabunan injection claiming to be COVID-19 cure
Published May 24, 2020 12:00 am
By Analou De Vera
The Food and Drug Administration (FDA) is now conducting a case-build up against the Fabunan antiviral injection that claims to be a cure for coronavirus disease (COVID-19), the Department of Health (DOH) said on Sunday (May 24).
Health Undersecretary Dr. Maria Rosario Vergeire said the Fabunan antiviral injection is not registered with the FDA.
Health Assistant Secretary Maria Rosario Vergeire (PNA / FILE PHOTO / MANILA BULLETIN)
"They still have not applied for CPR (certificate of product registration). They were already issued a cease-and-desist order by FDA. Case build up is being done already," Vergeire told reporters in a Viber message.
"The FDA has jurisdiction when it comes to the unregistered drug/vaccine, and PRC (Professional Regulation Commission) for the practice of medicine," she added.
Vergeire made the statement after reports circulated on social media that a community in Zambales received shots of the antiviral injection.
Last April, Vergeire said those who use the unregistered product will also be held liable.
In a separate statement, Vergeire said the DOH is “open to endorse treatments that have gone through rigorous studies.”
“We encourage local scientists who may have developed to apply with the FDA. We do this for the protection of the public, as many unregistered products have proliferated globally which might hurt people and even cause death,” Vergeire said.
“The DOH will continue to update our people of any scientifically proven developments in our fight against COVID-19,” she added.
Avigan
Meanwhile, Vergeire said they are still preparing for the conduct of clinical trials for the Japanese anti-flu drug Avigan despite doubts about its efficacy in treating the disease, as reported in the Japan Times.
“It is important for the Philippines to participate and contribute to the knowledge base for this investigational drug,” Vergeire said.
“We acknowledge the lack of evidence so far, but emphasize that these trials are still ongoing.”
Recently, the Health official said the DOH is currently coordinating with Japan for the delivery of Avigan, adding that three medical facilities in the country have been tapped to conduct the clinical trials.
Health Assistant Secretary Maria Rosario Vergeire (PNA / FILE PHOTO / MANILA BULLETIN)
"They still have not applied for CPR (certificate of product registration). They were already issued a cease-and-desist order by FDA. Case build up is being done already," Vergeire told reporters in a Viber message.
"The FDA has jurisdiction when it comes to the unregistered drug/vaccine, and PRC (Professional Regulation Commission) for the practice of medicine," she added.
Vergeire made the statement after reports circulated on social media that a community in Zambales received shots of the antiviral injection.
Last April, Vergeire said those who use the unregistered product will also be held liable.
In a separate statement, Vergeire said the DOH is “open to endorse treatments that have gone through rigorous studies.”
“We encourage local scientists who may have developed to apply with the FDA. We do this for the protection of the public, as many unregistered products have proliferated globally which might hurt people and even cause death,” Vergeire said.
“The DOH will continue to update our people of any scientifically proven developments in our fight against COVID-19,” she added.
Avigan
Meanwhile, Vergeire said they are still preparing for the conduct of clinical trials for the Japanese anti-flu drug Avigan despite doubts about its efficacy in treating the disease, as reported in the Japan Times.
“It is important for the Philippines to participate and contribute to the knowledge base for this investigational drug,” Vergeire said.
“We acknowledge the lack of evidence so far, but emphasize that these trials are still ongoing.”
Recently, the Health official said the DOH is currently coordinating with Japan for the delivery of Avigan, adding that three medical facilities in the country have been tapped to conduct the clinical trials.