MANILA, Philippines – The Food and Drug Administration (FDA) has issued cease and desist order against the Fabunan antiviral drug, developed by Filipino doctor and claimed as cure for the deadly coronavirus disease 2019 (COVID-19).
"They still have not applied for certificate of product registration or CPR. They were already issued a cease and desist order by FDA, case buildup is being done already," Department of Health (DOH) Undersecretary Maria Rosario Vergeire told reporters on Sunday.
Vergeire added the Health department is now studying the cases related to the Fabunan drug.
"We are studying the case already. FDA has jurisdiction when it comes to the unregistered drug or vaccine, and PRC (Professional Regulation Commission) for the practice of medicine," she said.
While the world is still in a race to come up effective vaccine against COVID-19, the Palace instructed FDA to study the effectiveness of the Fabunan antiviral injection.
A video about the drug is circulating on social media, claiming that Fabunan is a patented antiviral drug against dengue and that it is an “approved” drug and has been “proven to be used to treat COVID-19”.
Ruben Fabunan, a physician now based in the US, developed the anti-viral drug together with three brothers, who are all doctors. They have a family clinic in San Marcelino, Zambales where the injection is available for their walk-in patients.
FDA on April 8 warned the public on drugs and vaccines with unproven claims for COVID-19 treatment, citing the Fabunan drugs.
"Manufacturers and vendors of unlicensed products such as PRODEX B and the Fabunan Antiviral Injections have been informed regarding the process and requirements to register their products with the FDA Center for Drug Regulation and Research (CDRR).
No applications for product registration have been filed to date. Until such products are proven safe and effective for use in the treatment of COVID-19 they cannot be dispensed to the public nor can therapeutic claims be made," FDA said.
There are on-going clinical trials to investigate the safety and efficacy of new and existing drugs, such as anti-viral, anti-bacterial, and anti-malarial agents in the treatment of COVID-19 patients.
The World Health Organization (WHO) recently launched the Solidarity Trial, a large-scale clinical trial participated by many countries (including the Philippines), which aims to identify evidenced-based treatment regimen for COVID-19.
— The Summit Express
"They still have not applied for certificate of product registration or CPR. They were already issued a cease and desist order by FDA, case buildup is being done already," Department of Health (DOH) Undersecretary Maria Rosario Vergeire told reporters on Sunday.
 |
| The Food and Drug Administration (FDA) has issued cease and desist order against Fabunan antiviral drug, Undersecretary Maria Rosario Vergeire told reporters on Sunday, May 24. |
Vergeire added the Health department is now studying the cases related to the Fabunan drug.
"We are studying the case already. FDA has jurisdiction when it comes to the unregistered drug or vaccine, and PRC (Professional Regulation Commission) for the practice of medicine," she said.
While the world is still in a race to come up effective vaccine against COVID-19, the Palace instructed FDA to study the effectiveness of the Fabunan antiviral injection.
A video about the drug is circulating on social media, claiming that Fabunan is a patented antiviral drug against dengue and that it is an “approved” drug and has been “proven to be used to treat COVID-19”.
Ruben Fabunan, a physician now based in the US, developed the anti-viral drug together with three brothers, who are all doctors. They have a family clinic in San Marcelino, Zambales where the injection is available for their walk-in patients.
FDA on April 8 warned the public on drugs and vaccines with unproven claims for COVID-19 treatment, citing the Fabunan drugs.
"Manufacturers and vendors of unlicensed products such as PRODEX B and the Fabunan Antiviral Injections have been informed regarding the process and requirements to register their products with the FDA Center for Drug Regulation and Research (CDRR).
No applications for product registration have been filed to date. Until such products are proven safe and effective for use in the treatment of COVID-19 they cannot be dispensed to the public nor can therapeutic claims be made," FDA said.
There are on-going clinical trials to investigate the safety and efficacy of new and existing drugs, such as anti-viral, anti-bacterial, and anti-malarial agents in the treatment of COVID-19 patients.
The World Health Organization (WHO) recently launched the Solidarity Trial, a large-scale clinical trial participated by many countries (including the Philippines), which aims to identify evidenced-based treatment regimen for COVID-19.
— The Summit Express
