The FDA debunked the claim. Its chief also said the drug has no application for registration yet.
YouTube videos promoting the supposed approval of a Filipino-made antiviral concoction against the novel coronavirus continue to be shared on Facebook (FB), two months after they were first uploaded. They are incorrect.
The Fabunan Antiviral Injection (FAI), a patented antiviral drug against dengue was developed by US-based Filipino doctor Ruben Fabunan. It has been in the news since March after unvalidated claims that it is effective in treating patients with COVID-19 spread on social media.
FAI has not been approved by the Food and Drug Administration (FDA) for use in the Philippines. And according to a VERA Files Fact Check interview with the Embassy of the Republic of Indonesia, “there hasn’t been anything granted” to FAI in the Southeast Asian country.
In early June, at least two videos made spurious claims about the drug’s approval.
Youtube channel Hot in Hoops on June 6 uploaded a video headlined GOOD NEWS!!! FABUNAN ANTI-VIRUS INJECTION HAS NOW (sic) APPROVED IN INDONESIA AND PHILIPPINES #FABUNAN.
It spliced two unrelated videos -- one of Health Undersecretary Rosario Vergerie speaking about the monetary benefits of families of healthcare workers who died of COVID-19, and a footage of a certain Mario Marcos speaking about meeting with government officials in Indonesia.
Another YouTube video uploaded on June 2 bore the title “FABUNAN ANTIVIRAL INJECTIONS APPROVED SA INDONESIA clinical trials?” When shared on July 22 on FB group FABUNAN ANTIVIRAL INJECTION SUPPORTERS GROUP, the last two words were not found in the headline.
This 19-minute footage contains a clip also of Mario Marcos telling viewers he is in Indonesia on the invitation of members of the Indonesian Ministry of Health and that a proposal they sent for FAI’s clinical trials in the country has been granted.
These videos are erroneous.
VERA Files Fact Check reached out to the Ministry of Health in Indonesia in June but received no response. Instead, the Embassy of the Republic of Indonesia in the Philippines relayed the ministry's answer to claims regarding the approval of a clinical trial of the antiviral drug in their country. It said nothing has been “granted” to the FAI as the makers of the drug still need to undergo a process.
"The process is still long. It’s not that it has not been granted, but nothing has been granted yet...It has not come to the stage where it can be granted because it is still being considered by the (Indonesian) FDA,” an embassy official said in a phone interview on July 7.
The embassy also confirmed the meeting between FAI’s makers and Indonesia’s health officials but said the health ministry did not expound on how the group applied for clinical trials.
Indonesia’s FDA, locally referred to as Badan Pengawas Obat dan Makanan or Badan POM, is coordinating with their Ministry of Health on studying potential treatments for COVID-19.
In Manila, a June 17 press release by the Department of Health says FAI has not yet applied for any drug trials under the FDA, the agency tasked to ensure the “safety, efficacy, purity, and quality” of medical and food products in the country.
In an interview last April, FDA Director Eric Domingo told VERA Files that when Marcos visited his office on April 7, he gave him “guidance” on the proper procedure in applying for a license to operate as a drug manufacturer, and the process and requirements needed for product registration. (See VERA FILES FACT CHECK: Posts claiming PH has ‘approved’ COVID-19 cure FALSE)
The FDA issued a press statement on April 8, saying “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.”
According to an FB post from May 25 by the Fabunan Medical Clinic, the health center has closed its operations a day after the FDA issued a Cease and Desist Order prohibiting the use of FAI.
During a press briefing on May 30, Presidential Spokesperson Harry Roque said he received a letter from an Atty Fabunan to review the FAI, and he forwarded this to Secretary Fortunato Dela Peña of the Department of Science and Technology (DOST).
"The Fabunan drug has not been approved...Before the public is given any type of medicine, including the FAI, it is important that it has to be registered with the FDA. Now, there is a cease-and-desist order against FAI from the FDA because there have been no clinical studies, which can ensure that the new medicine will not pose risks to our citizens," he sid.
The inaccurate videos have been viewed over 10,000 times.