DOH says use of Remdesivir needs ‘compassionate special permit’ from FDA as Manila buys 2,000 vials

The Manila city government has purchased 2,000 vials of Remdesivir, a drug used to treat coronavirus disease 2019 (COVID19) patients. 

Manila Mayor Francisco “Isko Moreno” Domagoso on Thursday said the antiviral drug can be used to treat close to 200 of the city's COVID-19 patients with mild, moderate, and severe symptoms. 

A staff member shows a case of Remdesivir manufactured in a lab of Eva Pharma in Giza Province, Egypt, on July 2, 2020. (Xinhua/Ahmed Gomaa / MANILA BULLETIN)

But the Department of Health (DOH) on Friday said COVID-19 patients who intend to use Remdesivir should first secure a “compassionate special permit” from the Food and Drug Administration (FDA). 

In a press briefing, Health Undersecretary Maria Rosario Vergeire said the use of Remdesivir should be guided by a physician. 

“Ginagamit lang ang Remdesivir sa hospital, unang-una. Pangalawa, dapat guided by a physician. Pangatlo, ang magre-request ay ang doktor, hindi po tayo basta sparingly magbibigay niyan. Dadaan sa regulatory process (First of all, Remdesivir is only being used in the hospital. Second, it should be guided by a physician. Third, the one who will request for it is the doctor, we will not just sparingly give that. It needs to go through the regulatory process),” said Vergeire. 

Vergeire made the statement when asked about the move of the city of Manila to acquire 2,000 vials of Remdesivir for the treatment of their COVID-19 patients. 

“Hindi natin pipigilan ang pagbili ng iba’t-ibang LGUs (local government units) ng Remdesivir para sa kanilang constituents pero dapat tama ang paggamit (We will not stop the LGUs from purchasing Remdesivir for their constituents but it must be used correctly),” she stressed.

 “Ang process natin ngayon, kapag ginamit ang Remdesivir outside of the clinical trial that we have right now, kailangan may compassionate special permit (In our process, when using remdesivir outside the clinical trial that we have right now, it requires a compassionate special permit),” she added. 

The antiviral drug is one of the investigational medicines included in the World Health Organization (WHO) Solidarity Trial, of which the Philippines is a participant. 

The physician should also report to the FDA if the patient is experiencing any adverse reaction, said the Health official. 

“Isa sa conditions diyan, magrereport kayo sa FDA ng any adverse effects na nangyari sa pasyente sa paggamit nitong Remdesivir o kung ano mang off-label drugs na ginagamit ngayon outside the clinical trials (One of the conditions is that you will report to FDA any adverse effect on the patient in using Remdesivir or any offlabel drugs currently used outside the clinical trials)," said Vergeire. 

‘Positive feedback’ 

Although it is not a guaranteed cure for the disease, Domagoso said there are studies that show it can help speed up recovery of COVID-19 patients. 

Food and Drug Administration (FDA) Director General Rolando Enrique Domingo recently said there is "positive feedback" on Remdesivir, based on the initial results of a World Health Organization (WHO)-led Solidarity Trial. 

The medication reportedly reduced the length of illness from 15 to 11 days, Domingo said, citing the results of the trial where experts attempt to find an effective treatment for the disease. 

"Medyo panatag ang loob ko na – hopefully – mas marami pang mag-survive sa COVID-19 kapag sila ay mayroon na (I feel assured that, hopefully many more survive COVID19 when they get the medicine)," Domagoso said in a live broadcast. 

The local chief executive said administering Remdesivir to patients is another bid to boost their fight against the pandemic. 

"As we promised you, we will continue, in our own little way, na palakasin ang ating medical institution at i-empower ang ating mga doktor, mga nurse, and other medical frontliners (to strengthen our medical institutions and empower our doctors, nurses, and other medical frontliners)," he said. 

"So that we can give more confidence to our doctors and medical health workers that, we are not only buying machines, building facilities, testing patients, placing them under quarantine, contact tracing, and conducting surveillance, we are also buying medicine that can possibly help patients recover faster," he said in a mix of Filipino and English. 

Around ₱13 million was spent to procure Remdesivir from Mylan, the pharmaceutical firm that created the drug. 

The Manila mayor said they were able to buy each vial for ₱6,500, lower than its original price of nearly ₱20,000. 

Vice Mayor Honey Lacuna-Pangan, a doctor, said the medication is not available over-the-counter and was distributed to the city's six district hospitals – the Gat Andres Bonifacio Memorial Medical Center in Tondo, Ospital ng Tondo, Justice Jose Abad Santos General Hospital in Binondo, Ospital ng Sampaloc, Ospital ng Maynila Medical Center in Malate, and Sta. Ana Hospital. Domagoso said they will acquire more vials if needed. 

"Kung saka-sakali kakailanganin pa, bibili pa po tayo, mapangalagaan lang namin kayo, mapataas lang namin ang probabilidad na kapag kayo ay na-infect ng COVID-19, kayo ay mag-recover (If needed, we will buy more so we can take care of you, just so we can increase the probability that you will recover if you get infected with COVID-19)," he said. 

The Manila city government earlier earmarked a budget of ₱200 million for the purchase of COVID-19 vaccines once they are available. Manila city government data shows that as of Aug. 11, there are 5,544 confirmed COVID-19 cases in Manila with 4,293 recoveries, 246 deaths and 1,005 active cases.