One of the busiest government offices in the country today handling the most crucial of tasks is the FDA.
The Food and Drug Administration is responsible for approving all of the country’s Covid-related supplies—from face masks, test kits, and alcohol, to drugs and vaccines. Many of its employees work round the clock to keep up with the tons of products coming in for evaluation and registration. On top of this agency is its Director General, Rolando Enrique “Eric” Domingo.
Domingo is increasingly becoming a familiar face. He’s on TV often lately, answering questions about the moment’s hottest topic: Covid vaccines. The doctor and former Health undersecretary took on the post as officer-in-charge of FDA in 2019 and formally assumed the position as director general March last year, just when the number of Covid-19 cases in the country was starting to rise.
Doctors are duty-bound to save lives, or at least provide treatment, but Dr. Domingo has never been in charge of the fate of so many.
“Since I started [serving as director general], talagang wala pang pahinga,” says the doctor who, before sitting for this interview, had already done two speaking engagements. “Talagang tuloy tuloy [ang trabaho]. Something always comes up.”
Life at the FDA was extremely busy at the onset of the pandemic. There were new products—diagnostic kits for instance—that needed to be registered. They had to make sure there was ample supply of essential goods, such as rubbing alcohol, in the market. When the country encountered an issue on food supply due to the lockdown, the agency had to make sure all imported products coming into the country were safe and of quality. Around June and July last year, when new drugs for Covid were being tried out, it had to find ways to efficiently facilitate the solidarity trials to allow the use of the drugs in the country.
“Ngayon mga clinical trials naman for vaccines. Ang talagang focus namin ngayon is the emergency use authorization (EUA) para sa vaccines para magamit na dito sa ating bansa,” Domingo tells ANCX.
As of press time, Pfizer’s Covid vaccine has been approved by the FDA for EUA. Currently under its evaluation are the AstraZeneca and Sputnik V vaccines. Sinovac has also inquired about the requirements and process, and Dr. Domingo believes “they will apply really soon, I think probably within the week.”
When we sat down with the Director General, we asked him right away why it appears the government is insistent on procuring the China-made vaccines instead of what have been reported as the more efficacious vaccines brands?
Dr. Domingo answers thoughtfully. “What I think the government is trying to do is really to secure vaccines, from wherever possible. Kasi talagang the supplies are so tight all around. Wala kasi talagang isang vaccine manufacturer that would be able to supply us all the vaccines we need. Walang isang brand, for example, na makakapag-supply for 70 million Filipinos. So talagang naghahanap sila ng easily makaka-produce at makaka-supply sa atin.”
The doctor says allowing the use of a vaccine still under development or in the trial phase is a big decision to make, so FDA experts really have to look at the safety and efficacy profile of each of the vaccines.
“The way to assure that is to really go through the process meticulously, with clear timelines, hindi pwedeng mag-short cut,” Domingo says. “Our experts take their jobs very seriously. Hanggang meron silang tanong, hanggang meron silang gustong malaman mula doon sa manufacturer, hinahayaan ko na masagot muna yung mga tanong bago sila makabigay ng mga recommendations nila. But, of course, within a reasonable amount of time.”
For vaccines already given the EUA by countries like the US, the United Kingdom, Korea and Japan, he’s given local experts 21 days to make the decision on whether to approve it for Philippine use or not. What could prolong the process, he says, is if manufacturers failed to submit needed requirements.
Would the approved vaccines be available in the hospitals anytime soon? Dr. Domingo says it will take about one to two years before vaccine manufacturers can complete all its clinical trials. So the earliest that the vaccines can be made commercially available would be late 2021 or 2022. “Lahat ng bakuna na ginagamit ngayon sa buong mundo are being used under EUA.”
A day in the life
“It’s a boring office,” he says, laughing, when asked to describe the daily goings-on at the FDA, a mystery to most. He says the agency is made up of several centers which deal with food, drugs, medical devices, cosmetics, chemicals, toys, and household substances, and the FDA evaluators are tasked to review the clinical trials, as well as the safety and efficacy data. “Basa kami ng basa,” he shares. “So that’s really a lot of the work. And then we have our laboratory that works 24 hours a day.”
They need to have serious focus on the tasks because he is aware of the very demanding and discriminating public. “Pag meron silang makitang product na sub-standard or poor quality, they call our attention to it. And we have to go to that pharmacy or store to check it out,” he says. “Minsan lang talaga hindi namin kaya lahat ng sabay-sabay, but we try to go through everything naman,” he assures. He’s not complaining. These reports only make them work even harder, he says.
Helping him run the FDA offices all over the country are about a thousand people. These include the enforcers that go around checking the unregistered products sold in the market.
As director general, one of his primary tasks is to make sure all their centers are functioning well. Since he’s the one who receives the complaints, he wants to be sure he knows what’s happening in all of their units.
He admits that there are efficiency issues but they are continually being addressed. The centers for food, medical devices, and cosmetics are quite on track, he says, but they still have a huge backlog in the drugs department.
“Nung inabutan ko yan last year, the backlog I think was 18,000 registrations. Now, there are still 11,000, which were applications from 2020,” he says. They are hoping to finally be on track with their schedule. “Kasi sinasabi ko sa mga kasamahan ko, pag maganda yung produkto, pag maganda yung bagong gamot tapos hindi natin sya na-approve agad at hindi nalalabas sa merkado, nade-deprive natin ang publiko sa therapeutic measures that should be available for them.”
Dr. Domingo says he’s very hands-on at the moment when it comes to everything Covid-related—medical devices, drugs, vaccines, even basic supplies like alcohol. Also among his responsibilities are creating and reviewing policies for the organization.
Unlike other government officials, he doesn’t have a spokesperson. “Sa opisina ko, limang tao lang kami, so I do a lot. I answer my own emails, I check everything. Ako na rin ang nagko- communicate for FDA.” This speaks of the kind of boss he is—he works hard so he expects the same from people under him. “I don’t believe in having too many people. Mas gusto ko yung mas konti ang tao tapos punung-puno ang schedule nila. Kasi ganun siguro ang personalidad ko that is why ganun kaming lahat ng team ko.”
To de-stress he tries not to accept any job-related invitations on Sundays. “And I know how to turn it off,” he says. “Usually by 10pm, tulog na ako nyan. I wake up between 5:00 AM to 5:30 AM. I usually go to church early in the morning to start my day fresh.”
He knows not to let the stress of the job get the best of him. “Pwedeng stressful right now, but you let it go and move on once you’re done with what you think you’re supposed to do.”
What it takes to be an FDA chief
Dr. Domingo is known to his peers in the medical profession as a well-grounded man. “Mabait ‘yan at magaling,” says Dr. Benjamin Co, infectious diseases and clinical pharmacology expert (and ANCX’s Covid stats analyst).
An FDA Director should first and foremost be a doctor of medicine, or an allied medical professional with advanced education, says Dr. Domingo, who is an ophthalmologist. He finished his medical degree at the University of the Philippines and took his residency training in ophthalmology at the UP-PGH, before he left for Spain to specialize in eye cancer. Dr. Domingo established the Eye Cancer Specialty Clinic in the state-owned hospital. He’s been in the medical practice for a good thirty years.
“Kailangan meron ka talagang pagkakaintindi sa safety, efficacy at quality ng mga produkto and how it affects the human body,” he says. “And you have to have an understanding of the whole chain. So simula sa production hanggang sa delivery, hanggang sa actual use, at sa pagbantay ng mga possible side-effects sa tao. So important yung technical know-how.”
Equally important are the personal qualifications. It is a given, he says, that a director general should be able to manage his time very well, “kasi talagang hindi mauubos ang trabaho.”
The 52-year-old doctor says he makes it a point not to have personal relationships with the pharma companies (or any company for that matter), so as to not to compromise his and the agency’s position. “Mahirap yung may kaibigan ka [sa pharmaceutical industry] kasi may conflict yun sa trabaho mo, dahil nakasalalay din naman sa iyo yung negosyo nila in a way.”
It’s a thankless job. The most challenging part in fulfilling his role over the last couple of months, he says, is dealing with the time pressure and the clashing opinions of different sectors. “Yung marami na masyadong nakikisawsaw or nakikialam or masyado na maraming opinyon dun sa kung anong kailangan mong gawin. Yun minsan mahirap balansehin,” he admits.
But as FDA director general, he knows he should not give in to pressure and persuasion. There are set parameters the agency adheres to. “At basta naman alam mo na sinusunod mo—safety, efficacy at quality, yan lang naman ang hinahabol para maprotektuhan ang public—hindi dapat nasu-sway ang iyong mga desisyon,” says the doctor. “That, I think, is very important.”