FDA DIRECTOR GENERAL DR. ERIC DOMINGO

May you share the scope of your responsibility as DG? I make sure that all of our centers are functioning well, because all the complaints are addressed to me. We have five centers—the center for drugs, the center for food, the center for medical devices and radiation, the center for cosmetics, which is also in charge of all the chemicals, toys, household substances, and then we have our laboratory. Of course, there are directors delegated in these departments, but I want to know what is happening in all of our units, how many backlogs we have, and find out what is causing the delay.

During this pandemic, I’m on top of everything that is COVID-related—medical devices, drugs, vaccines, and even essential supplies like alcohol and face masks. I have to make sure that the supplies are there, that our grocery shelves are full, and that the people are not having a hard time looking for what they need because of shortages.

Also big part also of what I do is communicating what the FDA is doing and how it affects what’s happening right now. Kasi kung magtatago ka lang sa opisina mo, hindi mo sasagutin ang mga tanong, nagkukulang din ng impormasyon ang mga tao para i-base yung mga desisyon nila. (If I just hide in my office and don’t answer the public’s questions, they will lack the information they need to make the right decisions.) I try to, as much as I can, communicate to the public and our stakeholders.

How was the past year so far for the FDA?

It’s been very hectic for us at the FDA. It started with the registration of diagnostic kits. These were newly developed technologies, so we had to come up with a registration process for these.

This was followed by the scarcity in alcohol supply. To deal with that, we had to help companies make the necessary shift from producing alcoholic drinks to disinfecting alcohol, to make sure that we don’t run out of supply. During the lockdown, when we had a problem with our food supply, we had to ensure the safety and quality of the imported goods entering the country. Then came the COVID drugs and the solidarity trials that were allowed for compassionate use in the country. We’re currently focused on the clinical trials and the emergency use authorization (EUA) for the COVID vaccines. It’s really non-stop work for us in the department.

What has been the most challenging aspect of your job so far?

It’s really the time pressure. Also the differing opinions of people around you. Yung marami na masyadong nakikisawsaw o nakikialam, o maraming may opinyon dun sa kung anong kailangan mong gawin. Yun minsan mahirap balansehin. (There are too many people who want to meddle in the issue and who have their own opinions as to what should be done. It’s sometimes difficult to balance that.)

What vaccines are being evaluated by the FDA at the moment?

We’ve already granted the emergency use authorization to Pfizer-BioNTech, AstraZeneca, Sinovac, and Gamaleya Sputnik V COVID-19 vaccines. The agency has approved the clinical trial for the vaccines developed by Clover Biopharmaceuticals AUS Pty Ltd., Janssen Vaccines & Prevention B.V. and Sinovac. We’ve received the EUA application for Covaxin by Bharat Biotech of India. The submission is now being evaluated by our regulatory and medical experts.

 What happens is that, once we receive the application, a team evaluates the quality of the product, and another team of experts looks at its safety and efficacy profile. It is a big decision to allow the use of a vaccine that we know is still under development. And the way to assure the safety and quality of the vaccine is to really go through the process meticulously. There should be clear timelines; we can’t afford to do shortcuts. Our experts take their jobs very seriously. Hangang meron silang tanong, hanggang meron silang gustong malaman mula dun sa manufacturer, hinahayaan ko na masagot muna yung mga tanong bago sila makabigay ng mga recommendations nila. (I make sure that all their questions for the manufacturers are answered first before they give recommendations.) But, of course, within a reasonable amount of time.

Why does it appear like the government is insistent on procuring the China-made vaccines instead of what have been reported as the more efficacious vaccine brands?

What I think the government is trying to do is secure vaccines wherever possible, because the supplies are so tight all around. There’s not one brand that could supply us with vaccines for 70 million Filipinos. So they’re looking for ways to find sources that can help supply us what we need.

Perhaps, Secretary Galvez thinks that China will be able to deliver the vaccines right away. I can see that their frame of mind is to have something available and to have a vaccination program started.

How long does it take for the FDA to evaluate and approve a vaccine?

If a vaccine has already been granted an EUA by regulatory authorities in the United States, the United Kingdom, Korea, Japan, and the World Health Organization, the time I give for our evaluators to decide on whether to approve it or not is 21 days.

That’s the time they have to ask all the questions. And then with all the information, make the decision. The time can’t be shorter than that, because our evaluators have to read through all the documents and literature provided by the company. If the EUA applicants lack certain documents we’re looking for, and it takes time for them to submit those, then the process will naturally take longer.

Will you be giving your vaccine recommendations to the government?

What happens is the evaluators give me the recommendation and then I decide whether to grant the EUA or not. Once the EUA is given to a vaccine, that means the government can already procure it and use it in the country’s vaccination program. It is the Department of Health (DOH) that will make the guidelines as to how the vaccines will be used and distributed.

Will there be available COVID-19 vaccines in our hospitals anytime soon?

Not yet, because these products are not yet ready to apply for a marketing authorization or the certificate of product registration. Before the products become commercially available, they need to undergo trials, which take about one to two years. The earliest that the vaccines could be made commercially available would be late 2021 or early 2022. All the vaccines used now around the world are used under an EUA.