Manifestation of Senator Pia S. Cayetano
On the power of the Food and Drug Administration to authorize emergency use of health products
19 January 2021

Part 1

I would just like to confirm Sen. Angara's statement that Section 12 is the special provision that we provided in Bayanihan 2 to address the procurement of the COVID vaccines.

In other words, we specifically put it there to allow the procurement even without Phase 4 trials, because as Sen. Angara correctly pointed out, this is a requirement in the Universal Health Care Law. So without that provision - Section 12 - we will not be able to procure. Siguro, up to next year pa, two years from now. Because Phase 4 clinical trials take a very long time.

So, as I was saying during the past two hearings, what FDA has been asking of us is to cloak them now with authority to grant an authorization - I suppose a certificate of product registration if they want to authorize them - based only on temporary Phase 3 trials, because that's all we have. So let me clarify again that there is also confusion that we have Phase 3 trials readily available. They are not ready. All that is ready are some preliminary data. And countries all over the world have chosen to make their decisions based on the preliminary data of Phase 3. But Phase 3 is not complete anywhere.

I remember asking this question and it was answered... I made that statement but WHO - we can call them again - answered in a way that made it appear that Phase 3 trials have been completed in other countries. They have not been. They are ongoing, but other countries have based their decision to make it available in their countries and issue an EUA based on those tentative or preliminary Phase 3 trial details. And I have seen the results of some being compared, and it's really difficult. Because you'll see merong result na isa o dalawang tao ang apektado out of a few hundred thousands. You cannot make conclusions based on 1 or 2 people who got a side effect. It's very difficult. That's why it takes months and years.

Having said that, talagang the onus is on FDA because, like FDAs all over the world, they will now have that position, which I never want to find myself in, basically clearing a product without the usual studies that they are accustomed to have.

I am not trying to take sides here but I am just trying to let us all see that reality. All over the world, this is the limited data that regulatory agencies are faced with. So they make a choice based on that.

Now, as to the statement of FDA Director-General Domingo, I have not talked to him, I would recommend that he's called into the hearing to clarify this. But I am just surmising that given the donations, similar to what our good colleague, Sen. Tolentino, who gave an excellent presentation of the issues we are faced with, surmised also, that because of diplomatic ties, we may have been constrained to say, "Well, based on Bayanihan law, we have Section 4 that allows the President to authorize the expedient delivery of these products."

He may not be privy, but asking yourself the nuances that we intended that to be the general clause for general health products, but specific to vaccines. I recall exactly the same as Sen. Angara, the Chair of the Committee on Finance, that that is the provision that governed it.

On that note, if I may, with your indulgence, dear colleagues, I just want to also put on record that hindi naman tayo nagkukulang sa experts. FDA, their job is to evaluate safety and efficacy. Si HTAC, it's worth noting that they're the ones who are supposed to look at the viability or efficiency of products for government purchase. Yun ang role ni HTAC. So if HTAC would say, angmahal niyan pero mas effective, go worth it. It doesn't matter na mas mahal yan. Or on the other hand, they might say, mas mura nga yan pero anghirap i-transport, so it may not be a good purchase. So sila ang nagbibigay nang ganung klaseng advice. Plus, they also weigh in to ensure that there are no political and commercial biases. I don't know. They might have a say here kasi that's their specific role mandated by law. And then we have the vaccine experts panel. Their job is to review all applications for studies. It was in the news a few days ago that we have agreed - I think yesterday - to have Sinovac studies conducted here. So I am assuming that the vaccine experts panel had a say on that. They decide, is it ethical, may potential ba talaga yan, or is it not worth our effort to pursue it? And then there's another agency, National Immunization Technical Advisory Group (NITAG). And they're the ones that are very powerful in other countries. They actually track the progress of a vaccine as it's going along.

My point here is, marami talagang experts. I think talagang mahirap for us because we don't even have a doctor in the Senate. Let me apply caution there also. Not any doctor is an expert on this as well. So I think tama lang na in our next hearing, we call on these experts and have them weigh in on it and I'd like to still assume... I think the good sponsor, maybe he can make a quick response. Does he share my observation that to a certain extent, FDA is between a rock and a hard place? Because they do not have the data that they normally would need to make a conclusive recommendation or decision on this. And number two, things are happening fast. Like there are donations, and siya na nga nagsabi na diplomatically, syempre nakakahiya naman sabihin na hindi, pero job din naman talaga ng FDA yan at some point to lay down our processes. But I don't know if maybe out of deference to DOH, tinuro niya yung Section 4.

One last thing, and then I yield the floor to the sponsor once more. The law, RA 3720 that his honor cited, actually has a very general provision that gives authority to FDA to develop and issue standards and appropriate authorizations that would cover health products. So I am assuming that itong EUA na in-issue nila, that they created by way of rules internally, is based on that power. So I just leave that for the body's information and his honor is free to comment on it. But again, I'd like to thank him for a very well researched privilege speech.

Thank you, Mr. President.

Part 2

Can I just continue what the good sponsor was mentioning about Phase 3?

Just for our better understanding, it just so happened that I had asked that question. Phase 1 is volunteers, they volunteer. [Inaudible] those with terminal illness, the doctor will say there is a trial ongoing, so you can volunteer. Phase 2 is small trials. Phase 3 is a large trial and that's where they get the preliminary data, which becomes now the basis of an EUA when something like that is urgent. So in this situation, they used the preliminary data to come up with the EUA. At some point, you have a large enough number of people vaccinated, and so that final data will now form the basis to issue a CPR. And it's after the CPR (certificate of product registration) is issued that's when Phase 4 comes in. So Phase 4, as his honor correctly pointed out, is post-marketing surveillance. So pwede ngang ma-recall, like his honor said. That's when that step would come in. "Nagkamali tayo, pwede pa itong ma-recall." Or they continue or maybe they just post what are the adverse effects. Thank you.#