UNAUTHORIZED FDA DISCRETION
By Sen. Francis "Tol" N. Tolentino

Thank you, Mr. President. Magandang hapon po. I rise on a question of personal and collective privilege.

Yesterday, following the speech of my kababayan, Sen. Ping Lacson, Sen. Bong Go delivered a quick manifestation. Thereafter, Sen. Lacson, before yielding the floor asked Sen. Bong Go a question. Where do we secure lethal injection drugs? The question ended without an answer. I proceeded to the seat of Sen. Lacson, and gave him my answer which I am about to complete today, Mr. President.

Ang sabi ko po kay Sen. Lacson, ang mga gamot po na pang-lethal injection ay galing sa Mexico. I cite a case, Mr. President, Cook v. Food and Drug Administration of the United States (733 F.3d 1 [D.C. Cir. 2013]). This has something to do with a doctrine and to show how strict and how reliable the US FDA is, and I will compare this situation later with the Philippine FDA.

The Doctrine of Unsafe for Human Execution came about in that Cook case. Ang nangyari po, Mr. President, merong mga preso sa Arizona, California, at Tennessee. Sila po ay malapit nang i-execute subalit kagaya ng napag-usapan naming ni Sen. Lacson kahapon, magaling po yung abogado nila. Ang ni-raise po nila sa U.S. Supreme Court, ay yung issue po ng Sodium Thiopental. Sodium Thiopental is an anesthesia, and a convict would thereafter be injected with Pancuronium Bromide, which causes paralysis, and thereafter, Potassium Chloride, which stops the heart.

But the issue, Mr. President, is that the lawyers of these prisoners were able to stop and delay the execution, because the drug Sodium Thiopental has no emergency use authorization (EUA). It was not yet authorized by the US FDA for use. So there came the Doctrine of Unsafe for Human Execution. Makakamatay daw yung drug kaya huwag muna gamitin pero yung drug gagamitin talaga para sa lethal injection.

I now go to my point, Mr. President. Yung US FDA where we followed and copied almost verbatim the provisions of our FDA Law, ay nakakalungkot, and I mentioned this several months ago in my speech concerning the IRRs. Ito na naman po tayo, Mr. President. During the hearings conducted by the Committee of the Whole, and I'm not demeaning the FDA, they are trying to do their best but I think they are utilizing their functions in an inappropriate manner. That's why this is speech is entitled, "Unauthorized FDA Discretion," Mr. President.

Ang pinag-usapan po natin noong Committee of the Whole ay kung pwede po ba ang local government units at ang private sector na bumili ng sariling bakuna. Mr. President, prior to 14 December 2020 or 35 days ago, the FDA issued several circulars allowing, in my reading, and this is my submission, procurement by the private sector, and non-government-controlled or centralized procurement of vaccines.

I am referring to several issuances issued by the Food and Drug Administration: FDA Circular 2020-12-A, dated 27 July 2020; FDA Circular 2020-12-B, entitled "Further Amendment to FDA Circular 2020-12 entitled Guidelines for Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)," dated 26 August 2020; and thereafter, FDA Circular 2020-036, entitled "Guidelines on the Issuance of Emergency Use Authorization" dated 14 December 2020.

Mr. President, prior to the cropping up of the word, "Emergency Use Authorization," which is now being widely used, the mantra of the FDA from the circulars that I mentioned, refers to drug products under emergency use. Hindi po nila ginagamit yung Emergency Use Authorization. Wala po yan sa batas, Mr. President. Wala po yun sa RA 9711. Wala po yun sa RA 3720, the original act creating the Food and Drugs Administration, Mr. President.

These words, emergency use authorization, as I mentioned a while ago, cropped up following the issuance of Executive Order No. 121 coming from Malacañang, but if we take a look at Executive Order 121, it does not limit the procurement of vaccines to the national government, Mr. President. Ginawa lang po ito ng FDA, binago nila yun. They issued before several circulars, including the circular that mentions Marketing Authorization Holders to show that they allowed before the procurement by the private sector, the local governments and other entities.

But 35 days ago, on 14 December 2020 to be exact, they issued a circular amending everything. They issued a circular mentioning for the first time Emergency Use Authorization which, Mr. President, I have a copy here, would show that it never even mentioned a centralized procurement system.

So what is happening now is that the FDA issued circulars, left and right, and thereafter belatedly amended its circular to include the words "Emergency Use Authorization." It then interpreted its own circulars which it would implement. I am not trying to demean the FDA but now it appears that the FDA is now the legislator, executive, and judge as the sole interpreter of the circulars it issued.

Mr. President, this is really a classic case of undue delegation of legislative powers. Ito po yung sinasabi ko na baka naman nasobrahan na. We are not just dealing with an ordinary product. I've mentioned this during the budget hearing. How come they are now so strict, enforcing their own crafted Emergency Use Authorization for a product that is being utilized in other countries when they have been reluctant to enforce their own rules here?

I've mentioned this during the budget hearing. For several decades, we have been ingesting Reno liver spread without a Certificate of Registration coming from the FDA. We have been using Tiger balm without a certification coming from the FDA. They just issued the certifications last year. And I just found out and the websites would confirm this, that even our widely used Pantene shampoo variant has not been issued an FDA certificate. Bakit sobrang higpit nila doon sa produktong pwede namang bilhin ng local government units at ng private sector, pero itong mga ginagamit na natin ay ayaw nilang higpitan?

Mr. President, I'm citing all of these including several provisions of the IRR of the FDA. Ang nakalagay po sa batas, Republic Act 9711, the FDA Director General can issue and exercise the power of contempt. Pero sa ginawa po nilang IRR, any official of the FDA can have the power of contempt.

So again, that's a clear example or a classic example of FDA violating the law, issuing their own laws, interpreting their own laws, and implementing their own laws, Mr. President.

After this pandemic, we should take a look at the regulatory regime where the FDA exists. It's about time that we reform the regulatory regime. It's about time perhaps that we transfer the FDA to the Department of Science and Technology or clearly delineate its functions in such a way that they will not deviate from what is enumerated in the law.

I have a lot of things to say here but it pains me, however we look at it. The oldest circulars have no legal basis. This is the submission of this representation. The FDA cannot prevent other sectors from acquiring the vaccines based on their misplaced interpretation of a ruling they crafted which is not pursuant to the laws given by the Congress.

To end, Mr. President, again I do not mean to cast aspersion on the motives of the FDA. Kailangan po natin silang tulungan. Baka lang hindi nila naintindihan yung bakuran ng kanilang kapangyarihan. The FDA, right now, is trying to give validity to their own circulars. The FDA, to make their own circulars valid, would depend on the readings of events still in the womb of time. A forecast that is the outcome of forces at best appreciated only with the knowledge of topmost secrets of highly developed nations and elite drug laboratories is to give our local FDA too much discretion beyond the powers that the law gave them, Mr. President. Thank you, Mr. President, for allowing me to mention my piece which should have been a double-headed manifestation yesterday. Maraming salamat po.