Press Release
October 25, 2023

Tolentino warns FDA of breaking laws amid ASF vaccine field trials

MANILA -- Senator Francis "Tol" Tolentino warned the Food and Drug Administration (FDA) that it violated laws in delegating its function to Bureau of Animal Industry (BAI) to facilitate the field trials of African Swine Fever (ASF) vaccine.

During the motu proprio inquiry conducted Wednesday by the Senate Committee on Agriculture, Food and Agrarian Reform on the unauthorized sale of ASF vaccines that are still on trial phase, Tolentino asked, "Ang FDA ang involved dito. Papaano ka magpapasok ng vaccines, ng gamot, ng walang permit ng FDA for a small universe of swines and piglets?"

"FDA should be involved and puwede kayong kasuhan dito ng negligence na rin for not performing your [functions]," he added.

This was affirmed by the Department of Justice (DOJ), saying that FDA has the jurisdiction on the ASF vaccine field trials in accordance with the 1991 Memorandum of Agreement with BAI.

"Kahit po may MOA dati, sa batas po natin, it is still the Food and Drug Administration. The Food and Drug Administration cannot delegate its function to other agencies, even in BAI. Only Congress can delegate those functions. It is non-delegable," Tolentino remarked.

"In the same manner as the Food and Drug Authority cannot delegate it to a private entity. Hindi puwede iyon," he further added.

The lawmaker reminded the agencies: "Ang atin pong ginagawa rito ay makakuha ng lunas dito sa ASF, tama po iyon. Pero dapat po tamang proseso."

Sen. Tol likewise asked the DOJ for the list of violations committed by the FDA.

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