Senator Cynthia Villar questioned on Wednesday, October 25 the Food and Drug Administration (FDA) and the Bureau of Plant Industry (BPI) for the clinical trials of an African Swine Flu (ASF) vaccine conducted even before it was even approved for commercial use.

Villar made the point during the hearing of the Committee on Agriculture, Food, and Agrarian Reform which focused on the proliferation of ASF vaccines in the black market putting at risk the already beleaguered hog industry.

The senator questioned the clinical trials conducted in six areas in Luzon which were completed since it was recommended for use on June 2, 2023, despite the fact that Vietnam approved the AVAC ASF LIVE vaccine for commercial use only in July 2023.

FDA Deputy Director General for Field Regulatory Operations Oscar Gutierrez stated that they did not issue the authority to conduct the field trials and that BAI is not authorized to conduct the field trials given that the registration for commercial use of the vaccine was disapproved, which is a prerequisite for the clinical trials to push through.

"Kung sila nga na gumawa 'di nga nila na naapprove, tayo mauuna pa? (Even those who created the vaccine did not approve, why will we do it first) Why are we so excited?" Villar asked.

She also asked BAI Assistant Director Arlene Vytiaco if it's true that she's a relative of the ASF vaccine supplier.

Meanwhile, BAI Director Paul Limson argued that there's a clamor to solve the issue of ASF, but Villar replied it should be given the incorrect solution.

"Kinorap ninyo ang BAI, nagpa-corrupt naman ang BAI (You corrupted the BAI and BAI allowed itself to be corrupted),” Villar said.

The senator also found out that the FDA issued authorization to import 300,000 doses of the vaccine for field trials even when Vietnam conducted a clinical trial for only 60 hogs only because BAI requested it.

Villar also questioned why a private company, KPP Powers Commodities Incorporated was the one tasked to conduct the clinical trials, instead of the BAI. Limson said that their role was only to monitor the field trials.

KPP Powers Commodities Spokesman Reynaldo Robles disputed Limson and Viytiaco's claim that they were the ones who conducted the trials and insisted that it was BAI who facilitated it.

Villar, in her opening statement, cited a DOJ opinion saying that the BAI has no regulatory jurisdiction over veterinary drug products and establishments. The authority to regulate veterinary drug products and establishments falls within the purview of the FDA.

"This authority includes the right to inspect, license, register, monitor, and conduct post-market surveillance of drugs, including veterinary drugs, to ensure their safety, potency, and quality," she added.

Villar also said that farmer’s group blames black market vaccines for ASF spread, as of October there are new reports of ASF in Oriental Mindoro, Ilocos Sur, and Nueva Vizcaya provinces, forcing their local government units (LGUs) to declare a state of calamity in their jurisdiction.