Sen. Cayetano laments FDA’s lack of inspectors

Published November 19, 2020, 9:33 AM

by Vanne Elaine Terrazola

Senator Pia Cayetano on Wednesday attributed to the lack of inspectors at the Food and Drug Administration (FDA) its belated discovery of unregistered products.


During the Senate’s plenary debates on the proposed 2021 budget of the Department of Health and its attached agencies, Senate President Vicente Sotto III inquired why it took the FDA three years to find out that the popular liver spread Reno was not registered with the agency.

“According to the reports, the FDA advised the manufacturers of Reno in 2017 when the company secure the license to operate to register the liver spread which was being used already for how many years, ilang taon na (for several years),” Sotto said in his interpolation Wednesday night.

“However, the company did not comply despite the advice. The question is, why did it take the FDA three years to issue the advisory on Reno liver spread that it was not FDA registered?” he asked.

DOH budget sponsor Cayetano, citing her experience as Senate committee on health chairperson for about a decade, said this was the reason that she advocated for continuous funding for the FDA.

“They only had a few inspectors. When I computed, even for drugs, which is very scary — because it’s supposed to heal you and it will cause more problem — hindi pa nila mapupuntahan ng once a year ‘yong mga pharmacy, ‘yong mga fake drugs (they could not even go to pharmacies at least once a year to check for fake drugs),” she recalled.

“So imagine kung pumunta ‘yan sa inyo once, you are assured na hindi ka na babalikan (if the FDA went to you once, you are assured that they will not return anytime soon), because you know they don’t have enough inspectors,” she added.

Earlier in their budget debates, Senator Francis Tolentino also lamented the “sad state of the enforcement division of the FDA” for allowing the distribution of Reno for years without a registration.

But Cayetano said she was informed by FDA Director General Eric Domingo that “they have enough budget” now to hire more inspectors.

“It took how many years for them to catch up with their backlog and they are still doing that. So si Reno ngayon lang naremind (that’s why Reno was just recently reminded),” Cayetano said.

“Most of the catch-up work that they are doing are with cosmetics,” Cayetano said, raising concern over the proliferation of unregistered cosmetic products being sold online.

The FDA discovers 20 to 30 new unregistered products daily, its officials also told senators.

Cayetano also said manufacturers, especially huge and established companies, should be responsible for their products and take it upon themselves to register with the FDA.

“It’s also their duty to register…I agree with you, Mr. President, nakakapagtaka na they have been in existence for decades, namulat na ‘yong mata ko dyan sa liver spread na ‘yan (it’s baffling that they have been in existence for decades, and I grew with that liver spread, but they did not register),” she said, calling out Reno’s manufacturers.

Last September, the FDA issued an advisory against food products that were not registered with the agency, which included Reno.

While it was able to secure a License To Operate, the manufacturer did not have a Certificate of Product Registration (CPR) for the liver spread. The two authorizations are needed before any processed food product can be released in the country’s market, said the FDA.

In October, the FDA announced that Reno already has a CPR.