Senators sound alarm over alleged FDA anomalies

PHOTO: Food and Drug Administration (FDA) official facebook page

MANILA, Philippines – Several senators on Thursday aired a marathon of complaints against the Philippine Food and Drug Administration (FDA), alleging the agency’s favoritism for big companies and years-long delays in its renewal processes.

During the Senate plenary session on the proposed 2023 national budget, Senator Risa Hontiveros was first to raise a complaint that her office had received against the FDA.

She said there were people claiming that the FDA was “giving undue advantage to foreign manufacturers and distributors of household urban hazardous substances and pet care products.”

“Ang nirereklamo ng ating local micro, small and medium enterprises (MSMEs) ay pinahihirapan o nahihirapan silang makakuha ng certificate of product registration (CPR) mula sa FDA,” the senator added.

(The MSMEs were complaining that they were being given a hard time or encountering difficulty in securing a CPR from the FDA.)

Hontiveros cited that the complaint also flagged the FDA’s supposed lack of institutional support to local MSMEs “to ensure ease of doing business and access to publicly funded product testing facilities.”

Senator Pia Cayetano, who sponsored the budget of the FDA as an attached agency under the Department of Health (DOH), said a visual with a written explanation will be furnished to Hontiveros to explain the standard and process for granting CPRs.

For the product testing, Cayetano said “FDA works with the [Department of Science and Technology], who has the testing labs.”

‘Graft-ridden’

Senator Raffy Tulfo also pressed the FDA for allegedly asking companies to pay from P5 million to P20 million to fast track the renewal of their CPRs.

“Kapag nag-renew ng produkto ang isang pharmaceutical company, kailangan maghintay sila ng up to three years or sometimes, five years at dito po kasi, nagiging open to corruption itong sobrang haba na paghihintay,” he said, similarly citing complaints he has received about issues in the FDA.

(When a pharmaceutical company renews a product, they need to wait three to five years, and this long wait opens the window to corruption.)

FDA director general Samuel Zarate said Tulfo’s claims were appalling but he assured the senator that this practice is not something they tolerate in the FDA.

He, however, admitted that there is indeed an alarming backlog in the systems of the FDA.

This, Zarate noted, is completely addressed by 2023.

“Now those allegations, I cannot tolerate that. I will guarantee you that I will eliminate anything that is outside my principle of public service. I will guarantee you that,” he said.

Tulfo then claimed that it was the previous FDA director general, Sherry Puno, who admitted to him that the agency was “graft-ridden.”

He further insisted: “The more delay, the more money can be asked from the manufacturer.”

“Huwag kang magmalinis. At huwag mong sabihin na malinis ang inyong ahensiya. Just accept the fact na maraming problema diyan sa FDA. Can you do something para linisin iyan?” the neophyte senator said.

(Don’t dare exalt your pride. And don’t say the name of your agency is clean. Just accept the fact that there are mounting problems in the FDA. Can you do something to fix that?)

Zarate revealed that he, too, has heard about the alleged irregularities in FDA operations.

“But the problem is, I do not have leads. Now, I’m telling you. I really won’t tolerate those things. So I want to coordinate with people that have knowledge regarding the corruption in my agency,” he said, speaking in a mix of English and Filipino.

He also vowed that his office would be open 24/7 to receive complaints of such nature.

In view of the claims of corruption within the FDA, Tulfo said he will be keeping a watchful eye on the agency.

But this was not the first time Tulfo raised alarm about the alleged chronic bribery in the FDA as he had already mentioned this during the Senate finance panel deliberations on the proposed budget of the DOH for next year.

READ: ‘Bribery’, ‘conflict of interest’ plaguing FDA, says Senator Tulfo citing ‘sources’ 

FDA budget

Later on at the plenary, Senate Minority Leader Aquilino Pimentel III pointed out that the FDA budget is lodged under the DOH Office of the Secretary.

He then inquired about how this link manifests in the performance of the FDA’s duty.

READ: Lawmakers want FDA to be independent from DOH 

Echoing information from DOH representatives, Cayetano said FDA’s decisions as regulator can be appealed to the Office of the Secretary.

FDA’s policy decisions will also need the input and approval of the department, she added.

As for complaints against the FDA, Cayetano said it can likewise be raised to the DOH.

“They will also look into it and work with them. The [health] secretary and her team are very much aware also of the general issues that have hounded FDA for the past years. In fact, most of us in the Senate know those issues as well,” she said.

Currently, the seat of the DOH secretary remains unfilled, months after President Ferdinand Marcos Jr. took highest post in the country. But he has since designated undersecretary Maria Rosario Vergeire as its officer-in-charge.

Despite the alleged errant practices in the FDA, the proposed DOH budget for 2023 – the third biggest among all government agencies – was still approved by the Senate.

RELATED STORIES: 

Groups urge DOH, FDA to stop asking funds from foreign groups trying to sway PH policies 

Duterte fires FDA chief Nela Charade Puno over alleged corruption 

JPV