MANILA – The Food and Drug Administration (FDA) said it recommended the temporary suspension of the new guidelines adjusting fees and charges for facility registration and Certificate of Product Registration (CPR) for health products.

FDA Director General Atty. Paolo Teston made the remark during the joint briefing of the House Committees on Trade and Industry and Health on Monday.

Teston pointed to Administrative Order 2024-0016, which states that fees will be calculated annually and multiplied by the number of allowable years of validity.

"After due deliberation of the management committee of the FDA held last week, the FDA has recommended last week to the Secretary of Health the temporary suspension of the AO [administrative order] pending review of some of its items by the concerned centers of the FDA," he said.

A sample computation in the AO shows a high-risk food product with a three-year CPR validity will incur an annual application fee of P3,500 which totals to P10,500 plus P105 legal research fee (LRF).

Teston said the recommendation is to suspend the implementation for 60 days, unless sooner lifted or extended upon instructions of Health Secretary Teodoro Herbosa.

"Since the subject policy on the adjustment of the regulatory fees of the FDA is based on an administrative order, it will be effective immediately upon the approval of the honorable Secretary of Health," he said.

Teston said the recommendation was transmitted last week and they will follow up the matter. He said old provisions on the fees will apply for now.

House panel chairperson Rep. Ferjenel Biron lauded the FDA for the move.

"It is very comforting to hear. Last time, during the initial hearing it seems like the prior management refuses to listen. We're happy to hear from the new Director General that FDA is now willing to listen and made a recommendation," he said.

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In a letter dated March 3,2025, the FDA said it will proceed with implementation of the new schedule of fees and charges despite the joint committees' recommendation on a moratorium.

The joint panel emphasized the need for public and stakeholder consultation to avoid or minimize unintended consequences.

"Despite the increase in fees and charges by the FDA, industry stakeholders decried the absence of any palpable improvement in the FDA's services. The exorbitant fees remain a burden to stakeholders since the fees are not commensurate to the services," Biron said.

During the hearing, private sector stakeholders suggested a review of the process, saying payment of fees should be done after assessment of the application.

Teston said they will come up with a recalibrated version of the administrative order, which will include input from the technical working group.

He also agreed with the statement that the increase in fees should not be too much without improvement in FDA services.

FDA earlier said the 'commensurate increase' in fees is needed to be able to align with current innovation in technology and to meet the demands of providing quality and efficient services to stakeholders.

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FDA ON BACKLOGS

In the February 3 hearing, the FDA said the backlogs of permit applications are at 10,000, which includes initial, renewal and the variations. The FDA noted they receive 3,000 applications per month and they have a limited amount of technical evaluators.

Teston said some applications have been pending for two or even up to five years, exceeding the allowed timeline.

FDA said the delays in the approval of these applications have an effect on medicine prices in the market.

Teston, who assumed his post last May 13, said she is aware of the backlogs and is prepared to issue drastic measures to substantially reduce these backlogs.

"I've initiated the review not only for pharmaceutical products. I've initiated review for all products being regulated by the Food and Drug Administration. These include food, medical devices, household, urban hazardous substances and cosmetic products. It's an agency-wide review of the pending applications for market authorization," he said.

Later in the hearing, FDA Director of the Center for Drug Regulation and Research Maria Cecilia Matienzo said the backlogs have been reduced to 3,000.

"Medyo kakaunti na po ito. For initial, I think we have 3,000 nalang po. For variation po natapos na po natin yung backlog until August 2024 and we are working on September 2024 onwards with a target of another three months to finish until January," she said.

Lawmakers were puzzled to hear the number of backlogs was greatly reduced in just three months.

"Is it correct to say in three months since March, April May, naka-7,000 na yung approval ninyo? Tama ba yun? Kasi milagro yata yan na 7,000... Paano niyo na de-clog ang CDRR ng 7,000 in three months time?," Biron asked.

"Pinipili ho natin yung applications, pinagsama-sama natin yung mga pareho yung produkto, iba-iba lang yung strength. Nilalagay natin sa isang evaluator para mas madali yung proseso rather than iba-iba yung evaluators evaluating the same product with different strength," Matienzo explained.

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As for variation, the FDA official said they also instituted changes in the process.

"If you have more than 10 variation of a product, you will have four different applications wherein they will go to four different evaluators. What we did is to put together the application," she said.

"Kaya napaunti, sa variation sobrang daming variation pwede i-apply... What we did we issued an advisory some time this March. Stating that for all variation applications, there will only be one application regardless of the number of variations to be filed. Kaya ho yung numbers kumonti ho," Matienzo added.

Biron also questioned why some applications for product registration filed this year were approved in one to two months, while others remain pending for several years.

"I received reports of applications filed and paid in 2025 January, February, March. In one month and in two months, na-approve siya. So paano ninyo ma-explain yun on how you declog the CDRR with pending registrations," the lawmaker said.

"Bago lang siya eh tapos nagkaroon agad ng CPR. I would understand if these are lifesaving products, pero hindi eh. Bakit nagkaroon ng approval ang mga derma products in so short a time vis-a-vis those registrations that have been pending there for years," he pressed.

In a letter to the House panel, the Philippine Drug Importers and Distributors Organization Inc. cited their experience that their applications have been re-decked or brought back to step one since December 2024.

"Pharmaceutical companies' applications are mostly on a pending status, and as of now, no movement at all. Many business for pharmaceutical importations and distributions are being affected and facing possible bankruptcy due to the increasing backlogs," the letter stated.

The group pointed out that the AO on the new fees does not mention liabilities of FDA if they are not able to complete the evaluation and approval on time.

Biron also said some foreign companies and investors end up pulling out due to the delay in the CPR approval.

The House panels asked the FDA to submit a detailed list of pending applications from 2022 to 2025 and a report on how they were able to de-clogged the backlog of applications not later than June 3, the final hearing of the committee.

Meanwhile, the Philippine Chamber of the Pharmaceutical Industry called for more support and to strengthen local manufacturing.

"We face challenges that hinder competition and growth, including disadvantages compared to foreign companies that no longer manufacture products in the Philippines," it said in a letter.

Among the proposals is the provision of green/express lanes for the registration of locally manufactured products, equal regulatory treatment between local and foreign manufacturers, as well as tax incentives on locally created medicines and raw materials needed by manufacturers.

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