DOH reverts FDA’s schedule of fees, charges to 2001 rates

Food and Drug Administration headquarters — File photo

MANILA, Philippines — The Department of Health (DOH) heeded the recommendation of the new head of the Food and Drug Administration (FDA) to temporarily suspend the implementation of a 2024 order significantly increasing the schedule of fees and charges of the regulator.

Health Secretary Teodoro Herbosa issued DOH Department Circular No. 2025-040 suspending the implementation of DOH Administrative Order No. 2024-0016 (“Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration”) for 60 working days “or until earlier lifted or further extended by the Secretary of Health.”

The circular, which was dated June 10 but was made public only on June 11, shall take effect immediately.

According to Herbosa, the suspension of AO 2024-0016 and its annexes was “in light of feedback and concerns expressed by various sectors and key stakeholders, and pursuant to an internal review conducted to evaluate operational efficiency, several areas for service enhancement were identified.”

During the period, the schedule of fees and charges, as well as the validity of authorizations shall be in compliance with DOH AO No. 50, series of 2001 (“Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs”), and other applicable issuances prior to the implementation of AO 2024-0016 and its annexes.

However, the fees and charges already paid in accordance with AO 2024-0016 and prior to the effectivity of the circular shall be maintained.

“Applicants who have submitted their applications prior to the suspension of AO 2024-0016 and have not yet tendered payment may request the issuance of a new order of payment consistent with [AO 50, s. 2001 and other previous policies], or opt to proceed with payment following AO 2024-0016,” it added.

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DOH AO 2024-016 was signed by Herbosa in December last year and took effect in January during the term of then FDA director general Dr. Samuel Zacate. In May, Zacate was abruptly replaced by Paolo Teston.

The suspended DOH AO significantly increases the regulatory fees obtaining license to operate (LTO) of FDA-regulated establishments, such as drug manufacturers, distributors, pharmacies, as well as the fees to obtain certifications of product registration (CPRs) for food products, and health products and devices, including medicines and vaccines.

Under this new policy, however, instead of annually renewing the LTOs and CPRs, the fees are now calculated annually and multiplied by the number of allowable years of validity.

The validity of CPRs are also extended from six years in initial registration, to up to 12 years for renewals — an improvement from the previous policy where initial CPRs are only valid for a year, while renewals are valid for only five years.

The rate of fees and charges of the FDA has not been updated for more than 20 years since the implementation of DOH AO 50 in 2001.

In February, the House of Representatives’ joint committees of trade and industry, and health, had been holding legislative inquiries on the implementation of DOH AO 2024-016, assessing if it is in line with the objectives of Republic Act No. 9502 or the Universally Accessible, Cheaper, and Quality Medicine Act of 2008, as well as RA 9711, or the FDA Act of 2009.

Based on its investigation, the then-National Economic and Development Authority (now the Department of Economy, Planning, and Development) did not issue any recommendation on the substantial fee increases being imposed by the FDA.

The FDA also did not conduct appropriate public consultations prior to implementing its proposed increases in January, according to the House joint committees.

The lawmakers also received reports that despite the hike in fees, stakeholders from the private sector alleged that delays hounded the regulatory body, with more than 10,000 applications pending before the FDA.

In a House hearing on May 26, Teston told the committee that he would recommend to Herbosa the suspension of AO 2024-016, saying it needed to be reviewed. He said any increase in regulatory fees of the FDA “must be supported by visible improvements in service delivery and operational efficiency.” /das