New FDA chief urges suspension of new regulatory fees
Food and Drug Administration director general Paolo Teston. — Photo from FDA
MANILA, Philippines — The Food and Drug Administration (FDA) has urged the Department of Health (DOH) to approve the immediate suspension of an order increasing the regulatory fees for registration and certification of health products amid complaints by the private sector and an ongoing investigation by the House of Representatives.
Newly appointed FDA director general Paolo Teston suggested the suspension of DOH Administrative Order (AO) No. 2024-016, which took effect in January, saying a review of the policy was necessary to “assess certain provisions of the AO in coordination with the FDA’s concerned centers.”
The proposed deferment of the policy shall be effective seven days after approval by Health Secretary Teodoro Herbosa, and shall be in effect for 60 days, unless sooner lifted or extended upon instruction of the DOH chief. The FDA is an agency under the DOH.
In a statement on Thursday, the FDA said that the regulator under Teston, who assumed leadership of the regulating body on May 13, is “adopting a whole-of-government approach to ensure that policy changes remain fair, transparent, and aligned with broader efforts to strengthen healthcare regulation.”
According to Teston, any increase in regulatory fees “must be supported by visible improvements in service delivery and operational efficiency.”
DOH AO 2024-016 was signed by Herbosa in December last year, during the term of then-FDA director general Dr. Samuel Zacate. who was abruptly replaced by Teston. The DOH and the Office of the President did not disclose the reason for Zacate’s removal as FDA head.
DOH AO 2024-016 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 the 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.
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No hike for decades
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, series of 2001.
“With the current innovations in technology and the improvement of the country’s economy as evidenced by the flourishing health product industry, a commensurate increase in the fees and charges is considerably needed to be able to meet and sustain the increasing demands of providing the FDA stakeholders quality and efficient services,” DOH AO 2024-16 states.
Since February, however, the House of Representatives’ joint committees of trade and industry, and health, have been holding legislative inquiries on the implementation of DOH AO 2024-016, assessing if it is in line with the objectives of Republic Act 9502 or the Universally Accessible, Cheaper, and Quality Medicine Act of 2008, as well as the 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 regulator 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 pending applications pending before the FDA.
“The exorbitant fees remain a burden to stakeholders as the increase they pay is not commensurate with the services they receive. Up to the present, the FDA is still swamped with backlogs which translates to delays and gaps in registration and action taken,” Iloilo Rep. Ferjenel Biron, chair of House committee on trade and industry, said during an inquiry on May 26.
He appealed to the FDA to ensure that the benefits of the products that go through the FDA processes be known to the public “in a timely manner at the least possible cost.”
Biron also urged the DOH to urgently suspend its AO 2024-016, saying the agency should have “[evaluated] the potential socio-economic impact of any proposal of the FDA for new or revised rates on the well-being of their respective stakeholders.” /das
