FDA faces scrutiny over delays in critical medicine approvals

ARTA Secretary Ernesto Perez

The Anti-Red Tape Authority (ARTA) is setting its sights on the purported concern behind the majority of complaints lodged against the Food and Drug Administration (FDA), the agency facing the highest number of grievances.

During a business forum on Wednesday, March 5, ARTA Secretary Ernesto Perez said the agency had received 25,197 complaints as of the end of January, of which 24,932 or 98.95 percent had been resolved or referred to other agencies.

Perez told reporters that under the previous administration, agencies such as the Land Transportation Office (LTO), the Land Transportation Franchising and Regulatory Board (LTFRB), and the Social Security System (SSS) were the top receivers of complaints.

He said these agencies have improved drastically as the Marcos administration doubles down on its ease of doing business agenda. 

With the FDA getting the most complaints, Perez said this ultimately boils down to its slow action regarding “emergency medicines that are critical to the country's public health system”.

FDA, the health regulatory agency responsible for granting authorizations to manufacturers and distributors of health products, was flagged for causing “many delays”.

Perez said ARTA has already issued show-cause orders to the FDA’s evaluators for the glut of pending applications they have yet to act on.

“So we're waiting for the response to the show-cause orders to the evaluators because our real assessment there is that the problem really lies with the assessment and evaluator side,” he said.

The official cited the FDA’s exclusion of the pre-assessment phase from the standard processing time as the culprit behind the delay.

Based on an FDA advisory, the pre-assessment stage is when evaluators review the submitted application and documentary requirements of those applying their health products, with regard to their completeness and correctness.

A point of contention in this matter, according to Perez, is that the FDA does not include this stage for the prescribed processing time as indicated under the 3-7-20 policy.

To recall, simple transactions must be completed within three days, complex transactions within seven days, and highly-technical transactions within 20 days.

The ARTA chief said the pre-assessment phase, once implemented in the end-to-end process, should be finalized within three days.

With the goal of resolving the issue, ARTA recently conducted a workshop with the FDA to deal with this once and for all.

“We're saying, we're asking, and we will be recommending to FDA to include the pre-assessment in their process. Hindi dapat ‘yun (That should not be) separate,” said Perez.

He added that the ARTA will also assist the FDA in updating its citizen’s charter and further streamlining its process as it undertakes the regulatory impact assessment (RIA).