House of Representatives. INQUIRER file photo / Niño Jesus Orbeta
The House committee on good government and public accountability has urged the Department of Health (DOH) and the Food and Drug Administration (FDA) to review the existing policies and guidelines relevant to the registration, utilization, manufacture, distribution or sale of drug products for coronavirus disease.
Under Committee Report No. 1393, the panel likewise supported the call of medical practitioners to implement structural reforms in the DOH and the Department of Science and Technology (DOST), particularly to strengthen domestic science research capability in the fields of molecular sciences, virology, immunology, and microbiology.
The committee also recommended the institutionalization of the authority of the FDA to issue Emergency Use Authorization (EUA) for medicines that are determined to be crucial, which it currently exercises under an Executive Order.
Last year, the committee conducted an investigation due to what appeared to be unacceptable delays and backlogs that prevented potential COVID-19 medicines from being distributed or utilized in the country. In particular, it questioned why the FDA’s Center for Drug Regulation and Research (CDRR) had an unusual amount of pending applications, despite the fact that the Anti-Red Tape Authority had already previously recommended the mandatory implementation of the Automatic Renewal provision of the FDA Act on the pending renewal applications for License to Operate and Certificate of Product Registration of drugs.
“There is no reason for the FDA, specifically the CDRR, to have a backlog in its license application processing, especially applications that meet the conditions for automatic renewal,” the committee said in its report. Moreover, there are “issuances of the DOH and FDA (that may be seen as) arbitrary, bureaucratic, and inhumane for causing unnecessary delays in the approval and clearance of drugs and therapeutics for emergency use authorization, or for use of drugs under compassionate special permit for COVID-19,” it noted.
The committee likewise questioned the seemingly redundant — and in some cases, conflicting — need for professionals, particularly the Philippine Society for Microbiology and Infectious Diseases, Inc. (PSMID), to govern the Compliance Policy Guidelines (CPG) for COVID-19 medications. “For a drug to be eligible for emergency use, the PSMID has to recommend the need for it. This raises concerns that the PSMID may have excessive influence over the policies issued and decisions made by the DOH,” the report pointed out.
Based on these findings, the committee determined that Health Secretary Francisco Duque III, former Food and Drug Administration (FDA) Director General Eric Domingo, and CDRR Director Joyce Cirunay were ultimately accountable for these lapses, as well as their possible “failure to render government services such as approval of applications for automatic renewal within the prescribed time.”