The House of Representatives has approved a committee recommendation for the filing of administrative charges against Health Secretary Francisco Duque III and former Food and Drugs Administration Director General Eric Domingo over their alleged failure to “render government services” extremely needed for government’s response to the 2019 coronavirus disease pandemic.
Approved during regular session on Tuesday, Jan. 25 was Committee Report No. 1393 submitted by the Committee on Good Government and Public Accountability that conducted a congressional inquiry into the DOH and FDA policies and guidelines for the “registration, utilization, manufacture or sale of drug products for the coronavirus disease.” The House panel chaired by DIWA Partylist Rep. Michael Edgar Aglipay examined whether or not the said policies and guidelines were detrimental to public interest as directed under Resolution No. 1711.
“The resolution cited issuances of the DOH and FDA as having been questioned for being arbitrary, bureaucratic and inhumane for causing unnecessary delays int he approval and clearance of drugs and therapeutics for emergency use authorization or for use of drugs under compassionate special permit for COVID-19,” the committee report stated.
The House panel resolved issues raised during the series of hearings, one of which was the possible liability of DOH and FDA for issuing contradictory guidelines and directives and for relying solely on a panel of experts comprised of a handful medical professionals.
The good government committee also determined whether or not the FDA had indeed failed to implement measures to streamline its processes, thus resulting in registration backlog and violation of Republic Act No. 11032 or the so called Anti-Red Tape Act.
Aglipay’s committee found that Duque and Domingo have violated Section 4 of Republic Act No. 6713 or the Code of Conduct and Ethical Standards for Public Officials and Employees”.
The lawmakers also recommended the filing of charges against Duque, Domingo and Director Joyce Cirunay of the FDA Center for Drug Regulation and Research (CDRR) for violation of RA 11032. or ARTA.
The committee said the three officials have failed to “render government services such as approval of applications for automatic renewal within the prescribed time.” This refers to the backlog of license applications, especially those meeting conditions for renewals” for License to Operate and issuance of Certificate of Product Registration of drug companies pending before the CDRR.
DOH was cited for recommending the use of investigational drugs for clinical management of COVID-19 cases. Among these were Remdesivir, Hydroxychloroquine, Lopinavir-Ritonavir and Tocilizumab.
But the committee pointed out that the World Health Organization (WHO) has come up with “categorical recommendations” against the use of some of the drugs which are hydroxycloroquine, Lopinavir-Ritonavir and Remdesivir.
The controversy over the use of Ivermectin for COVID-19 infection was also raised as both DOH and FDA questioned its effectivity and safety.
While Ivermectin makers are still unsuccessful in convincing international health experts about its efficacy, several solons, including those who initiated the probe, aired the observation that several countries had already allowed the use of the drug for COVID-19 treatment.
Further the committee also noted what it described as “seeming bias” of DOH and FDA towards the Philippine Society for Microbiology and infectious Diseases (PSMID) that recommended the clinical practice guidelines allegedly adopted by the government on the entry and use of investigational drugs and treatment for COVID 19.
“There appears to be no review done, considering the DOH officials, in the words of Secretary Duque himself, were not experts in the field of infectious diseases and as such, the DOH appeared to be at the mercy of PSMID as they relied solely on the statement of PSMID panel of experts,” the House panel stated.
Aglipay’s committee stressed: “This presents a great danger considering most clinicians simply adhere to the recommendations of the DOH which is of course accountable to the people for the polciies and issuances it lays down.”
“The current working relationship between the DOH and the PSMID appears to be doing the country more harm than good. The highly conservative stance of the PSMID against allowing investigational drugs in the clinical treatment of COVID-19 may have unintentionally barred the entry and use of other drugs that may be effective against COVID-19 such as Vitamin C, Zinc, and Ivermectin,” the committee said.