The Department of Health (DOH) said it is not procuring the antiviral drug Remdesivir being used by coronavirus disease (COVID-19) patients.
Health Undersecretary Maria Rosario Vergeire said that the DOH does not have a procurement for Remdesivir because it has no certificate of product registration (CPR).
“We will not do that because we follow regulatory protocols,” she said in a virtual forum Monday, May 10.
In a statement, the DOH also denied allegations that it had purchased P1 billion worth of Remdesivir.
The DOH clarified that while it had initially planned to procure Remdesivir and other investigational drugs, the said procurement did not push through.
“For DOH to be able to procure these investigational drugs, a Certificate of Product Registration (CPR), or an Emergency Use Authorization (EUA) is needed. As such, the procurement could not proceed as none of the investigational drugs have been granted these requisite regulatory approvals during the time of procurement,” it said.
“Despite this, a number of DOH hospitals, including specialty hospitals in NCR, Central Luzon, and CALABARZON, were able to secure Compassionate Special Permits (CSP), which allowed them to procure these investigational drugs even without CPR or EUAs,” added DOH.
The CSP is a special permit that allows institutions to avail of unregistered drugs and devices and use them under certain conditions.
To ensure continued access to promising investigational drugs, especially when experiencing a surge in COVID-19 cases, the DOH said, funds of around P3 to 5 million were downloaded to these authorized facilities for the procurement of COVID-19 therapeutics.
The DOH also explained that the continued use of Remdesivir for COVID-19 patients of certain disposition is “fully supported” by a consensus panel of 19 medical societies as reflected in the Philippine COVID-19 Living Recommendations.
“Moreover, the Health Technology Assessment Council (HTAC) will release a list of recommendations for investigational drugs to provide guidance on the government’s possible procurement of these therapeutics,” it said.
The DOH assured the public that the Department is at the forefront of ensuring that COVID-19 investigational drugs and medicines are safe and effective for use.
A lawmaker on Sunday warned that DOH officials may face criminal charges if they insist on procuring further supplies of Remdesivir despite the World Health Organization (WHO) recommendation against the drug’s use in COVID-19 patients.
Meanwhile, the DOH said the anti-parasitic drug Ivermectin may now be used as “off label” drug versus COVID-19.
This in view of the FDA’s granting of a CPR to Lloyd Laboratories for the manufacture and sale of Ivermectin.
“When we say there is a CPR for Ivermectin, it means it can be used as indicated or for parasitic infections,” said Vergeire.
“Also, if a drug has a CPR already, it can also be used as an ‘off label’ drug. That is part of our regulatory protocol. A doctor has to prescribe this as an ‘off label’ drug before a patient can use it based on the indication stated by the doctor,” she added.
But Vergeire said doctors are accountable for their patients if ever they will allow the use or prescribe it to their patients.
“They should be able to do this kind of monitoring for their patients so they can be sure it is safe for them,” she said.
Vergeire added that manufacturers are also expected to monitor those using their drug products.