The Department of Health (DOH) reiterated that as of today there are no Food and Drug Administration (FDA) approved medicines or vaccines with an indication for use against COVID-19.
FDA Director-General Rolando Enrique Domingo clarified during the DOH Beat COVID-19 Virtual Presser that there are no drugs or vaccines with an approved indication for the treatment of COVID-19, nor are there any pending applications for it. “Kapag sinabi po kasi natin na ang gamot ay rehistrado or aprubado ng FDA, ibig sabihin, yung gamot po na yun ay nasuri ng mabuti at na-testing para sa partikular na sakit na sinasabi niyang gagamutin niya,” explained DG Domingo.
When asked by Health OIC-Undersecretary Maria Rosario Vergeire on the application process, DG Domingo emphasized that for a new drug to be registered and approved by the FDA, the manufacturer should show proof that the facility and drug manufacturing process, including the ingredients used, is compliant with international standards. This is to ensure that the drug poses no harm to its intended users.
A new drug should undergo extensive clinical trials. DG Domingo further explained that the drug must be initially tested in the laboratory to determine its safety profile before conducting studies in healthy humans and eventually in humans with specific health conditions. This comprehensive research is implemented to ensure patient safety and drug efficacy.
The FDA Director-General also warned the public on the use of unregistered drugs and urged manufacturers to register newly discovered drugs and go through the proper scientific and legal process. “The FDA is encouraging inventors to apply and have it registered so that, if found to be safe and effective, our fellow Filipinos could benefit from it,” Usec Vergerie said.
The use of off-label drugs or medicine administered for a purpose different from its FDA- registered use was also tackled today following the discussion from yesterday’s Beat COVID-19 episode.
DG Domingo emphasized that the FDA does not encourage off-label use of drugs. Patients who are willing to undergo experimental COVID-19 treatment options should discuss this thoroughly with their medical team. An informed consent from the patient must be secured prior to trying experimental medications so that the patient is aware of the possible risks and adverse effects associated with the treatment.
The Department of Health (DOH) has joined the World Health Organization (WHO) Solidarity Trial to contribute to a global evidence-based approach to COVID-19 treatment. This is a large-scale international clinical trial to investigate and identify effective drugs that can be used to treat COVID-19.
Meanwhile, USec. Vergerie advised the public of the ongoing measles immunization services of the DOH despite the COVID-19 outbreak. Children aged 0-12 months may be avail of the Department’s Expanded Program on Immunization in health centers, from Mondays to Fridays. The continuous immunization program is pursuant to Department Order 2020-0150 released on March 25, 2020. Parents and their children are advised to wear masks and practice physical distancing when visiting health centers.
Patients who frequent DOH’s Directly Observed Treatment Strategy (DOTs)-Tuberculosis centers are considered as high risk for COVID-19, and were also advised to communicate with the nurses of DOTs centers for their one month supply of TB Medicine. Family members of TB patients were also encouraged to become treatment partners to monitor the medication and condition of their loved ones.
USec. Vergerie also urged the public not to discriminate COVID-19 patients and survivors. “Napagtagumpayan po nila ang COVID-19. Wag naman po sana nating iparamdam na matapos ang laban nila sa virus ay may panibagong laban na naman silang haharapin,” she appealed. The Department of Interior Local Government and the Philippine National Police are also tasked to protect them from discrimination and harassment. This call following reports of violence and harassment against health workers and frontliners, including COVID-19 patients and survivors./DOH 4/17/20 PR