THE Food and Drug Administration (FDA) yesterday warned the public against the rampant unauthorized selling of molnupiravir amid the surge in coronavirus disease (COVID-19) cases.
In an advisory, the FDA said it would be unsafe and dangerous for consumers to buy the COVID-19 drug treatment sans the required authorization from the agency.
“FDA warns all healthcare professionals and the public on significant risks associated with the growing sales of the drug product molnupiravir in the market,” the FDA said.
“This sudden demand has attracted unscrupulous individuals or organizations from distributing and selling this drug product in the market at a much higher price even without the required authorizations,” it added.
The statement was issued amid the increased demand for the investigational drug product for COVID-19.
The FDA stressed that only an emergency use authorization for molnupiravir (Molnarz) 200 mg capsule has been issued in the country. It said the EUA is not a marketing authorization or a Certificate of Product Registration (CPR).
“Hence, it cannot be used as an authorization to market the drug commercially,” the agency said.
It pointed out that medicine bought from an unlicensed establishment or online cannot be guaranteed as genuine and may contain no active ingredient, too much, or too little active ingredient, which may result in the condition/ailments not being treated correctly.
“Buying medicines in unlicensed establishments or over the internet can pose serious health risks,” said the FDA.
The FDA has strongly advised healthcare professionals, patients, and consumers to access molnupiravir only through proper channels.
This include the Department of Health, which is the national procurer for drug products under EUA, or to hospitals/institutions granted with Compassionate Special Permit (CSP).
It urged the public to report the illicit and illegal distribution and selling of the product.
This can be done via email (report@fda.gov.ph); submitting an eReport (www.fda.gov.ph/ereport); or by calling the Center for Drug Regulation and Research (02-8809-5596).
