In the wake of reports about the rising number of Japanese encephalitis in the country, the Food and Drug Administration has been alerted about JE vaccines being peddled by unauthorized dealers or retailers, many of them online.
The FDA quickly issued an advisory (No. 2017-265) to warn the public against availing of vaccines being sold by online sellers - through social media and other websites - as well as distributors or retailers not sanctioned by the agency.
“Consumers availing from these unauthorized distributors or retailers are at risk of buying vaccines of poor quality, compromised by non-compliance to the required standards of FDA, or worse, at risk of buying counterfeit products,” the FDA wrote in its advisory.
Law enforcement agencies, as well as all local government units, have been tasked by government to ensure the sale of such products are halted.
The FDA cited Republic Act No. 9711, which states that all establishments meaning to sell vaccines and other drug products must secure a License to operate or authorization from FDA before entering into transactions involving drugs.
“The FDA has already initiated the conduct of regulatory actions together with concerned marketing authorization holders on the proliferation of vaccines being sold or offered for sale online and from other unauthorized distributors or retailers,” the FDA added.
As of August 26, the Department of Health reported that there were 133 JE cases, which is 50 percent lower compared with the same period last year. Last year's tally was at 273 cases, according to Secretary of Health Paulyn Ubial.
Meanwhile, the FDA reminded the public that it can validate an establishment’s registration with the FDA by simply typing in the name of the establishment in the FDA search box.
Illicit activities may likewise be reported to the agency via firstname.lastname@example.org, through eReport at www.fda.gov.ph/report or by calling the FDA's Center for Drug Regulation and Research (CDRR) at (02) 809.5596. MIMS