Drugstore, pharma firm ordered to stop immunization offer
The Food and Drug Administration has ordered a pharmaceutical company and a drug store chain to cease and desist from promoting and conducting immunization activities in its stores.
Sanofi Pasteur, Inc. and Watson’s Personal Care Stores were told to explain why administrative and criminal cases should not be filed against them for conducting such activities without authorization.
In a statement, FDA director general Nela Charade Puno said the agency did not issue any authorization to allow immunization services to be conducted by Sanofi, Watson’s or any drug store.
“There is no assurance on the safety and quality of the service rendered in these drugstores and thus poses a potential health hazard to the consuming public,” Puno said.
The cease and desist order was issued following Watson’s announcement that it will conduct immunization activities using the dengue vaccine created by Sanofi, Dengvaxia.
A dose of the vaccine costs P 4,000 at the drug store, with three doses to be administered in a year.
In April, the FDA’s Center for Drug Regulation and Research monitored the unauthorized advertisement and promotion of the said vaccine by Watson’s.
The agency noted that the drug store chain misrepresented Dengvaxia as available over the counter despite its classification as a prescription drug approved only for those nine to 45 years old.
The FDA said it will ask Sanofi to explain why they violated the law for the second time.
It may be recalled that in December last year, the agency issued a cease and desist order and also filed a case against the pharmaceutical firm for the unauthorized promotion of Dengvaxia.
Puno warned that if the FDA is not satisfied with Sanofi’s explanation or if the firm continues to commit violations, they will suspend or cancel the vaccine’s certificate of product registration.
“Laws are mandatory and they are meant to be followed. Compliance to the law is not optional, especially when the safety and health of the public are involved,” the FDA chief said.
Puno added: “Sanofi, Watson’s and other manufacturers and drug stores are hereby warned. Nobody is exempt.”
Aside from advising the public not to avail the unauthorized immunization activities in Watson’s branches, the FDA also directed drug stores from conducting immunization activities until the appropriate regulation and appropriate authorization have been issued.
“Regulation action and sanctions shall be strictly pursued in case of non- compliance,” Puno said.
If a drugstore wants to undertake additional services such as vaccination activities, it must apply for variation of its license to operate the FDA.
Among the FDA’s requirement for drugstore-initiated immunizations are: patient counselling, qualification of the person administering the vaccine, dedicated space and sanitation.
Meanwhile the FDA and Department of Health will train and authorize FDA-licensed community pharmacists to administer adult vaccines and other immunization products.
The FDA urged the public to report unauthorized immunizations in drug stores through email, [email protected], or at the FDA’s online reporting facility at www.fda.gov.ph.
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