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FDA orders Sanofi, Watsons to stop immunization activities


The Food and Drug Administration (FDA) has ordered a pharmaceutical company and drugstore chain to stop advertising, promoting and conducting immunization activities in Watsons drugstores, noting that both have to show cause as to why they should not face criminal charges.

Sanofi Pasteur, Inc. and Watsons Your Personal Store were not given any authorization to conduct immunization community-based health services, FDA Director General Nela Charade Puno said in an advisory posted on the FDA website.

"As such, 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.

"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. Sanofi, Watsons and other manufacturers and drug stores are hereby warned. Nobody is exempt." he added.

Sanofi will be asked to explain its part on why they have violated the law for the second time. Puno said that once they are not satisfied with the explanation, they "will be compelled to suspend or cancel its CPR (Certificate of Product Registration) for the said vaccine."

FDA in December 2016 issued a cease and desist order along with an administration case against Sanofi for unauthorized promotion of its Dengvaxia vaccine.

"We advise the public not to avail of these unauthorized drug- store initiated activities." Puno said.

For its part, Watsons Personal Care Stores (Philippines) Inc. said it will abide by the FDA order.

GMA News Online is contacting Sanofi Pasteur for comment as of posting time. —Marlly Rome Bondoc/KG, GMA News

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