Sanofi on FDA’s cease and desist order: We have filed our response

Sanofi Pasteur, the dengue vaccine manufacturer, said Tuesday it has already responded to the order of the Food and Drug Administration (FDA) for an appropriate disease information and awareness campaign.

"In compliance with the FDA's order, we filed our answer on Dec. 27," Sanofi said in a statement.

Because the case is pending before the FDA, they declined to discuss further the merits of the case or to issue any other public statement.

"Suffice it to say that the cease and desist order is not related to the vaccine's safety and efficacy and is limited to the issues of complying with the FDA's regulations on product promotion," Sanofi briefly said in a statement.

The clarification was made after the FDA announced that it issued a summons with a cease and desist order against the pharmaceutical giant for airing television and radio advertisements of its dengue vaccine, Dengvaxia.

The FDA said the airing of the advertisement violates Administrative Order No. 65 s. 1989, prohibiting advertisement in any form of prescription or ethical drugs.

Through the summons, Sanofi was directed to cease and desist from disseminating advertisements for Dengvaxia in any form of mass or social media. It was also directed to stop activities promoting and marketing the vaccine.

Meanwhile, Sanofi said it is looking forward to participating in a preliminary conference with the FDA on the matter.

They also added that they will take this opportunity to further discuss how they can continue working closely with the government in conducting awareness campaigns for the benefit of the public.

Source: Philippines News Agency