FDA Issues Cease and Desist Order vs Sanofi

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The Philippine Food and Drug Administration (FDA) has issued a Summons with Cease and Desist Order against pharmaceutical giant Sanofi Pasteur Inc. for airing television and radio advertisements of its dengue vaccine, Dengvaxia. The airing of the advertisement is in violation of Administrative Order No. 65 s. 1989, prohibiting advertisement in any form of prescription or ethical drug.

The FDA's Center for Drug Regulation and Research (CDRR) has monitored the airing of the advertising materials on dengue vaccination. It has also reported the unauthorized promotion of dengue vaccine in the malls.

In the Summons issued by FDA last December 13, 2016, Sanofi was directed to cease and desist from disseminating advertisements for Dengvaxia in any form of mass or social media. Sanofi was also directed to stop activities promoting and marketing the vaccine. However, as of December 15, 2016, the company has failed to comply with FDA’s directive to take down the said advertisements.

"Since Sanofi has not complied, we have issued summons directing them to cease and desist from airing the advertisements and Show Cause why they should not be penalized for violating the law." FDA Director General Nela Charade G. Puno said.

Puno added that to ensure immediate compliance, "the FDA already sent letters to TV and Radio Stations directing them not to air the said unauthorized ads."

Puno also said the FDA will monitor compliance by Sanofi and the stations.

"We are looking forward to their cooperation in our mandate to ensure that the public is provided only with the correct information on the food, drugs, cosmetics, and health devices that they use,” Puno pointed out.

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