FDA Issues Cease and Desist Order vs Sanofi; Philippine Gov’t Dengue Vaccine Procurement Under Investigation

After Sanofi Pasteur, Inc. failed to comply with the directives of the Philippine Food and Drug Administration (FDA) to take down its advertisement for dengue vaccine, the government agency immediately issued a summon with cease and desist order against the French pharmaceutical giant.

Sanofi reportedly violated Administrative Order no. 65 s. 1989 which prohibits the advertisement of any form of prescription or ethical drugs since these can only be dispensed with a doctor’s order. In addition to the company’s unauthorized promotion of dengue vaccine known as Dengvaxia in the malls, the FDA’s Center for Drug Regulation and Research (CDRR) has also monitored the radio and television ads of the product.

FDA then directed the company to stop promotion and marketing activities involving the dengue vaccine. Sanofi, however, has failed to comply with the order.

“Since Sanofi have 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,” said FDA Director General Nela Charade G. Puno, as per the report of Manila Bulletin.

On the other hand, Sanofi offered in a statement that it has already responded to the order and since the case is pending, it kept mum on the merits of the case. The company, however, clarified that the cease and desist order is not related to the vaccine’s safety and efficacy.

Dengvaxia marked as the first dengue prevention vaccine to be licensed in Asia. It is a tetravalent dengue vaccine that can prevent diseases caused by all four dengue types in individuals.

Despite receiving a recommendation from the World’s Health Organization, the Philippine Senate Blue Ribbon Committee chaired by Sen. Richard Gordon is currently investigating the alleged rush procurement in the Department of Health of the P3.5 million worth Dengvaxia. Gordon was baffled by the procedural lapses of the procurement process.

The issue was further heightened following the deaths of two children who received the first dose of the vaccine in April 2016. As reported by Manila Standard, the Blue Ribbon just finished conducting its first hearing last December 6.

FDA is then urging everyone’s cooperation to ensure that the public is provided with correct information on the food, drugs, and any health devices that they use. Stay tuned for more exciting updates!