- Sanofi's mission to roll out its Dengue fever vaccine in areas hit particularly hard by the disease suffered a setback on Tuesday, after the Philippine Food and Drug Administration requested the French pharma pull ads for the drug.
- It has been illegal in the country to advertise doctor-prescribed pharmaceuticals since 1989. As such, the agency said in a Jan. 2 statement it had called for the company's vaccine arm, Sanofi Pasteur, to take down television and radio ads for Dengvaxia in mid-December, but the call had gone unanswered. That resulted in the PFDA issuing a cease and desist order (CDO).
- "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," Philippines FDA Director Nela Charade G. Puno said in the statement.
Puno also revealed her agency sent letters to broadcasting stations asking them not to run the ads, though she did not divulge specific names. The Philippines FDA approved Dengvaxia in December 2015, and in April the country's Department of Health began a program aimed at immunizing 1 million school children with the vaccine.
"This apparent reversal of the FDA’s previous approval of the material and content for this disease prevention awareness campaign comes as a complete surprise to the company which was in continuous contact with the FDA to ensure compliance of this campaign before its launch in the Philippines on Nov. 4," said Sanofi Pasteur in an emailed statement.
"According to the terms of the CDO from the FDA on this matter, we filed our answer on Dec. 27 and took action to stop all campaign-related activities as directed by the Agency," the company said. "Sanofi has also requested a meeting with the FDA to review the legal basis for this apparent decision reversal by the Agency."
Sanofi is not releasing any official statement on the matter since the case against it is still pending.
Sanofi spent more than 20 years cooking up Dengvaxia. In August, an advisory group to the World Health Organization (WHO) recommended the vaccine in countries with high Dengue transmission. According to WHO-cited reports, around 390 million people are infected with the disease every year and ten times that are at risk of catching it.
"[The advisory group's recommendations] further validate the scientific and medical value of Dengvaxia and send a clear message to endemic countries about the strong public health benefit to be gained by introducing the dengue vaccine in integrated disease management efforts to combat their dengue burden," Sanofi's President of Global R&D Elias Zerhouni said in an April statement.
Dengvaxia helped increase Sanofi vaccine sales in emerging markets since it was first approved in December 2015 in Mexico. The company's most recent quarterly financial report showed the drug brought in €50 million ($52 million) during the first nine months of 2016. By the end of September, 13 countries in total – all located in either South America are Southeast Asia – had given the vaccine the green light.