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FDA files case against Sanofi

The Philippine Food and Drug Administration said it filed an administrative case against French pharmaceutical giant Sanofi Pasteur Inc. for violating Administrative Order No. 65 s. 1989 when it aired television and radio advertisements of its dengue vaccine, Dengvaxia.  

The administrative order prohibits the advertisement, in any form, of prescription or ethical drug. 

Sanofi was issued a summons with cease and desist order by the FDA in December for airing the subject advertisement. 

The FDA legal service will hear the case in accordance with the quasi-judicial powers of the FDA under Republic Act 9711 or the Food and Drug Administration Act of 2009. 

FDA director general Nela Charade Puno said that when FDA filed an administrative case against an entity like Sanofi, it had the power to suspend, revoke or cancel the license to operate of the company or the certificate of product registration of the product itself.  

“Even if they have stopped airing their advertisements, they can still face administrative sanctions for violating the law in the first place.” Puno said. 

Topics: Philippine Food and Drug Administration , FDA , Sanofi Pasteur Inc. , dengue vaccine , Dengvaxia
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