Philippine FDA orders Sanofi to pull dengue vaccine ads
pharmafile | January 5, 2017 | News story | Medical Communications, Sales and Marketing | Philippines, Sanofi, Vaccine, dengue, virus
Sanofi has suffered a major blow to its dengue immunisation programme in the Philippines after it was requested the company and its vaccine arm Sanofi Pasteur pull all advertisements for its preventative treatment Dengvaxia in the country.
Under legislation active since 1989 on the authority of the Philippine Food and Drug Administration, it is illegal to advertise any ethical or prescription pharmaceuticals in the region.
The government issued the order on December 13; the administration also reached out to broadcasters in an effort to pull the advertisements. According to the FDA, Sanofi did not respond until at least December 15:
“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 penalised for violating the law,” stated Philippines FDA director Nela Charade G. Puno.
Sanofi has since said it has taken down the advertisements in question, noting in a statement that the FDA’s backpedalling came as a “complete surprise” to the company:
“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 November 4. According to the terms of the CDO (Cease and Desist Order) from the FDA on this matter, we filed our answer on December 27 and took action to stop all campaign-related activities as directed by the Agency. Sanofi has also requested a meeting with the FDA to review the legal basis for this apparent decision reversal by the Agency.”
The company first announced the programme, the first public immunisation effort in the country, in April 2015; the Philippine FDA approved Dengvaxia in December later that year, after 20 years and $1.5 billion of development on Sanofi’s part.
Sanofi noted that its immunisation programme is designed to target those areas hit hardest by the dengue virus; Asia currently accounts for 70% of all global cases.
Matt Fellows
Related Content
BioNet receives positive EMA opinion on new pertussis vaccine
BioNet has received a positive opinion from the Committee for Medicinal Products for Human Use …
Recipharm offers manufacturing support to vaccine trial from ImmBIO and iiCON
Recipharm, a contract development and manufacturing organisation (CDMO), has successfully manufactured PnuBioVax, a new protein-based …
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
