FDA slaps Sanofi with P100,000 fine

Image from Fierce Pharma
  • The FDA slapped Sanofi Pasteur with a P100,000 fine
  • The FDA said Sanofi failed to comply with the agency’s regulatory requirements
  • Sanofi Pasteur is the manufacturer of the controversial anti-dengue vaccine Dengvaxia

The Food and Drug Administration (FDA) penalized Sanofi Pastuer, the manufacturer of the world’s first anti-dengue vaccine Dengvaxia, with a P100,000 fine.

The FDA, as per ABS-CBN, have also cancelled the product registration of Dengvaxia for a year for failing to comply with the agency’s regulatory requirements.

“Records and evidence clearly showed that respondent failed to comply with its post-marketing authorization issuance commitments, and that it has exhibited the propensity to not comply with this office’s regulatory requirements for its products, Dengvaxia and Dengvaxia MD,” the FDA said in its decision dated December 29, 2017.

On December 5, 2015, the FDA suspended the sale, distribution and marketing of Dengvaxia in the country after Sanofi Pasteur disclosed that the anti-dengue vaccine has possible harmful effects on children who have been inoculated with the vaccine but who have no prior dengue infection.