FOR Failing to comply with post-marketing authorization requirements for the vaccine, French pharmaceutical giant Sanofi Pasteur was fined with P100,000 (around $2,000 at current exchange rates) by the Philippines’s Food and Drug Administration (FDA) and was not allowed to sell the controversial Dengvaxia dengue vaccine for a year.
“Records and evidence clearly showed that respondent failed to comply with its postmarketing 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 a decision dated December 29, 2017, and signed by Director General Nel Charade Puno.
The amount is peanuts compared to the €1.916 billion (about $2.31 billion) that Sanofi Pasteur posted as worldwide sales in the third quarter of the year, the firm’s financial statement for the period revealed.
Under the FDA’s postmarketing surveillance stage, a company is required to submit several documents to ensure the product is still safe to use even after its release in the market.
Sanofi failed to comply after the FDA had issued its certificate of product registration on December 22, 2015, the FDA said.
The government spent P3.5 billion (around $70.245 million) for the vaccine for the immunization program in 2016, under which some 830,000 children have benefited.
