(Eagle News) — The Food and Drug Administration has imposed a P100,000 fine on French drug manufacturer Sanofi Pasteur for its alleged failure to comply with post-marketing authorization requirements.
The FDA also suspended the sale of the company’s controversial anti-dengue vaccine Dengvaxia for a year.
“Records and evidence clearly showed that respondent….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.
The decision was signed by Director General Nel Charade Puno.
In a statement, Sanofi Pasteur said it complied with post-approval requirements for the dengue vaccine.
“Sanofi Pasteur will continue to cooperate in full transparency with the Philippine FDA and is committed to comply with the Philippine laws and regulations,” the company said, even as it noted that there were no withdrawal orders in countries where the vaccine was sold.
The FDA earlier ordered the suspension of the sale, marketing and distribution of Dengvaxia, following Sanofi Pasteur’s admission the vaccine could cause “severe cases” in those who have not had dengue before.
In its defense, the company said the information came to light only recently.
The vaccine was procured during the term of former President Benigno Aquino III.
Over 800,000 schoolchildren were administered the vaccine under the government’s dengue immunization program.