FDA fines Sanofi P100k, suspends Dengvaxia registration certificate

The Food and Drug Administration (FDA) has imposed administrative sanctions on French drugmaker Sanofi Pasteur, ordering the certificate of product registration of dengue vaccine Dengvaxia suspended and an emblematic fine of P100,000.
 
The sanctions covered administrative lapses on the part of the Sanofi, like skirting the regulatory requirement of post-marketing surveillance reports.

Health Undersecretary Rolando Enrique Domingo told reporters Friday that the FDA released its decision on Dec.  29, 2017, or several months after the FDA Product Research Unit filed a complaint against Sanofi for not submitting the required documentary updates on Dengvaxia it was released.

Sanofi Pasteur has been in hot water after stating that Dengvaxia entails health risks, and that patients who have not been sick of dengue before taking the vaccine may experience a severe case of the disease.

The Food and Drug Administration (FDA) has ordered a one-year suspension of the certificate of product registration of controversial dengue vaccine Dengvaxia over its manufacturer’s alleged non-compliance with required post-marketing surveillance reports.

The administrative sanction comes with a fine of P100,000 for French pharmaceutical giant Sanofi Pasteur, which has been in hot water in the Philippines after announcing that its dengue vaccine may pose a risk of severe dengue to patients who have not had the infection prior to immunization.

An earlier advisory by the FDA suspended the sale, distribution, and marketing of Dengvaxia as a result of Sanofi Pasteur’s previous statement that the vaccine, the world’s first, poses potential harm in some cases.

Domingo noted the FDA actually asked Sanofi to submit post-marketing surveillance reports in December 2016, but the drugmaker did not receive a copy of the request until February of 2017, prompting the Product Research to lodge a complaint with the FDA—the relevant regulatory agency under the Department of Health. 

But Domingo emphasized the real problem plaguing Sanofi now has got nothing to do with relabeling the Dengvaxia information leaflets after the drugmaker announced in November 2017 the health risks related to the vaccine.

“It’s purely lack of submission of reports,” he said, noting company was required to submit regular updates on product monitoring.

Domingo said the “back-and-forth replies,” which took several months from February to December 2017 between the FDA and Sanofi, may explain why the sanctions were imposed only after Sanofi issued the statement that spurred public outcry and piqued congressional curiosity about how Dengvaxia entered the Health department’s multibillion-peso, anti-dengue vaccination program.

Sanofi Pasteur claimed that it practices company standards and submits periodic reports to regulatory authorities.

“As part of our standard company practices, Sanofi routinely conducts post-approval commitments to continuously evaluate the safety and effectiveness of our vaccines in the countries where they are in use, and we have done so in the Philippines with Dengvaxia,” the company said in a separate statement.  — VDS, GMA News