CA junks Sanofi appeal over Dengvaxia case

 

MANILA, Philippines – The Court of Appeals (CA) has denied the plea of pharmaceutical company Sanofi Pasteur Inc. (SPI) to rule on the merit of its petition that challenged the government’s revocation of its certificates of product registration (CPRs) for the controversial Dengvaxia vaccine.

Dengvaxia was tagged as responsible for the death of several children who were inoculated by the vaccine during the government’s anti-dengue drive.

In a 19-page decision, the CA’s 7th Division, SPI’s petition for review is already moot and academic since its CPRs have already expired on Dec. 22, 2020.

“All told, it is our view that the expiration of the marketing authorization on December 22, 2020, has rendered this case moot and academic. It is thus futile to insist on the reinstatement of the CPRs whose validity period had long expired,” the CA said through Associate Justice Eduardo Ramos Jr.

On Dec. 29, 2015, the Food and Drug Administration (FDA) suspended for one year the CPRs of SPI. SPI was also ordered to pay a P100,000 fine for its failure to submit post-approval commitment documents.

Then, on Dec. 21, 2018, the FDA permanently revoked CPRs for Dengvaxia.

SPI filed a motion to reconsider the FDA’s decision, saying that the order violated its right to due process for lack of notice or warning that there was an administrative proceeding against it.

The FDA, however, denied the motion for reconsideration, prompting SPI to file an appeal before the Department of Health (DOH).

Still, the DOH stood by the findings of the FDA, stating that SPI was afforded sufficient notice and the opportunity to be heard and that it violated the rules on post-approval or post-authorization requirements and/or commitments.

SPI then took its case to the Office of the President, which ruled against them.

SPI elevated the case to the CA.

In dismissing the petition for review, the CA said: “This Court finds that the issue at hand is not the efficacy of Dengvaxia. Rather, the crux of this controversy centers on the compliance or non-compliance of the post-marketing authorization requirements by SPI.”

SPI argued that reinstatement of the CPRs for Dengvaxia is in the interest of the health and safety of the Filipino people, as this would help mitigate the dengue epidemic.

But the CA said SPI’s argument “no longer holds water because reinstatement of the CPRs is no longer possible. The CPRs expired more than a year ago, and SPI has no pending application for a new CPR.”

The administration of then president Benigno Aquino III spent P3.5 billion to procure the Dengvaxia vaccine manufactured by SPI, which was registered with the FDA in 2015.

 The vaccine was administered to children in Central Luzon, Southern Tagalog, and Metro Manila by April of the same year.

In 2018, the DOH stopped the mass immunization after SPI announced the results of a new analysis showing Dengvaxia worsened symptoms in vaccinated people with no previous exposure to dengue.