CA rejects Dengvaxia maker’s last-ditch plea to review voiding of FDA license

The Court of Appeals (CA) has denied the motion for reconsideration filed by French drugmaker Sanofi Pasteur Inc. over the dismissal of its appeal to review the government’s revocation of the certificates of product registration (CPRs) for its controversial dengue vaccine, Dengvaxia.

In a resolution dated Sept. 20, the appellate court denied Sanofi’s motion to overturn the Jan. 31 decision, which dismissed its petition for review for being moot and academic.

“A motion for reconsideration grounded on arguments already submitted to this Court and found to be without merit may be denied summarily, as it would be a useless ritual for this Court to reiterate itself,” read part of the resolution penned by Associate Justice Eduardo Ramos Jr.

The case was based on a Food and Drug Administration (FDA) order dated Dec. 21, 2018, permanently revoking the CPRs for Dengvaxia after Sanofi failed to submit documentary evidence showing the vaccine was safe and effective for public use.

Expired CPRs

The FDA decision came more than a year after Sanofi announced in November 2017 that the vaccine could cause severe dengue in individuals without a history of contracting the mosquito-borne disease. This led to the discontinuation of the vaccination program initiated by the government in 2016 following a surge in cases.

In its ruling on the petition filed by Sanofi against the Department of Health (DOH) and the FDA, the appellate court said in January that the expiration of the marketing authorization granted to the pharmaceutical company in December 2020 rendered the case moot and academic.

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Wider impact

Sanofi then filed a motion for reconsideration on Feb. 28, arguing that the court should have addressed the issues raised in the petition despite the expiration of the CPRs and the absence of a new application.

Sanofi insisted that any ruling by the court on these issues would impact the marketing and commercialization of drugs and vaccines in the Philippines.

The DOH and FDA, represented by the Office of the Solicitor General, said in their comments that Sanofi was “only interested in vindicating itself” and the relief sought “do[es] not advance or advocate the public interest of the Filipino people.” INQ