The Court of Appeals denied the petition of pharmaceutical company Sanofi Pasteur, Inc. (SPI), assailing the government’s decision to revoke its certificates of product registration (CPR) for the controversial Dengvaxia, a vaccine used for protection against dengue.
Associate Justice Eduardo Ramos, Jr. of the seventh division wrote a 19-page decision, declaring that the SPI petition for review had been rendered moot and academic, considering that its CPRs 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 held.
The Food and Drug Administration (FDA) suspended the CPRs of SPI for a year last Dec. 29, 2017. It also Imposed a fine of P100,000 on the company due to its failure to submit post approval commitment documents. FDA permanently revoked the CPRs for Dengvaxia on Dec. 21, 2018.
SPI filed a motion for reconsideration, arguing that the order violated its right to due process because it was not notified of an administrative case. The firm insisted it had complied with post-marketing authorization requirements for the vaccine.
In a resolution dated Feb. 15, 2019, the FDA denied the motion and affirmed its earlier order, prompting SPI to file an appeal before the Office of the Secretary of the Department of Health (DOH). But in a decision dated Aug. 19, 2019, the DOH affirmed the FDA revocation order.
The Secretary of Health ruled that SPI was afforded sufficient notice and the opportunity to be heard. The company then elevated the case to the Office of the President, which affirmed the DOH ruling that there was no denial of due process against SPI.
The Dengvaxia manufacturer asserted that it complied with post-marketing authorization requirements, adding that even if there had been lapses in the process, this was not enough to warrant an immediate revocation of the CPR.
In denying SPI petition, CA agreed with the position of the Office of the Solicitor General (OSG), which represented DOH and FDA, that the reinstatement of CPRs was no longer possible because it already expired in 2020.
“To be clear, however, 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,” the CA noted.
“Simply, the expiration of the marketing authorization on December 22, 2020 operates as a supervening event that mooted this petition,” it added.
The DOH purchased Dengvaxia for P3.5-billion, which was registered with the FDA in 2015 during the administration of then President Benigno Aquino III. The vaccine was subsequently administered to children in Central Luzon, Southern Tagalog, and Metro Manila by April the same year.
It became controversial when SPI issued an advisory saying a new clinical analysis found the vaccine effective for people who had dengue prior to immunization, but those who had not been infected of the disease were at risk of developing “severe” diagnosis.
Several criminal cases were filed against former and current public health officials in connection with the deaths of several children, who allegedly suffered complications after being administered with the Dengvaxia.