THE Court of Appeals has turned down the plea of pharmaceutical company Sanofi Pasteur Inc. (SPI) to rule on the merit of its petition assailing the government’s decision to revoke its certificates of product registration (CPR) for the controversial Dengvaxia, a vaccine used for protection against dengue disease.
In a 19-page decision penned by Associate Justice Eduardo Ramos Jr., the CA declared that SPI’s petition for review is already moot and academic, considering that its CPRs have already expired on December 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 ruled.
It can be recalled on December 29, 2017, the Food and Drug Administration (FDA) issued an order suspending SPI’s CPRs for one year and imposed a fine of P100,000 due to its failure to submit post approval commitment documents.
On December 21, 2018, the FDA issued another order permanently revoking the CPRs of Dengvaxia.
SPI filed a motion for reconsideration and argued that the issuance of the assailed order violated its right to due process for lack of notice or warning that there was an administrative proceeding against it.
It insisted it had complied with the post-marketing authorization requirements.
In a resolution dated February 15, 2019, the FDA denied the motion for reconsideration and affirmed its earlier order, prompting SPI to file an appeal before the Office of the Secretary of the Department of Health (DOH).
However, in a decision dated August 19, 2019, the DOH affirmed the FDA’s order revoking the CPRs.
The Secretary of Health ruled 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.
The petitioner elevated the case to the Office of the President (OP), which affirmed the DOH’s ruling that there was no denial of due process against SPI.
The OP also noted that some of the post-approval commitments of SPI were delayed or not complied with.
The SPI elevated the case before the CA where it maintained that the revocation of its CPRs was done in violation of its right to due process. -30-