Sanofi plea for Dengvaxia denied

The FDA was asked by Sanofi to reconsider the revocation, claiming it was denied due process for lack of notice

The petition filed by Sanofi Pasteur Inc. challenging the government decision revoking its certificates of product registration for Dengvaxia vaccine was denied by the Court of Appeals.

In a decision written by Associate Justice Eduardo S. Ramos Jr., the CA said: “All told, it is our view that the expiration of the marketing authorization on 22 Dec. 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.”

On 29 December 2017, the Food and Drug Administration suspended Sanofi’s CPRs for one year with a fine of P100,000 for failure to submit post-approval commitment documents. On 21 December 2018, FDA revoked Sanofi’s CPRs.

The FDA was asked by Sanofi to reconsider the revocation, claiming it was denied due process for lack of notice.

Also, Sanofi said that it had complied with the post-marketing authorization requirements.

When its motion for reconsideration was denied by the FDA, it filed an appeal before the Office of the Secretary of the Department of Health which likewise denied the appeal on 19 August 2019.

An appeal was filed by Sanofi to the Office of the President which also denied its plea.

It opted to file a petition before the CA, telling the court that even if it complies with its post-marketing authorization requirements, there is no basis for the immediate revocation of the CPRs.

The CA, agreeing with the Office of the Solicitor General which represented the FDA and the DoH — ruled that the reinstatement of the pharmaceutical firm’s CPRs would no longer be possible as it had already expired on 22 December 2020.