Two officials said to have role in giving certificate of product registration on dengue vaccine relieved

February 21, 2018

Two officials of the Food and Drug Administration (FDA) have been relieved and reassigned due to their alleged links with issuing a Certificate of Product Registration (CPR) to Sanofi Pasteur, Inc. for its dengue vaccine.

In a department order, Health Secretary Francisco Duque III ordered the immediate revocation of the appointment of Ma. Lourdes Santiago as acting deputy director-general for Field Regulatory Operations Office, and of Benjamin Co as Director IV of the Center for Drug Regulation and Research.

“The precautionary measures are being undertaken in the interest of transparency and to ensure the integrity of the audit being done by the DOH ( Department of Health) in conjunction with the FDA,” said Duque.

Duque said Santiago “had material participation in the approval of the market authorization application of SPI for Dengvaxia”.

Co was relieved “pending the DOH investigation on Dengvaxia, following his express admission that he received an advance copy of document or documents in a USB”, which is in violation of an FDA circular.

In December 22, 2015 when the FDA gave Sanofi Pasteur a certificate of product registration

The certificate for Dengvaxia has since been suspended for a year, with the company fined P100,000 for failing to comply with post-marketing authorization requirements.

Duque named Emilio Polig Jr. to replace Santiago, while Katherine Austria-Lock was tapped to replace Co. Santiago and Co have been reassigned under the Office of the FDA director general.  DMS