2 FDA officials relieved of posts over Dengvaxia

2017-12-04 (2)

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2 FDA officials relieved of posts over Dengvaxia


MANILA (Philippines News Agency)  — The Department of Health (DOH) on Wednesday ordered the relief and re-assignment of two officials of the Food and Drug Administration (FDA) linked to the issuance of the Certificate of Product Registration (CPR) to Sanofi Pasteur for its dengue vaccine, Dengvaxia.

In a Department Personnel Order, Health Secretary Francisco Duque III ordered the immediate revocation of the assignment of Ma. Lourdes C. Santiago as Acting Deputy Director-General for Field Regulatory Operations Office, and the temporary relief of Dr. Benjamin G. Co as Director IV of the Center for Drug Regulation and Research, pending the DOH investigation on Dengvaxia.

The two were reassigned to the Office of the FDA Director-General.

In the order, Duque said Santiago “had material participation in the approval of the market authorization application of Sanofi Pasteur Inc. for Dengvaxia”.

Co, meanwhile, was temporarily relieved due to “his express admission that he received an advance copy of a certain document or documents in a USB in violation of FDA Circular 2017-015”. No further explanation was provided.

“These precautionary measures are being undertaken in the interest of transparency and to ensure the integrity of the audit being done by the department in conjunction with the FDA,” read the order.

On Dec. 22, 2015, the FDA gave Sanofi Pasteur a CPR. After the CPR registration, the DOH under former secretary Janette L. Garin announced that the government was going to implement a dengue vaccination program.

The CPR for Dengvaxia was suspended last December after Sanofi Pasteur’s disclosure that severe dengue could occur among recipients of the vaccine who have not had prior infection. As a result, the sale of the product was suspended, while the company was fined PHP100,000 for failing to comply with post-marketing authorization requirements.

The use of Dengvaxia in the immunization program was also suspended as DOH stood to cooperate with the investigation and in reaction to public uproar.

Since then, congressional hearings had been conducted to dig deeper into any alleged irregularity in the procurement and implementation of the dengue vaccination program. (PNA)



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