2 FDA execs relieved over Dengvaxia mess

Health Secretary Francisco Duque III has relieved two officials of the Food and Drug Administration (FDA) in connection with the licensing of anti-dengue vaccine Dengvaxia.

In a two-page directive last Tuesday, Duque ordered the revocation of the appointment of Ma. Lourdes Santiago as acting deputy director-general for FDA’s field regulatory operations.

Duque also removed Benjamin Co from his post as director of the Center for Drug Regulation and Research.

Both Santiago and Co were re-assigned to the office of the FDA director-general pending the investigation of the Department of Health (DOH) on the Dengvaxia controversy.

But the relief was made “without reduction in ranks and/or salaries, including benefits, representation and transportation allowance and other privileges” due to the two officials.

Lawyer Emilio Polig Jr. was named Santiago’s replacement while lawyer Katherine Lock took over Co’s post.

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

The audit is in connection with the Certificate of Product Registration (CPR) issued to Sanofi Pasteur Inc. (SPI) for the Dengvaxia vaccine.

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

Duque added that Co was transferred “in view of his express admission that he received an advance copy of a certain document” in a flash drive, which is a violation of FDA Circular 2017-015.

He was referring to Co’s admission during a Senate hearing that he received a flash drive delivered by Sanofi, violating the FDA’s rule against dealing directly with pharmaceutical firms and other external parties.

FDA issued the CPR to Sanofi on Dec. 22, 2015. Last month, FDA suspended Sanofi’s CPR for one year and imposed a fine of P100,000 as the company had failed to comply with post-marketing authorization requirements.

Meanwhile, Congress will likely support the passage of a supplemental budget to fund the compensation and reimbursement of expenses of children injected with Dengvaxia who later succumbed to complications, some deadly.

The possibility of passing a supplemental budget was raised during the Senate inquiry into the Dengvaxia controversy yesterday as officials of the DOH and the Public Attorney’s Office (PAO) testified that deaths believed to have been caused by the vaccine have reached 40 since the P3.5-billion immunization program for dengue was halted in October last year.

Duque said he is drafting a letter to President Duterte as well as to the leaders of the Senate and the House of Representatives to authorize the supplemental budget.

Duque said the supplemen- tal budget is to be funded by the P1.16 billion refunded by Sanofi last January to the government for the unused doses. While the money refunded by Sanofi is now with the DOH, using it for such a purpose needs congressional approval.

Duque agreed with Sen. Richard Gordon, chairman of the Blue Ribbon committee, that the supplemental budget should be without prejudice to whatever claims the government will pursue against Sanofi.

Sanofi’s refund represented the unused doses but Senate President Aquilino Pimentel III and Duque had earlier separately asked Sanofi to refund the government in full.

The probe is jointly conducted with the Senate committee on health, chaired by Sen. Joseph Victor Ejercito.

Duque, however, stressed that the Philippine Health Insurance Corp. (PhilHealth) is ready to extend financial aid to parents whose Dengvaxia-inoculated children succumbed to complications, particularly dengue, at P10,000 at the minimum per case.

During the hearing, parents of children who died or got ill supposedly due to Dengvaxia pleaded with Duque to help defray their medical expenses.

Duque reported that some 1,170 “adverse events” have been recorded from those inoculated since the vaccination program stopped in the fourth quarter last year, with 37 deaths. PAO chief Persida Acosta said the figure has risen to 40 with three new deaths in Luzon.