Ex-FDA drug regulation chief gave Sanofi special 'accommodation' for Dengvaxia
MANILA, Philippines (2nd UPDATE) – The current Food and Drug Administration (FDA) chief said their former director for drug regulation and research gave special “accommodation” to Dengvaxia maker Sanofi Pasteur.
On Monday, February 26, FDA director-general Nela Charade Puno told lawmakers that ex-Center for Drug Regulation and Research (CDRR) director Benjamin Co received a USB drive directly from Sanofi.
FDA rules prohibit companies from directly providing materials to the agency’s evaluators. Instead, FDA has separate action centers where the companies should submit their documents.
The USB contained Sanofi's response to Co who, in April 2017, pointed out multiple violations of the French pharmaceutical giant with FDA's rules on post-marketing authorization.
Co's April 2017 report was the basis of FDA's one-year suspension and P100,000 fine on Sanofi.
Puno said Co’s direct line to Sanofi was discovered by FDA’s Dengvaxia Task Force, formed after the Department of Health (DOH) suspended the school-based dengue immunization program. Sanofi revealed the vaccine is risky for people who had not been infected by dengue yet.
“I presumed that Dr Benjie Co was doing his job in closely monitoring the submission of the post marketing reports [of Sanofi]. What happened was we had to investigate and we found out several issues wherein there’s doubt in terms of submissions or entertaining or accommodating Sanofi,” said Puno as the House resumed its probe into the Dengvaxia controversy.
She said the task force discovered “accommodation [was] being given [by Co] to Sanofi and [allowed] the non-compliance to standard requirements.” This includes the prohibition against direct communications between companies and FDA evaluators.
House good government and public accountability panel chairperson Johnny Pimentel then asked Puno if she is insinuating Co gave “special treatment” to Sanofi. She agreed.
“Yes sir, looking at all the circumstances, that’s the conclusion,” said Puno.
Co was not invited to the House hearing and therefore could not defend himself before legislators.
But his lawyer Joseph Estrada explained to Rappler that Sanofi gave the USB to Co because DOH Francisco Duque III wanted an advance copy of the company's presentation regarding the re-labelling application of Dengvaxia.
"No'ong pumunta doon 'yong taga-Sanofi to hand in the USB that day, it violated a circular says that says na bawal directly mag-transact ang FDA," said Estrada.
Duque last week already removed Co from his post as CDRR director and reassigned him under Puno’s office while both the FDA and DOH probe the Dengvaxia mess. Co is set to file his formal appeal.
In a separate statement, Estrada said Co's relief was due to his alleged failure to submit the advance copies.
"Such failure, however, at most, presents procedural lapses on the part of Dr Co for violating FDA Memorandum 2017-015 in accepting the advanced copies of the re-labeling application to his staff," said Estrada.
He added this has not prejudiced the FDA's ongoing reviewing of Sanofi's application for re-labeling at the time.
"When this happened, the Dengvaxia had already bee suspended from the market and Sanofi had been ordered to submit a full dossier of its recommendations. The copies with Dr Co were advanced copies," said Estrada.
Acting deputy director general for FDA’s Field Regulatory Operations Office Maria Lourdes Santiago has also been reassigned under Puno’s office.
She was the FDA officer-in-charge when the agency allowed Sanofi to sell Dengvaxia in the Philippines in December 22, 2015.
During the same hearing, Puno and physician Anthony Leachon said documents prove Sanofi knew about the risks of its vaccine as early as December 22, 2015, but did not disclose this to the Philippine government. – Rappler.com
Editor's Note: An earlier version of this article said the USB given to Co was in relation to Sanofi's application for a certificate of product registration for Dengvaxia. This has been corrected to refer to the proper document.