Sanofi commits to comply with PH laws
Published Jan 5, 2018 04:26 pm
By Charina Clarisse Echaluce
The French company Sanofi Pasteur has committed to comply with the Philippine laws and to cooperate with the Food and Drug Administration (FDA).
Sanofi said that on December 29, 2017, Food and Drug Administration notified Sanofi Pasteur of a one-year suspension of Dengvaxia marketing authorization.
Suspended
Earlier, the FDA slapped the pharmaceutical firm with an administrative fine of P100,000 over its failure to comply with existing regulatory requirements; and suspended for a period of one year the Certificates of Product Registration (CPR) of Dengvaxia and Dengvaxia MD.
A worker shows used anti-dengue vaccine Dengvaxia inside a vaccine storage room in Sta. Cruz city, December 4, 2017. (REUTERS/Romeo Ranoco/File Photo | Manila Bulletin)
Sanofi said in a statement that this suspension was linked to a failure to comply with post-marketing requirements but that it was “not linked to the product profile.”
Sanofi said: “As part of our standard company practices, Sanofi routinely conducts post-approval commitments to continuously evaluate the safety and effectiveness of our vaccines in the countries where they are in use, and we have done so in the Philippines with Dengvaxia.
Sanofi Pasteur said it “confirms that in accordance with international and local laws, regulations and company standards, post-approval commitments for Dengvaxia, as described in the pharmacovigilance plan submitted to the Philippines FDA and other national regulatory authorities, have been – and will continue to be – fulfilled.
Sanofi Pasteur said it will “continue to cooperate in full transparency with the Philippines FDA and is committed to comply with the Philippines laws and regulations.”
On November 29, 2017, the Sanofi Pasteur announced a "new finding" on its vaccine Dengvaxia, which was used in the government's mass immunization program involving around 830,000 children.
The company added:"The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection... For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection."
On December 1, 2017, Health Secretary FranciscoDuque put on hold the government vaccination drive.
The Sanofi, on the other hand, noted: “The global risk management and pharmacovigilance plan for Dengvaxia is the same for all countries where the product has been approved, and periodic reports are submitted to the national regulatory authorities where Dengvaxia is approved. No other requests of market withdrawal or license suspension have been received from other NRAs where the vaccine is approved.”
The FDA said: "Wherefore, premises considered and finding substantial evidence that Sanofi Pasteur violated Section V of FDA Circular 2013-004, the Certificate of Product Registration of Dengvaxia MD and Dengvaxia are suspended for a period of one year upon service of the decision." The FDA six-page decision was dated December 29.
The FDA explained that the suspension means there shall be no Sanofi Pasteur applications in relation to the products until the suspension period has lapsed.
The FDA noted that the decision to rule against Sanofi came after it was determined that Sanofi failed to submit on time the required post-approval commitment documents relative to the dengue vaccine.
With this, the firm was warned that repeated violation of FDA rules shall result in stiffer penalties such as cancellation of concerned CPRs or the License to Operate, which could lead to closure of the establishment.
Moreover, the FDA questioned the actions of Sanofi to submit the documents in accordance to their own planned submission dates.
"Unfortunately for the respondent, the timely submission of these reports is mandatory and may not be unilaterally changed upon the market authorization holder's request," said the FDA.
"Such timely submission is important considering that this is a new drug under a conditioned/monitored release," the FDA added.
The agency also took notice of the firm’s lack of sincerity to comply with the post-marketing authorization issuance commitments.
"Records and evidence clearly show that respondent failed to comply with its post-marketing authorization issuance commitments and that it has exhibited the propensity to not comply with this Office's regulatory requirements for its products," said the FDA.
A worker shows used anti-dengue vaccine Dengvaxia inside a vaccine storage room in Sta. Cruz city, December 4, 2017. (REUTERS/Romeo Ranoco/File Photo | Manila Bulletin)
Sanofi said in a statement that this suspension was linked to a failure to comply with post-marketing requirements but that it was “not linked to the product profile.”
Sanofi said: “As part of our standard company practices, Sanofi routinely conducts post-approval commitments to continuously evaluate the safety and effectiveness of our vaccines in the countries where they are in use, and we have done so in the Philippines with Dengvaxia.
Sanofi Pasteur said it “confirms that in accordance with international and local laws, regulations and company standards, post-approval commitments for Dengvaxia, as described in the pharmacovigilance plan submitted to the Philippines FDA and other national regulatory authorities, have been – and will continue to be – fulfilled.
Sanofi Pasteur said it will “continue to cooperate in full transparency with the Philippines FDA and is committed to comply with the Philippines laws and regulations.”
On November 29, 2017, the Sanofi Pasteur announced a "new finding" on its vaccine Dengvaxia, which was used in the government's mass immunization program involving around 830,000 children.
The company added:"The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection... For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection."
On December 1, 2017, Health Secretary FranciscoDuque put on hold the government vaccination drive.
The Sanofi, on the other hand, noted: “The global risk management and pharmacovigilance plan for Dengvaxia is the same for all countries where the product has been approved, and periodic reports are submitted to the national regulatory authorities where Dengvaxia is approved. No other requests of market withdrawal or license suspension have been received from other NRAs where the vaccine is approved.”
The FDA said: "Wherefore, premises considered and finding substantial evidence that Sanofi Pasteur violated Section V of FDA Circular 2013-004, the Certificate of Product Registration of Dengvaxia MD and Dengvaxia are suspended for a period of one year upon service of the decision." The FDA six-page decision was dated December 29.
The FDA explained that the suspension means there shall be no Sanofi Pasteur applications in relation to the products until the suspension period has lapsed.
The FDA noted that the decision to rule against Sanofi came after it was determined that Sanofi failed to submit on time the required post-approval commitment documents relative to the dengue vaccine.
With this, the firm was warned that repeated violation of FDA rules shall result in stiffer penalties such as cancellation of concerned CPRs or the License to Operate, which could lead to closure of the establishment.
Moreover, the FDA questioned the actions of Sanofi to submit the documents in accordance to their own planned submission dates.
"Unfortunately for the respondent, the timely submission of these reports is mandatory and may not be unilaterally changed upon the market authorization holder's request," said the FDA.
"Such timely submission is important considering that this is a new drug under a conditioned/monitored release," the FDA added.
The agency also took notice of the firm’s lack of sincerity to comply with the post-marketing authorization issuance commitments.
"Records and evidence clearly show that respondent failed to comply with its post-marketing authorization issuance commitments and that it has exhibited the propensity to not comply with this Office's regulatory requirements for its products," said the FDA.