In a statement, Health Secretary Francisco Duque said “the decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety.”
DOH said that Sanofi has failed to submit the third version of the Risk Management Plans , and has belatedly submitted the fourth version, in violation of its post-marketing commitments and pertinent FDA rules and regulations. “The DOH is committed to strong and strict implementation of our health laws and regulations. We know how critical this is to our efforts to rebuild public trust and confidence in our public health programs and in vaccines that have long been proven effective,” Duque said.
“We assure the public that the DOH has been working tirelessly in response to the nationwide dengue epidemic. We are intensifying the 4s strategy and ensuring that our health facilities are adequately equipped to serve its patients,” he added.
Good decision Dengvaxia very new Experimental Best to be prudent If ever, should come with warning that user assumes risk RT : DOH stays permanent revocation of Dengvaxia CPR, cites Sanofi’s disregard of regulations
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