Seeking to appease angry regulators, Novartis (NVS) committed to notifying the Food and Drug Administration within five business days of learning of any “credible allegation” in which manipulated data may affect a pending marketing application before the agency or regulators in other countries.
The company publicly disclosed the vow at an investor meeting on Monday, although the commitment was made to the FDA last month as part of a formal response to an Aug. 2 inspection report of a facility. The report noted that Novartis apparently first became aware of manipulated data concerning a gene therapy last March, but waited to inform the agency until after the treatment was approved in May.
The move comes amid an ongoing uproar over the way Novartis handled the disclosure, which has cast a pall over the drug maker and opened it to harsh criticism for failing to alert the FDA sooner. Meanwhile, although agency officials say the $2.1 million gene therapy still appears to be safe and effective, and would have been approved anyway, the company may face civil and criminal charges.