Novartis pledges to quickly notify FDA of data issues after scandal

Novartis, under fire for keeping data issues secret for months, pledged to more quickly notify the FDA about data manipulation concerns affecting pending marketing applications, STAT reported.

The drugmaker said it would report to the FDA any "credible allegation" of data-manipulation within five business days of learning about it.

The move comes after a recent scandal in which the drugmaker did not report manipulated data in its application for its $2.1 million gene therapy drug Zolgensma until after it was approved by the agency.

Novartis made the promise publicly at an investor meeting Sept. 9, though they already made the commitment to the FDA last month as part of a formal response to the FDA's investigation.

The FDA has threatened to file civil and criminal charges against Novartis for failing to report the data until after the drug's approval.

Agency officials said Zolgensma still appears safe and effective and would have been approved anyway, STAT reported.

Read the full report here.

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