Novartis CEO says organization can 'stand proud' after hiding manipulated data from FDA

Novartis CEO says organization can 'stand proud' after hiding manipulated data from FDA
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Drug company Novartis is defending its decision to withhold information from the Food and Drug Administration (FDA) about partially faulty data in its application for approval of a $2.1 million drug. 

Novartis said it didn't tell the FDA about the faulty data until after the agency approved Zolgensma, used to treat spinal muscular atrophy in infants, because it was completing its own internal investigation. 

"Typically what we did in this case is exactly what we do in every case: informing the agency once we actually understand the information we have in hand," said Rob Kowalski, Novartis head of regulatory affairs, said in a conference call Wednesday.


Novartis CEO Vas Narasimhan said the organization can "stand proud that we tried to do the right things in this instance." 

“We understand the agency has a different perspective, which we respect, but we’ve tried to be transparent, thorough, science-based and, most importantly, patient-oriented to ensure that we never compromised patient safety, efficacy, or product quality during any moment during all of this.”

The FDA said Tuesday the company that makes the drug, AveXis, a unit of Novartis, learned the data was incorrect before the drug was approved, but waited until after approval to tell the FDA. 

The drug was approved in May but Novartis became aware of the issue in March. 

Novartis officials said Wednesday the "small number" of scientists involved in the inaccuracies were exiting the company. 

The FDA has indicated it might pursue civil or criminal penalties against the company, and that it would have delayed the drug's approval if it knew about the manipulated data.

Both the FDA and Novartis said the drug is still safe to use and will continue to be sold.