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FDA's Sharpless: We Will Be 'Vigilant' Against Data Fraud

The topic took up just the last four minutes of his talk, but Acting Food and Drug Administration Commissioner Ned Sharpless’ words were clear about the value of data integrity: If you bring “bad” data to the FDA, we will go after you.

Speaking at the close of a day-long conference hosted by Research!America, Sharpless never mentioned what prompted his warning, namely the scandal that unfolded in August. The FDA revealed then that months prior to FDA approval in May, a subsidiary of Novartis AG knowingly submitted falsified animal research data in support of a medication for a sometimes-fatal pediatric spine condition. The drug was already under fire because of its high price tag—$2. 1 million.

FDA learned of the falsifications from the firm two months after approval; some terminations were triggered, but overall, both Novartis and FDA ultimately said no safety concerns have arisen as a result, and the drug, Zolgensma, is staying on the market for now (“FDA: Some Animal Research Data Behind New $2.1M Gene Therapy Drug Were ‘Manipulated,’” RRC E-Alerts: August 8, 2019).

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