Data Manipulation Not Common, But Happens "More Than I Would Have Expected," US FDA's Sharpless Says
As fallout from the Novartis Zolgensma data manipulation incident continues, US FDA acting commissioner Norman Sharpless notes that "at some level we have to trust the sponsors."
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Sponsors should notify US FDA quickly when they detect data quality issues in preclinical and clinical research, particularly for applications under review, experts say in a rebuke to Novartis’ delayed notification about Zolgensma data manipulation.
Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.
Ned Sharpless has been acting head of the US FDA for five months but has not yet been formally nominated for the permanent post. The emergence of another new name as a possible candidate underscores how uncertain the transition still is.