How did regulators and lawmakers respond?
The FDA said it would likely have delayed approval and could pursue civil or criminal penalties; five senators called it "unconscionable"; and former Commissioner Gottlieb wrote he suspected there would be "wrongdoers here. And consequences."
The FDA said it would likely have delayed approval had it known, and that it would use its full authorities, including possible civil or criminal penalties. Former FDA Commissioner Scott Gottlieb wrote that he suspected there would be "wrongdoers here. And consequences." Five Democratic senators, including Bernie Sanders and Elizabeth Warren, urged the FDA to hold AveXis accountable, calling it "unconscionable" for a company to provide manipulated data to rush a product to market. AveXis was also required to submit BLA supplements for FDA review. Novartis pledged greater openness about data integrity. Details of any final penalty were not prominent in the public record reviewed for this article.