Healthcare

FDA approved world’s priciest drug using faulty data

By Kimberly Leonard
Published August 6, 2019 7:11pm ET
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FDA approved world’s priciest drug using faulty data
President Trump signed into law the FDA Reauthorization Act of 2017 on Friday. It reauthorizes a program in which drug and device makers pay the FDA a fee for every new product application, and the agency uses that money to hire more people and speed up approvals. (AP Photo/Andrew Harnik, File) | Andrew Harnik

The Food and Drug Administration is taking action against pharmaceutical giant Novartis for failing to report faulty data to government regulators about its $2.1 million drug that treats a paralyzing, fatal genetic disease.

The FDA plans to “use its full authorities to take action, if appropriate, which may include civil or criminal penalties” against the company’s gene therapy subsidiary, AveXis Inc., FDA Commissioner Ned Sharpless said in a statement Tuesday.

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