Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Be­fore Pan­dem­ic — the FDA ripped No­var­tis for its de­ci­sion to keep the agency in the dark about ma­nip­u­lat­ed da­ta used in its ap­pli­ca­tion for Zol­gens­ma while its mar­ket­ing ap­pli­ca­tion for the gene ther­a­py was un­der re­view.

Civ­il and crim­i­nal sanc­tions were be­ing dis­cussed, the agency not­ed in a rare broad­side at one of the world’s largest phar­ma com­pa­nies. No­table law­mak­ers cheered the an­gry reg­u­la­tors on, urg­ing the FDA to make an ex­am­ple of No­var­tis, which field­ed Zol­gens­ma at $2.1 mil­lion — the cur­rent record for a one-off ther­a­py.

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