Senate Finance Comittee Chairman, Chuck Grassley calls on Novartis to reveal details of data scandal
pharmafile | August 13, 2019 | News story | Research and Development | AveXis, Chuck Grassley, Novartis, Zolgensma, sfc
Chuck Grassley, Chairman of the Senate Finance Committee, has demanded that Novartis give up details on the faulty data scandal surrounding Zolgensma.
In a letter to Novartis CEO Vas Narismhan, Senator Grassley described the Swiss firm’s actions as “reprehensible” as he suggested that “the conduct ought to be investigated and, as appropriate, punished to the full extent of the law.”
The Iowa Senator thus called on Novartis to offer up information on:
- All records relating to the withholding of Zolgensma data from the FDA
- All records relating to Novartis’ internal inquiry into Zolgensma data manipulation
- On what date did Novartis learn that it issued manipulated data to the FDA relating to Zolgensma?
- On what date did Novartis open an internal inquiry into the manipulated data?
- On what date did Novartis conclude the internal inquiry?
- How many Novartis employees have been terminated for manipulating Zolgensma data?
- What steps have you taken to ensure that manipulated data is not sent to the FDA for future products?
Senator Grassley said this information should be put forward no later than 23 August 2019. Novartis said it had received Grassley’s letter and was now reviewing the request.
Senator Grassley’s letter follows that of five senators, including presidential candidates Bernie Sanders and Elizabeth Warren, to acting FDA commissioner Ned Sharpless, asking that the agency hold Novartis to account over the faulty Zolgensma data.
Louis Goss
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