FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident
FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident
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Democratic senators push data-challenged gene therapy Zolgensma into the center of the drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question the US FDA’s decision to withdraw its proposed rule about data falsification in clinical and nonclinical studies last year. Did the FDA do the right thing by abandoning a proposed rule that, as they state, is not needed to protect research subjects or ensure integrity of clinical trial data?
Publisher: Pinksheet
- Description
Democratic senators are outraged about Zolgensma, the most expensive medication in American history with a price tag of $2.1 million, calling it “a scandal that smacks of the pharmaceutical industry’s privilege and greed”. The senators have pressed acting commissioner Sharpless to bring the hammer down on Novartis, but also question the US FDA’s decision to withdraw its proposed rule about data falsification in clinical and nonclinical studies last year. Yet the FDA states that the ruling is not needed to protect research subjects or to help ensure integrity of clinical trial data submitted to them in support of marketing applications and petitions for product approvals.
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