Novartis makes new data integrity commitment
Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on Monday that the company will be more proactive in reporting data integrity issues to the FDA.
“We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible allegation related to data integrity,” Narasimhan said.
He also said Novartis has responded to the FDA’s Form 483 and is making documents available as requested, while reiterating that the data manipulation uncovered at the San Diego site “does not impact the safety, efficacy or quality of Zolgensma.”
The pledge follows sharp comments made last week by acting FDA Commissioner Ned Sharpless, who did not mention Novartis by name, but clearly singled the company out in his remarks before the Research!America 2019 National Health Forum.
While addressing data fraud, Sharpless said: “So it should not be surprising to me now at FDA that if people will lie to get their paper published or get their grant funded, then people will also lie to get a billion dollar medical product approved.”
Five Democratic senators (including presidential hopefuls Bernie Sanders and Elizabeth Warren) also pounced on the data manipulation last month, saying this “scandal smacks of the pharmaceutical industry’s privilege and greed.” They also called on the FDA to hold Novartis accountable and they questioned whether FDA has plans to re-issue a final rule on falsified data that the agency withdrew last September.
Novartis’ commitment Monday to report allegations of data integrity transgressions within five business days brings up an interesting gray area in FDA’s regulations for when companies should report such issues that do not result in serious adverse events.
As Greenleaf Health experts and former FDA officials wrote on the Food and Drug Law Institute’s website, “While it is clear suspension or termination of the trial requires the sponsor to notify FDA, sponsors are often perplexed about when to notify FDA when the protocol noncompliance issue is significant, but yet not so significant that it requires suspension or termination of the trial.”
In addition, they note that in the case of emergency deviations made to protect the life or well-being of a subject, the FDA must receive notice within five working days of the deviation, although the FDA’s regulations “are not so clearly defined concerning when the sponsor’s duty arises to report a serious breach of protocol that does not result in a serious adverse event, but may cause FDA to question the reliability of the data.”
But the experts note that proactive reporting to the agency and working with the FDA can be helpful. Sponsors “often will find that it is advantageous to report data integrity issues to FDA soon after discovery rather than waiting for FDA to discover the data integrity issue during an inspection,” they added.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.