Novartis caught plenty of flack with last week’s revelation that its FDA application for gene therapy Zolgensma contained manipulated data and that the company didn't inform regulators until after its approval. Now it's facing a congressional investigation.
In a letter to Novartis CEO Vas Narasimhan, Senate Finance Committee chair Chuck Grassley said the company's conduct was “reprehensible and could have an adverse effect on patients.” The influential senator struck up an investigation, asking the drugmaker to send in its records for the incident.
Grassley wants to drill into the timeline of events, from when the company learned about the problem to its internal investigation and on to its disclosing the problem to the FDA. And he wants info on Novartis' response—from the number of employees who have been or will be fired to the company's plan for preventing similar problems in the future.
A Novartis spokesman said the company received the letter and is reviewing Grassley's requests.
The FDA last week disclosed that Novartis' Zolgensma application contained manipulated data and that the drugmaker didn't inform regulators about the irregularities until after the med's approval. The agency approved the drug in May to treat certain spinal muscular atrophy patients under two years old.
A scandal erupted, and Narasimhan hosted a conference call with analysts the following day to detail the company’s side of the story. Novartis execs said a scientist with the company’s gene therapy outfit AveXis notified the drugmaker of data manipulation in mid-March. Then, the company started and finished an internal probe before bringing the issue to the FDA. According to the FDA, Novartis notified the agency of the data manipulation in late June.
Meanwhile, the agency had approved Zolgensma in late May without knowledge of Novartis’ probe. Last week, the regulator went public, and acting FDA chief Ned Sharpless said the agency is considering criminal or civil punishments.
The drugmaker and regulators determined Zolgensma is safe and effective and should remain on the market.
Democratic lawmakers piled on days later, writing Sharpless to urge him to use his “full authorities to hold AveXis accountable for its malfeasance, including through all appropriate criminal, civil, and regulatory actions against the company.”
“Anything short of a forceful response would signal a green light to future pharmaceutical misbehavior,” they added.
The Zolgensma data manipulation revelations are the latest regulatory misstep for Novartis amid a series of scandals in recent years. Back in 2013 and 2014, authorities in Japan discovered the company manipulated trial data and failed to report side effects. The company has also faced bribery allegations around the world and an embarrassing episode with President Donald Trump's former personal attorney Michael Cohen last year.
Narasimhan has said he's making compliance a priority, but the Zolgensma issue shows the company still has some work to do.