Novartis Pledges More Transparency on Data Concerns
September 09 2019 - 12:53PM
Dow Jones News
By Denise Roland
Novartis AG, under fire for keeping a data-manipulation issue
under wraps for several months, vowed to more quickly disclose any
similar concerns in the future.
Chief Executive Vas Narasimhan on Monday told investors at an
event in London that Novartis has committed to notify the Food and
Drug Administration within five business days of any "credible
allegation" of manipulation of data that had been submitted to the
agency for drug approval.
The FDA last month said the Swiss company could face criminal
penalties for holding back a data-manipulation concern with gene
therapy medicine Zolgensma during its approval process. Novartis
notified the FDA of the concern in late June, a month after the
drug was approved, despite the issue being known inside the company
since the middle of March.
Dr. Narasimhan has said the company wanted to investigate the
specifics of the manipulation before bringing the concern to the
agency. He said he was made aware of the issue in early May after
an initial investigation found the allegations were credible.
But the timeline of those decisions has raised suspicions from
the agency, and some politicians, that Novartis kept the issue
under wraps because it didn't want to delay the approval of
Zolgensma.
The medicine, which costs in the range of $2.1 million for a
one-time infusion, treats children with an especially devastating,
sometimes fatal form of spinal muscular atrophy. It is one of the
first in a wave of gene therapies that promise to cure certain
intractable diseases with one dose. They work by supplying a
functioning version of the gene at fault.
The FDA gave Novartis the green light to sell Zolgensma in late
May and the company put it on sale at a price of $2.1 million,
making it the world's most expensive drug. Dr. Narasimhan has said
the approval timeline for Zolgensma wasn't a factor.
"It's difficult for us to exercise judgment without it being
later considered maybe not the best judgment, so we're just taking
judgment out of the equation," Dr. Narasimhan said of the five-day
pledge at the investor event, which focused environmental, social
and corporate governance.
The FDA has said the data manipulation, which related to mouse
studies carried out to compare different batches of Zolgensma,
didn't affect its view that the gene therapy is safe and effective.
It referred the matter to its Office for Criminal Investigations.
Submitting false data to the agency as part of a new-drug
application could be a crime if investigators prove the actions
were intentional and not an oversight.
The episode has also drawn criticism from several high-ranking
politicians including Democratic presidential candidates Sens.
Elizabeth Warren of Massachusetts and Bernie Sanders of Vermont,
and Sen. Chuck Grassley (R., Iowa).
Write to Denise Roland at Denise.Roland@wsj.com
(END) Dow Jones Newswires
September 09, 2019 12:38 ET (16:38 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Novartis (NYSE:NVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novartis (NYSE:NVS)
Historical Stock Chart
From Apr 2023 to Apr 2024