Novartis Delay on Data Manipulation Probed -- WSJ
23 Agosto 2019 - 9:02AM
Dow Jones News
By Thomas M. Burton
This article is being republished as part of our daily
reproduction of WSJ.com articles that also appeared in the U.S.
print edition of The Wall Street Journal (August 23, 2019).
WASHINGTON -- Federal regulators examining test data
manipulation for a gene-therapy drug made by Novartis AG are
zeroing in on the company's two-month delay in launching a formal
inquiry, according to documents and interviews.
The drug, Zolgensma, is used to treat a sometimes fatal form of
spinal muscular atrophy in children and costs about $2.1 million
for a one-time infusion. The Food and Drug Administration said this
month that it wasn't informed about the data manipulation until
after it approved use of the drug May 24.
FDA officials, who subsequently inspected the company's control
testing lab in San Diego, noted that Novartis became aware of the
problem March 14, but didn't open a formal probe until two months
later, with no explanation for the gap.
"There is no documentation," FDA investigators Scott T. Ballard
and Mihaly S. Ligmond wrote in their Aug. 2 report, as to why the
probe "was not opened until 15 May, 2019, when the initial
allegation is documented as having been reported on 14 March
2019."
In a statement to The Wall Street Journal, Novartis said that
during those two months, it "conducted an independent investigation
with the support of external counsel to determine the extent of
data discrepancies and whether they could be explained."
Novartis said the internal probe had to be conducted in a "very
confidential manner" so that senior executives at AveXis -- its
Illinois-based unit that produced the drug -- wouldn't attempt to
interfere. The company also said it plans to file a full written
explanation of the gap to the FDA as early as this week.
In its statement, the company said that the investigation it
formally launched in May was a "full technical quality
investigation by our quality organization...requiring significant
time and resources, and the extensive review of physical and
electronic documents, test data and laboratory notes."
Novartis, in a report filed with the FDA about the data issue,
said it began a formal investigation May 8.
Novartis announced last week that it had replaced two research
executives at AveXis who led the research into the medicine, chief
scientific officer Brian Kaspar and research chief Allan Kaspar.
Allan Kaspar couldn't be reached. John Hueston, an attorney for his
brother Brian Kaspar, said "he has cooperated in the internal
investigation and categorically denies any wrongdoing."
In interviews, FDA officials said that two months to open an
investigation seems excessive, especially when FDA action on a
major drug was pending. They said the agency should have been
notified as soon as the company suspected data manipulation, and
that the data problems, had they been known, could have delayed
approval.
The FDA, in an official statement Thursday, said, "While in some
instances it may be reasonable for a firm to make a determination
of the merit of a complaint in order to decide whether or not to
initiate an investigation, each decision must be considered on a
case-by-case basis. We are not able to comment specifically on the
circumstances of this case."
In a Twitter message Aug. 6, FDA Commissioner Ned Sharpless said
agency officials "rely on truthful scientific data to make
regulatory decisions, and we take the issue of data integrity very
seriously." The FDA, he said, "will use its full authorities to
take action, if appropriate, which may include civil or criminal
penalties."
The data manipulation occurred in animal tests accompanying
human clinical testing and involved giving various strengths of
Zolgensma to mice to measure how long they lived. This was a small
part of the overall testing.
Both the company and the federal agency said that the data
manipulation, if known, wouldn't have affected the final decision
on Zolgensma, which is considered the world's most expensive
drug.
Write to Thomas M. Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
August 23, 2019 02:47 ET (06:47 GMT)
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