All over! The FDA quietly closed its investigation into Novartis Zolgensma's violations.

Late last year, Novartis was mired in data manipulation of gene therapy Zolgensma.
at the time, the FDA said strongly that it "will take full action and will not rule out civil or criminal penalties."
"but it now seems unlikely that neither will happen.
the agency has quietly closed its investigation into Novartis violations and said it will not punish for altering data and delaying reporting, according to a recent report on BioPharma Dive.
Zolgensma was approved by the FDA in May 2019, becoming the world's first and only gene therapy for spinal muscular dystrophy (SMA).
the approval of Zolgensma was a landmark, but the subsequent data manipulation issue added a gray light to that milestone.
last August, the FDA noted that Novartis' application contained tampering data and did not notify the agency until a month after Zolgensma's approval.
fact, Novartis was aware of the problems as early as last March.
expressed strong dissatisfaction with the move and said it would investigate it seriously.
at the time, some analysts said the announcement was highly unusual and a strong warning sign for other companies in the fast-growing field of gene therapy.
However, after a seven-month investigation, the FDA decided not to impose regulatory penalties on Novartis.
, the FDA classified its results as "Voluntary Action Indicated (voluntary action to improve), VAI."
this means that the FDA found irregularities during the inspection process, but did not exceed the threshold for regulatory action. "The FDA has completed a review of the information and records of the inspections, the evidence gathered, the company's responses, and corrective actions for the results of the inspections, and classified the results as VAI," a
FDA spokesman said.
based on a review of the available information, the FDA continues to consider Zolgensma to be safe and effective for its intended use.
throughout the investigation, the FDA maintains that there is no evidence that human data has changed.
" last August, the FDA examined Novartis' gene therapy company, AveXis, and released 483 forms.
the form to document defects and irregularities found by the inspectors (FDA investigators) who perform inspections during the drug company's inspection.
the drug companies under test need to respond formally to the defects, after which the FDA will decide whether to issue a formal warning.
Novartis submitted a response at the end of August last year, promising to retrain employees and improve quality control oversight.
the company blamed a large part of AveXis' two executives, Brian and Allan Kaspar, who were fired in mid-August but later publicly denied wrongdoing through their lawyers.
Novartis also promised to notify the FDA within five working days of credible allegations of data integrity issues related to drug applications in the future.
last week, Novartis released a new clinical report by Zolgensma that disclosed 483 forms of classification and outlined the FDA's decision. A spokesman for
Novartis said: "We are pleased with this positive outcome and reaffirm our strong commitment to data integrity and transparency in our partnership with regulators."
" Zolgensma is the first gene therapy to treat SMA, theoretically a one-time cure, but the cost of the treatment is as high as $2.125 million.
Novartis is introducing an installment plan for Zolgensma, which allows families to pay within five years, an average of $425,000 a year.
, Zolgensma expects to save more on health care systems than the current long-term treatment of more than $4 million over a decade.
About 200 infants received Zolgensma treatment in 2019, with sales of $361 million, according to Novartis' earnings report.
Source: 1, FDA lets Novartis off hook in Zolgensma data manipulation 2, No sanctions for Novartis as FDA ends review of gene therapy.