Novartis‘ alleged data manipulation with respect to a submission to the FDA and subsequent approval of Zolgensma, the world’s most expensive pharmaceutical. selling for $2.1 million, led the news across the world, to widespread outrage. Preet Bharara’s* quote from a few years past once again, unfortunately, echo’d across the world’s press „Novartis is a repeat offender“.

The F.D.A. said Novartis data was “mismanaged” or “manipulated,” though declined at this early point in the investigation to say whether the information was deliberately falsified.

The FDA’s investigation is a new blow to Novartis’s reputation following revelations last year that it paid $1.2 million to President Donald Trump’s former lawyer Michael Cohen and allegations it paid kickbacks to doctors. In response to these missteps Vasant Narasimhan, Novartis CEO, had announced on taking office he had instigated steps to raising standards and managing risk. He also named a new ethics head, Dr Klaus Moosmayer, who has been very visible in 2019 at anti-corruption and compliance summits around the world.

The FDA also in inspecting Novartis’ Irvine, California, manufacturing plant in recent weeks found several deficiencies, including not fully following quality control procedures.

Novartis in a communique dismissed criticism that it allegedly withheld information about data inaccuracies from the FDA.

Here an overview from worlds leading news outlets:

Aljazeera: Novartis withheld data problem before drug approval

https://www.aljazeera.com/ajimpact/novartis-withheld-data-problem-drug-approval-fda-190807052836235.html35.html

New York Times: Novartis C.E.O. Defends Company’s Decision to Withhold False Data From the F.D.A.

https://www.nytimes.com/2019/08/07/health/novartis-fda-gene-therapy.html

Reuters: Novartis says it knew of Zolgensma data problems before U.S. approval

https://www.reuters.com/article/us-usa-fda-novartis/novartis-says-it-knew-of-zolgensma-data-problems-before-u-s-approval-idUSKCN1UX1KA

Washington Post: FDA: Gene therapy maker submitted manipulated data before drug was approved

https://www.washingtonpost.com/health/2019/08/06/gene-therapy-maker-knew-data-manipulation-before-fda-approval-agency-says/

Wall Street Journal: FDA Says Data Manipulated for Novartis Gene Therapy Drug

https://www.wsj.com/articles/fda-says-data-manipulation-occurred-in-trials-of-world-s-priciest-drug-11565116881

ABC News: FDA says Novartis withheld data problem before drug approval

https://abcnews.go.com/Health/wireStory/fda-novartis-withheld-data-problem-drug-approval-64813655

Fortune: Novartis Defends $2.1 Million Gene Therapy After FDA Data Manipulation Claims

https://fortune.com/2019/08/06/fda-novartis-gene-therapy-data-manipulation/

CBSnews: World's priciest drug approved after "data manipulation," FDA alleges

https://www.cbsnews.com/news/fda-zolgensma-novartis-stock-down-after-allegation-of-data-manipulation-before-approval-of-worlds-most-expensive/

MSN: FDA: Novartis Hid Data Manipulation While Seeking Approval of $2.1 Million Drug

https://www.msn.com/en-us/money/companies/fda-novartis-hid-data-manipulation-while-seeking-approval-of-dollar21-million-drug/ar-AAFqXux

Financial Times: FDA probing ‘data manipulation’ from early tests of Novartis drug

https://www.ft.com/content/95b6a0b2-b87b-11e9-8a88-aa6628ac896c

Swissinfo: Novartis rejects suspected data manipulation in US

https://www.swissinfo.ch/eng/gene-therapy_novartis-rejects-suspected-data-manipulation-in-us/45145374

Zolgensma will remain on the market despite the FDA investigation.

*Preet Bharara was the eminent United States Attorney for the Southern District of New York from 2009 to 2017. Bharara earned an exceptional reputation as the USA‘s foremost prosecutors of public corruption and Corporate crime. He was fired by Donald Trump.