Grassley Pressures Drug Manufacturer over Data Manipulation

WASHINGTON – Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, sent a letter to Novartis International AG CEO Vasant Narasimhan requesting documents relating to AveXis, a subsidiary of Novartis, manipulating data about a treatment for infants suffering from spinal muscular atrophy. The treatment, Zolgensma, is the most expensive drug in the world.

 

“…AveXis became aware of the data manipulation before the FDA approved Zolgensma but intentionally withheld that information from the FDA until after the product was approved,” Grassley wrote. “Such conduct is reprehensible and could have an adverse effect on patients. Accordingly, the conduct ought to be investigated and, as appropriate, punished to the fullest extent of the law.”

 

Text of the letter is available HERE and below.

 

Mr. Vasant Narasimhan

Chief Executive Officer

Novartis International AG

 

Dear Mr. Narasimhan,

 

On August 6, 2019, the Food and Drug Administration (FDA) issued a public statement about Novartis’ gene therapy product, Zolgensma, a life-saving treatment for infants with spinal muscular atrophy and the most expensive drug in the world. That statement noted that the FDA approved the drug on May 24, 2019, and then on June 28, 2019, AveXis, a subsidiary of Novartis, informed the FDA that it issued manipulated data “that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application…” for Zolgensma. The statement further noted that AveXis became aware of the data manipulation before the FDA approved Zolgensma but intentionally withheld that information from the FDA until after the product was approved. Such conduct is reprehensible and could have an adverse effect on patients. Accordingly, the conduct ought to be investigated and, as appropriate, punished to the fullest extent of the law.

 

To better understand the decision-making process that led to the intentional withholding of important information from the FDA, please provide the following no later than August 23, 2019:

 

1.      All records relating to the withholding of Zolgensma data from the FDA.

2.      All records relating to Novartis’ internal inquiry into Zolgensma data manipulation.  

3.      On what date did Novartis learn that it issued manipulated data to the FDA relating to Zolgensma? 

4.      On what date did Novartis open an internal inquiry into the manipulated data?

5.      On what date did Novartis conclude the internal inquiry?

6.      How many Novartis employees have been terminated for manipulating Zolgensma data? 

7.      What steps have you taken to ensure that manipulated data is not sent to the FDA for future products? 

 

Thank you for your attention to this important matter.  Should you have questions, please contact Joshua Flynn-Brown of my Committee staff at 202-224-4515.