U.S. Senate Finance Committee Chairman Chuck Grassley, R-Iowa, has asked Novartis to provide company records and details about data manipulation related to FDA approval of its $2 million gene therapy Zolgensma, according to EndPoints News.
The Swiss pharmaceutical company learned that some of its employees had manipulated data in the Zolgensma application in March, but instead of telling the Food and Drug Administration immediately, Novartis conducted its own investigation and submitted the results to the FDA in late June, about one month after Zolgensma was approved by the FDA.
In a letter to Novartis CEO Vas Narasiman, Mr. Grassley asked the company to provide all records about the issue, including results of its internal inquiry and the number of employees terminated as a result of the error.
Mr. Narasiman was given a deadline of Aug. 23 to respond to the letter.