Morning Briefing
Summaries of health policy coverage from major news organizations
Novartis Pledges New Integrity Efforts In Letter To FDA Detailing Manipulation Of Data On New Drug
The Wall Street Journal: Novartis Details Manipulation Of Data On Gene Therapy, Responding To FDA Probe
Novartis AG said that an internal probe of data manipulation at one of its drug-development units was hindered by two brothers, both senior researchers whom it later fired. The Swiss drug giant said in a newly disclosed letter to the U.S. Food and Drug Administration that its months-long investigation into the issue was “significantly drawn out” due to a “lack of cooperation and categorical denial of the allegations” by the brothers. Novartis and the FDA disclosed in August they had identified data manipulation in testing of a gene-therapy treatment that was conducted by AveXis, a Chicago-based company Novartis bought in 2018 for $8.7 billion. The treatment, developed by AveXis and later dubbed Zolgensma, is now the world’s most expensive drug. (Roland, 9/24)
PoliticoPro: Novartis Responds To FDA, Promises Boosted Data Oversight After Zolgensma
The company also promised in a letter to FDA made public today that it will share with the agency any "credible allegation" concerning the data integrity of a new drug within five days of receiving it. The Swiss drugmaker was responding to FDA’s questions about data errors that the company and its subsidiary AveXis submitted in the application for spinal muscular atrophy treatment Zolgensma, which the agency approved in May. The manufacturers were aware of the data problem before FDA approved Zolgensma, but did not inform the agency until June 28, FDA said. (Owermohle, 9/24)
Stat: Novartis Expands Recall Of Heartburn Meds To U.S. After Finding Carcinogen
After running tests, the Sandoz unit of Novartis (NVS) has expanded its recall of heartburn medicines containing ranitidine and is now pulling the products from the U.S. The move comes one week after the drug maker halted worldwide distribution of heartburn medicines and regulators in the U.S and Europe disclosed the capsules may contain high levels of a carcinogen. At the time, Sandoz also issued a recall in some European countries and Canada, but did not take the same step in the U.S. while testing was underway. (Silverman, 9/24)
