FDA says some data used to approve world’s most expensive drug was faulty

https://www.msn.com/en-us/health/health-news/fda-says-some-data-used-to-approve-worlds-most-expensive-drug-was-faulty/ar-AAFqWvw

The world’s most expensive drug was approved using data that was partially faulty, the Food and Drug Administration said Tuesday.

© Getty Images FDA says some data used to approve world’s most expensive drug was faulty

The drug, Zolgensma, was approved in May at the sky-high price of $2.1 million, and treats the deadly childhood disease of Spinal Muscular Atrophy.

Now, the FDA is saying it has learned that some of the product testing data used to approve the drug was faulty.

The FDA also said the company that makes the drug, AveXis, a unit of Novartis, learned the data was faulty before the drug was approved, but waited until after approval to tell the FDA.

“The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties,” Peter Marks, an FDA official, said in a statement.

Despite the problems with some of the data, the FDA said it “remains confident that Zolgensma should remain on the market.”

The FDA said “only a small portion” of the product testing data was faulty due to a “data manipulation issue.”

The revelation is sure to increase scrutiny of Novartis, which was already facing criticism from drug pricing advocates for the price tag of the drug. The company did not immediately respond to a request for comment.

“The totality of the evidence demonstrating the product’s effectiveness and its safety profile continues to provide compelling evidence supporting an overall favorable benefit-risk profile,” said the FDA’s Marks. “However, the integrity of the product testing data used in the development of the product’s manufacturing process is still a matter that we are continuing to evaluate and take very seriously.”

Filed under: General Problems