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Democratic senators urge FDA to take action against drug company that hid faulty data

Democratic senators urge FDA to take action against drug company that hid faulty data
© Greg Nash

A group of Democratic senators is urging the Food and Drug Administration (FDA) to take action against a drug company that hid falsified data from the government while seeking approval for a $2.1 million gene therapy. 

Sen. Dick DurbinDick DurbinOvernight Health Care: Takeaways on the Supreme Court's Obamacare decision | COVID-19 cost 5.5 million years of American life | Biden administration investing billions in antiviral pills for COVID-19 COVID-19 long-haulers press Congress for paid family leave Joe Manchin keeps Democrats guessing on sweeping election bill MORE (Ill.) led the senators, which include 2020 presidential candidates Sens. Bernie SandersBernie SandersOVERNIGHT ENERGY:  EPA announces new clean air advisors after firing Trump appointees |  Senate confirms Biden pick for No. 2 role at Interior | Watchdog: Bureau of Land Management saw messaging failures, understaffing during pandemic Overnight Health Care: Takeaways on the Supreme Court's Obamacare decision | COVID-19 cost 5.5 million years of American life | Biden administration investing billions in antiviral pills for COVID-19 Democratic senators press PhRMA over COVID-19 lobbying efforts  MORE (I-Vt.) and Elizabeth WarrenElizabeth WarrenOvernight Health Care: Takeaways on the Supreme Court's Obamacare decision | COVID-19 cost 5.5 million years of American life | Biden administration investing billions in antiviral pills for COVID-19 Democratic senators press PhRMA over COVID-19 lobbying efforts  Schumer vows to only pass infrastructure package that is 'a strong, bold climate bill' MORE (D-Mass.), in pushing the FDA to take "appropriate" criminal, civil and regulatory actions against AveXis for not disclosing inaccuracies in its product testing data until after it was approved. 

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AveXis, a subsidiary of Novartis, knew of the issue in March, but didn't tell the FDA about it until June 28. The drug, Zolgensma, which treats spinal muscular atrophy in infants, was approved for sale by the FDA on May 24. 

It is the most expensive drug in American history.

"It is unconscionable that a drug company would provide manipulated data to federal regulators in order to rush its product to market, reap federal perks, and charge the highest amount in American history for its medication," the senators said in a letter to Ned Sharpless, the acting FDA commissioner. 

The FDA announced the news this week and said it might pursue criminal or civil penalties against the company. The FDA also said it would have delayed approval of the drug had it known about the faulty data. 

However, Novartis officials said this week it delayed telling the FDA about the faulty data because it was conducting its own internal investigation. 

"Typically what we did in this case is exactly what we do in every case: informing the agency once we actually understand the information we have in hand," Rob Kowalski, Novartis's head of regulatory affairs, said in a conference call Wednesday.

But the Democratic senators argued Novartis hid the data because it was "in a rush to make a profit." 

"Such greed cannot be condoned by the FDA ... Anything short of a forceful response would signal a green light to future pharmaceutical misbehavior."

Both the FDA and Novartis said the drug is still safe to use and will continue to be sold.