Drugs

Feds Join Questcor Whistleblower Case

The federal government has intervened in two whistleblower False Claims Act cases alleging that Mallinckrodt’s Questcor Pharmaceuticals unit improperly promoted an expensive multiple sclerosis drug and paid kickbacks to doctors who prescribed the drug, H.P. Acthar Gel. Reuters reports the Justice Department decided to intervene after investigating the whistleblowers’ allegations.

Questcor reportedly increased Acthar’s price for a single vial from $2,000 to $23,000 in 2007 (well before it was acquired by Mallincrodt in 2014). Mallinckrodt says the price today is $38,892. The suits were filed in 2012 and 2013 by two former Questcor employees. A Mallinckrodt statement said the company disagrees with the allegations and has been in “advanced settlement talks with the government over the past several months.

In one of the suits, a former employee claims the company tried to boost Acthar sales by paying doctors illegal kickbacks in the form of bribes, speaker fees, and consulting deals. It also said the company sales staff used deceptive and misleading marketing tactics to promote the drug for off-label uses and treatment regimens.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome