Drugs

HHS Inspector General Probe on Alexion Practices

Alexion Pharmaceuticals is reportedly under investigation by the HHS Office of Inspector General (OIG) over its support for charities that aid Medicare patients, already being investigated by the U.S. Attorney’s Office in Massachusetts. Earlier this year, Alexion said it had received a subpoena asking for documents about this. Bloomberg News says it recently received a response from a Freedom of Information Act request from OIG that said that there was an “open and ongoing investigation” into the rare disease drug maker.

Bloomberg notes that Alexion has been under government scrutiny over its business practices since its chief executive and financial officers resigned last year amid allegations that the company engaged in improper sales practices. Since then, new CEO Ludwig Hantson has been cleaning house as he focuses the company on compliance.

A Bloomberg investigation in May found a widespread culture of aggressive sales at Alexion. It reported that sales staff pressured doctors to keep patients on the drug Soliris, company nurses warned patients who wanted to stop taking therapy that doing so could lead to blood clots, and the drugmaker’s close relationships with nonprofits gave it special access to patient information. Alexion also allegedly signed deals with lab companies that would alert it when new patients were found — sharing detailed information that helped it look for new potential customers.

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