Drugs

Mallinckrodt to Pay $15.4 Million on False Claims Charges

Mallinckrodt (formerly Questcor Pharmaceuticals) says it expects to pay $15.4 million under an agreement in principle it has reached to resolve False Claims Act allegations that it used a foundation as a conduit to pay kickbacks in connection with its drug H.P. Acthar Gel from 2010 through 2014. The Justice Department filed a complaint in a Pennsylvania federal court alleging that the company used the kickback scheme to free it to raise the price of a vial of Acthar from $50 to $32,000.

In two whistleblower suits, the government says the company used the foundation to pay illegal kickbacks in the form of copay subsidies for Acthar so it could market the drug as “free” to doctors and patients, despite significantly increasing the drug’s price.

In a statement, Mallinckrodt says its settlement agreement does not involve an admission of guilt and it believes that the Questcor action was lawful and appropriate under an HHS Inspector General advisory opinion at the time. The company says it is its policy to resolve legacy legal matters in a reasonable and manageable way when that it possible.

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