Drugs

FTC Seeks Restored Disgorgement Authority

The FTC says it will advocate for Congress to act quickly and advance legislation to strengthen its powers in the wake of a 4/22 Supreme Court decision that curtails its authority to seek monetary restitution from companies engaged in deceptive practices, such as pharmaceutical company anticompetive measures.

The unanimous opinion by Justice Stephen Breyer held that Section 13(b) of the Federal Trade Commission Act does not give the FTC the authority to seek “equitable monetary relief such as restitution or disgorgement.” It further said that the section authorizes injunctions only, not monetary relief. Breyer added that the agency still has the authority to obtain restitution on behalf of consumers under other sections of the FTC Act.

A PhRMA brief to the court argued against the FTC monetary penalties, particularly in patent cases involving so-called “reverse payments.” PhRMA said FTC used Section 13(b) to obtain “substantial payments in cases in which the underlying legal theory was far from settled and where the defendants had a well-founded belief that the conduct was lawful... In these cases, the agency alleged that an incumbent pharmaceutical manufacturer who exercised its patent rights in accordance with the special procedures of the Hatch-Waxman Act was in fact paying a generic competitor not to enter the market. The agency has obtained some of its largest 13(b) payments under this theory.”

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