Drugs

Allergan Pays $750 Million on Namenda Switch Scheme

Allergan and its Forest Laboratories subsidiaries have settled for $750 million a lawsuit brought by direct purchasers of Alzheimer’s drug Namenda (memantine) that alleged Forest illegally delayed generic competition. The settlement does not recognize any wrongdoing and resolves litigation that was scheduled to go to trial this week.

Plaintiffs alleged that Forest entered into an illegal agreement with its prospective generic competitor, Mylan, and then orchestrated a “hard switch” scheme whereby patients on immediate-release Namenda were switched to extended-release Namenda XR. As a result of Forest’s conduct, purchasers contended they were injured from the “loss of earlier, unconstrained, lower priced generic competition,” attorneys said.

At one point, HHS issued a brief criticizing Actavis (Forest subsequently acquired Actavis) for its plan to withdraw twice-daily Namenda IR from the market, a move that “appears designed to force a highly vulnerable population suffering from a severe chronic illness to shift to a reformulated version of the product for the purpose of limiting generic competition and preserving monopoly profits.” It said that the federal government in particular would overpay relative to what it would have paid had the generic product been permitted to freely compete with the newer reformulated Namenda XR once-daily product. “Such practices stress public budgets and reduce the ability to promote value-based health care use,” the issue brief said.

In 2014, then-New York attorney general Eric T. Schneiderman filed an antitrust lawsuit seeking to block Actavis from forcing Alzheimer’s patients to switch to Namenda XR. “Once patients switch to the new drug, Namenda XR, it’s likely that they will remain on that medication even after the Namenda generics hit the market due to the practical difficulties of switching back, thus allowing Actavis to insulate its profits from competition,” according to a news release at the time. That case was eventually settled too.

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