Drugs

Suggestions to Revise Hatch-Waxman ‘Skinny Label’ Provisions

A Congressional Research Service (CRS) background paper on “‛Skinny Labels’ for Generic Drugs Under Hatch-Waxman” raises changes that Congress could consider if it wanted to clarify the provisions. The paper gives extensive background on the generic drug approval process under Hatch-Waxman and the role of so-called skinny labels that allow ANDA filers to exclude some uses of a drug that are still covered by patents.

Problems have arisen, the paper says, from challenges to the use of codes recorded in FDA’s Orange Book and from suits involving skinny labels and patent infringement liability.

CRS identifies several possible issues that Congress could consider in clarifying the skinny label provisions. It could require FDA to monitor Orange Book patent information, or expand current procedures for challenging that information. For example, it says, Congress could create an independent cause of action to correct Orange Book patent information.

Another thing for Congress to consider, CRS says, is whether to clarify when generic manufacturers using a skinny label should be liable for indirect patent infringement through a statutory safe harbor.

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