Drugs

Don’t Change 180-day Generic Exclusivity: Yale Journal

Researchers say issues involving innovator and generic drug companies strategically “parking” 180-day generic drug exclusivity to delay generic entry and competitive drug markets now occur infrequently. When parking does occur, the authors write in the Yale Journal of Health Policy, Law, and Ethics, it tends to relate to changes in FDA review standards over which generic manufacturers have little or no control.

“Recently proposed changes to the Waxman-Hatch Act’s statutory framework are therefore unlikely to substantially improve generic availability,” the researchers say. “In addition, such changes risk upsetting existing incentives for generic manufacturers to bring Paragraph IV challenges in the first place by increasing uncertainty with respect to the ability to obtain or retain exclusivity and the extent to which the exclusivity period will be shared.”

Additional research may find that strategic parking has simply become less transparent, the article says, rather than less frequent. But, “until additional evidence of the frequency, length, and financial impact of strategic behavior emerges, Congress should refrain from revising a system that has helped increase the share of generic drugs from 19% in 1984 to 90% in 2020, and that has led to generic drug prices in the United States that are generally among the lowest in the world. As revisions to the law are considered, legislators must recognize that any changes could inadvertently undo gains, as well as close loopholes. Legislators should avoid statutory amendments that undermine existing incentives to file generic applications containing Paragraph IV certification.”

The article reviews the history of 180-day exclusivity, evaluates the types of strategic behavior that remained after significant changes to Waxman-Hatch were made in 2003, and considers whether three recent legislative proposals are likely to offer improvements.

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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