Drugs

FDA Resists Criticism of Postmarketing Requirements: Study

Dalhousie University researcher Matthew Herder says that since FDA gradually shifted to a model of lifecycle regulation in the 1990s, it is not simply an agency in transition but rather an agency on guard against a set of larger political threats to its mandate. Writing in Milbank Quarterly, Herder says “this can be characterized as a state of institutional incumbency in which the agency is engaged in an effort to reproduce key features of the regulatory system — in concert with regulated industries and others — while simultaneously sanctioning significant changes to the regulatory standards FDA has long applied, to the detriment of public health.”

The article says that under its lifecycle regulation, FDA increasingly relies on postmarketing requirements to encourage studies of drug safety and effectiveness following regulatory approval. The article examines the range of legal, institutional, and political challenges FDA faces in the context of lifestyle regulation.

The author says he found that insufficient resources and coordination within FDA, inadequate legal authorities, and the political economy of withdrawing an approved indication in the face of opposition from companies and patients all contribute to the observed shortcomings in FDA’s use and enforcement of postmarketing requirements. “Further,” he says, “FDA is fully aware of these challenges, yet is seemingly resigned to and resistant to criticism of its use of postmarketing requirements.”

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