FDA Policy/General

Committee to Look at Risk Communication Plan

The FDA Risk Communication Advisory Committee meets 11/7 to discuss and make recommendations on the agency’s draft Strategic Plan for Risk Communication and Health Literacy, intended to clarify how FDA can communicate the benefits and risks of regulated products to target audiences more effectively and thus promote better decision making. The plan includes a strategic framework, performance indicators, a performance monitoring plan, and a short-term implementation plan.

The strategic plan’s overarching outcome is “increased accessibility to actionable and accurate FDA communication and benefit/risk information.” Four contributing outcomes on which the overarching outcome depends are:

increased use of clear communication best practices and plain language in developing messages;
increased use of more targeted messages and communications;
improved efficiency of internal operations for writing and developing communications; and
improved dissemination of FDA’s communication and information.

In addition to commenting on this plan, advisory committee members will hear presentations on some of the agency’s external communications. At its February meeting, the committee had recommended that FDA conduct an environmental scan of its risk communications. In advance of the November meeting, the agency is giving committee members a report on 128 external communications coming from CBER, CDER, CDRH, the Center for Tobacco Products, the Office of the Commissioner, and the Office of Regulatory Affairs.

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