FDA Policy/General

FDA Floats Food-Animal Antibiotic Use Group

FDA has established a docket to receive public comments on a Reagan-Udall Foundation report outlining a potential framework for establishing a public/private partnership (PPP) to collect and analyze antimicrobial use (AMU) data from food-producing animals. An agency statement (contains a link to the report) says the report summarizes the work completed over a multi-year cooperative agreement funded by the agency. Under the agreement, the foundation convened a working group to evaluate the feasibility of developing and maintaining a system to collect and report AMU data in the U.S., it says.

The report includes information about AMU standardization and the protection of data confidentiality. It also summarizes stakeholder input and public comments on potential PPP objectives, membership, organizational structure, and financing, the statement says.

FDA says antimicrobial use data “can help foster antimicrobial stewardship and slow the development of antimicrobial resistance because it provides insight into what drugs are being used, how much of the drugs are being used, and how they are being used. FDA does not currently have the authority to require end users to report AMU data. However, because these data would be vital in helping to guide stewardship efforts, FDA has been exploring, with the foundation’s assistance, whether a PPP could balance the need for public health information with practical concerns of the veterinary professionals and producers who would voluntarily contribute to the data repository.”

The statement says that while FDA is interested in comments on all aspects of the report, it particularly would like information on:

cost estimates for external data partners to develop and sustain the collection of AMU data in animals, recognizing the diversity of data sources across animal sectors;
cost estimates for the setup and maintenance of the AMU data repository under the PPP framework described in the report;
descriptions or suggestions on the type of organizations most appropriate to coordinate a national AMU data repository; and
descriptions or suggestions on how a steering committee should be structured and membership roles and responsibilities long-term.

Comments will be received through 10/31.

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