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Presidential Commission Looking to Study Ethical Issues of Animal Rule in Pediatric Populations

Posted 28 June 2012 | By

A Presidential Commission in charge of studying bioethics wants to know: what are the ethical issues associated with studying medical countermeasures in children?

In a 28 June Federal Register posting, the Presidential Commission for the Study of Bioethical Issues-a commission formed in 2009 specifically to look at ethical issues related to "biomedicine and related areas of science and technology"-said it wants to look deeper into the legal, ethical and social issues of studying countermeasures as the result of a request from the Department of Health and Human Services' Secretary, Kathleen Sebelius.

Medical countermeasures have been a topical concern for the US Food and Drug Administration (FDA) and other federal agencies after a series of Anthrax attacks in 2001 left authorities scrambling to contain the deadly outbreak with limited resources at their disposal.

Shortly thereafter FDA passed what it calls its "Animal Rule"-an approval pathway through which manufacturers can apply for conditional approval of a medical countermeasure intended to treat a rare or potentially fatal virus or bacteria. Unlike normal testing requirements, products approved through the Animal Rule pathway would only require testing in human analogues-pigs, chimpanzees, and other similar animals-to gain approval. Testing the safety and efficacy of the products in humans is deemed to be too dangerous given the potential for serious adverse events.

"While significant progress has been made in the development of medical countermeasures for adults, the development of similar products for children has lagged, in part because of challenges in conducting safety and immunogenicity studies," the Commission explained. "The Commission is particularly interested in policies, practices, research, and perspectives on ethical issues associated with pre- and post-event studies testing the safety, dose, and/or immunogenicity of medical countermeasures for and with children."

Specifically, the commission said it is interested in determining a conceptual framework through which it can consider "risk and societal value when reviewing pediatric clinical research in general and for medical countermeasures in particular." It wants that framework to include different types of information, criteria for proposed studies, ethical issues, scientific and public health strategies, communication strategies, and the role of communities in designing and supporting research.

Comments on the bioethical issues are due to the commission by 27 August 2012.

Read more:

Federal Register - Request for Comments on Ethical Issues Associated with the Development of Medical Countermeasures for Children

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