FDA Policy/General

NIH Awards $15 Million in Grants to Study Genomics

NIH has issued four new grants to support research on the ethical, legal and social questions raised by advances in genomics research and the increasing availability of genomic information. “The projects will examine the use of genomic information in the prevention and treatment of infectious diseases; genomic information privacy; communication about prenatal and newborn genomic testing results; and the impact of genomics in American Indian and Alaskan Native communities,” an NIH release says. The $15 million in grants will support the following research projects over the next four years:

Ethical, Legal and Social Issues for Precision Medicine and Infectious Disease : Johns Hopkins Berman Institute of Bioethics and Johns Hopkins University in Baltimore will use $4.2 million to examine the ethical implications of using genomic information to help manage the prevention, control and treatment of infectious diseases. The researchers will develop and conduct three pilot projects that study how genomic information affects infectious disease research, public health policy and clinical practice.
Genetic Privacy and Identity in Community Settings: Vanderbilt University School of Medicine will use $4 million to study privacy risks associated with genomic information. Researchers will examine the effectiveness of legal and policy efforts to reduce privacy risks, and study the likelihood that lapses in protecting genomic information allow people to be identified. They will develop policies to prevent the loss of privacy that could lead to the use of personal genomic information for unintended purposes, such as to discriminate in decisions about employment and insurance.
Utah Center of Excellence in Ethical, Legal and Social Implications Research: University of Utah will use $3.9 million to study how family members communicate about prenatal and newborn screening, including how test results and risks are communicated, decision-making and couples communication.
Center on American Indian and Alaska Native Genomic Research: University of Oklahoma will use $3.6 million to examine how the use of genomic information in medical care could potentially impact American Indian and Alaska Native communities and health care systems. The university will partner with the Chickasaw and Lakota Sioux tribes and communities and the Southcentral Foundation in Anchorage, AK to study awareness, knowledge and attitudes about genomics in these communities.

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