FDA Policy/General

House GOPers Seek IG Probe on FDA Lab Safety

Republican members of the House Energy and Commerce Committee have asked Health and Human Services inspector general Christi Grimm to assess the adequacy of FDA’s oversight and support of its Office of Laboratory Safety (OLS). The request follows a decade-old investigation into the 2014 discovery of boxes containing vials of smallpox virus and other hazardous biological agents in an FDA Laboratory on the National Institutes of Health (NIH) campus.

In a 10/18 letter to Grimm, committee leaders said: “We are deeply concerned that the FDA is not meeting important federal safety requirements to protect its employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories.” They ask that she include in her assessment the following concerns raised by the committee’s oversight:

FDA is not complying with Occupational Safety and Health Administration (OSHA) requirements for annual unannounced inspections
FDA has not fully implemented and closed out the recommendations issued four years ago from the Government Accountability Office related to the OLS.
FDA may not be sufficiently supporting its laboratory safety program with adequate funding and resources.
FDA may not be providing the OLS with the authority and visibility to promote safety.

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