FDA Policy/General

FDA Gets Funding Until 12/8 Under Emergency Disaster Bill

The House and Senate have approved a bill that provides funding for FDA and other government agencies until 12/8, as well as emergency disaster funding for damage caused by hurricanes Harvey and Irma. The legislation is now being sent to the president for his signature.

While the FY 2018 Continuing Resolution (CR) keeps FDA and the government running in the short term, it also disadvantages the agency, according to an analysis by the Alliance for a Stronger FDA. The advocacy group says that it hampers FDA’s long-term planning, hiring and new non-emergency projects that could be delayed because they are not “continued” from FY 17.

“Further, the status quo is not being fully maintained under the CR,” the Alliance observes. “Rather than providing funding at the FY 17 level, the CR actually calls for spending at a level that is 0.6791% less. The reduction will cost FDA about $3 million in BA [budget authority] funding (rough estimate). This is an unpleasant surprise for an agency that can ill-afford to have its budget cut, even by a small amount. It is uncertain whether the reduction will be carried over into final appropriations bills. The impact of the CR on user fees is unknown at this time. We expect that this will be clarified within the next week or so; certainly well before the CR takes effect on 10/1.”

Additionally, the Alliance notes that the agency could be better off if a “mega-bus” appropriations bill, which includes several agency full-year funding measures, continues to make its way through the House and eventually becomes law as soon as possible.

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