FDA Policy/General

FDA to Win or Lose $40 mil. in Continuing Resolution: Alliance

FDA could win or lose $40 million in the current fiscal year (FY) 2017 continuing resolution depending on whether Congress allows the omnibus measure to proceed with spending recommendations adopted last year or allow new Trump Administration projections that would cut many government-wide programs to make way for defense and immigration enforcement spending increases, according to an analysis by the Alliance for a Stronger FDA. The worst-case scenario comes from Congress accepting president Trump’s recommendations, which would have FDA absorbing $40 million in cuts through “administrative savings and reflecting slower than anticipated hiring,” the group says.

On the budget horizon, the Alliance remains concerned about the Trump Administration’s blueprint on next year’s (FY 2018) spending proposal that would increase user fees by $1 billion (see story). The problem is that the current user fee reauthorization agreements (FY 2018 to FY 2022) are advancing in Congress without any resistance, and it is very unlikely they will be renegotiated to increase fees over the next five years. This puts pressure on Congressional appropriators, the Alliance says, to find an extra $1 billion in FDA’s budget authority to make up for these missing user fee increases — no easy task that could result in significant cuts in FY 2018.

The Alliance says it is now working to have the administration’s Office of Management and Budget “reconsider” the FY 2018 blueprint proposal, “dropping it before they submit the president’s final budget request. Failing that, the president’s proposal could result in FDA losing hundreds of millions of dollars in the FY 18 appropriation process — cuts that would dramatically reduce FDA’s ability to carry out its responsibilities for safe and effective medical products and safe foods. Even programs that receive substantial user fee funding could wind up with significantly less resources. Food safety could be particularly hard hit.”

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