FDA Policy/General

Midterms Threaten FDA Funding: Alliance

FDA’s fiscal year 2019 Congressional appropriations, which are part of a four-bill minibus, are “imperiled” after being superseded by other spending bills and lawmakers push for an early recess in order to campaign in the mid-term elections, according to an analysis by the Alliance for a Stronger FDA. Without a signed spending bill, FDA’s funding would be tied to a nine-week continuing resolution (CR) that would extend until at least 12/7. “A CR is undesirable because it would constrain FDA’s ability to start and continue new programs, including those for which money was requested in the President’s FY 19 budget request,” the group says. To add to the uncertainty, President Trump has threatened to not sign the pending spending bills and cause a government shutdown out of frustration that increased funding for his signature border wall between the U.S. and Mexico is absent in the measures.

Despite the dire warning, the Alliance notes that there is still some optimism that Congress will be able to pass the FDA-included minibus before adjournment. A conference agreement would probably need to be ready for a vote next week if there is any chance of avoiding the CR funding. “Resolution is also made more difficult because the House posture has been to load up the funding bills with policy riders, while the Senate funding bills were comparatively clean,” the group adds.

Senate Appropriations Committee chairman Richard Shelby (R-AL) was quoted in the Alliance analysis as saying: “...we are very close to an agreement on four additional bills - Interior, Financial Services, Transportation, and Agriculture [which includes FDA]. While we still have differences to resolve on each of the bills, none of them are insurmountable, in my judgement. So we will continue to work diligently, and hopefully return to the floor soon with yet another conference report in hand.”

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