FDA Policy/General

Senate Committee OKs $80 mil. FDA Spending Boost

The Senate Appropriations Committee has approved an FY 2020 FDA appropriations bill (view details here and here), which includes $3.148 billion in discretionary funding for the agency — $80 million above the FY 2019 enacted level. The measure includes a $7 million increase for medical countermeasures initiatives, $10 million to reduce pathogens in the blood supply, $6 million for compounding prescription drugs, $7 million for advancing food safety, $8 million for responding to food outbreaks, and $2 million for Cannabidiol activities, according to the Alliance for a Stronger FDA. Additionally, the bill includes $15 million to address infrastructure needs at FDA buildings and laboratories. The House-reported numbers are $3.26 billion in discretionary funding in the bill, which is $184 million above the FY 2019 enacted level, the group says.

Meanwhile, the Alliance notes that the House 9/19 passed a FY 2020 continuing resolution, which is intended to act as a vehicle to prevent a government shutdown. The measure would fund the federal government from 10/ 1 until 11/21 in order to complete the appropriations process.

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

Read more

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