FDA Policy/General

Senate Passes $159 Million FDA Spending Boost

The Senate has passed a minibus FY 2019 appropriations package that includes a $159 million (5%) boost for FDA over the FY 2018 enacted level. The minibus (HR 6147) provides $2.97 billion in discretionary funding for the agency, which is about $150 million less than the House has approved (see earlier story). Including industry funded user fees, FDA would have $5.49 billion for FY 2019, which is $292 million above FY 2018.

The bill allocates $88.5 million for medical product initiatives, including full funding for the Oncology Center of Excellence; $15 million for food safety initiatives; and $66 million for opioid prevention efforts. The bill also provides $70 million as authorized in the 21st Century Cures Act.

An earlier comparative analysis by the Alliance for a Stronger FDA noted that the House and Senate have both shown support for the agency, “but at different levels and with somewhat different priorities.” For example, the House committee bill would provide $12 million for outsourcing facilities (drug compounding) but the Senate committee did not provide any new funding in this area. While the House bill would provide $60 million to advance the use of real-world data, the Senate bill again would not provide any new funding, the Alliance said.

Another area that is ignored by the Senate spending measure is the regulation of digital health technologies. The House version calls for $40 million to help establish a new risk-based regulatory paradigm for digital health technologies that would allow companies to market lower-risk products without FDA premarket review and market higher-risk products following a streamlined FDA premarket review. And to help develop a new platform for drug development, the House bill seeks $45 million, while the Senate bill would provide only $8.2 million. The initiative would help FDA with up-to-date scientific standards and assessment tools, as well as evolving technologies, methods, and approaches for drug reviews. “Without these tools, the agency’s ability to support innovation and review applications will lag behind the latest science and inhibit innovation,” the Alliance warned.

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