Biologics

What Happens to FDA in a Budget Shutdown?

In a Hyman, Phelps & McNamara FDA Law Blog post, principal regulatory device and biologics expert Richard Lewis, who was an FDA reviewer and compliance officer during the 2018-2019 five-week government shutdown, describes what such a funding gap means for the agency and its regulated industries. The post recognizes that the government is now funded through 3/14 and will shut down after that unless there is a new budget or continuing agreement in place.

Lewis writes that staff in positions that are exempt from appropriations may be asked to remain working even if other employees are furloughed. CBER, CDER, and CDRH are largely funded through user fees, he says, and submissions under the various user fee agreements can continue in process. He says that in 2018-2019, reviewers with active user fee files continued their jobs without interruption.

The post makes these additional points:

a short or moderate agency shutdown should not make a meaningful change to the review of NDAs, BLAs, PMAs, 510(s), IDEs, and INDs;
written response meetings and teleconferences should proceed, but face-to-face meetings may not be possible due to support staff furloughs;
most normal surveillance operations are funded by congressional appropriations and thus would be shut down; and
while submissions to FDA that have an associated user fee will not be accepted during a shutdown because the agency has no way to process the company payment, submissions not associated with a user fee will be accepted and reviewed.

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