FDA Policy/General

‘Seismic’ Loper Bright Impact Not Yet Seen: Attorneys

The long-term impact of the Supreme Court’s Loper Bright decision in the health landscape remains unclear, according to an article in the Yale Journal on Regulation. Immediately after the decision was announced, many commentators warned of a coming “seismic” impact.

Written by staff and a student at the Yale Law School Solomon Center for Health Law & Policy, the article says that while the decision overturning 40 years of judicial deference to federal agency interpretations of ambiguous laws has produced only relatively modest effects in most health-related cases, it reopened the door for new rulings on some of the most controversial modern healthcare regulations.

“And Loper Bright means that any new court decisions on those controversial regulations … will take on extra importance because Loper Bright holds that once a court decides a statute’s single best meaning, there is no room for future policy shifts,” the authors write.

In Loper Bright, the article says, the high court not only ended the previous Chevron deference regime but also took the position that every statute can have only one “single, best meaning,” and that such meaning must be decided by a court, not an agency. “This ended new presidential administrations’ ability to reinterpret statutes and effectively created a race to the courthouse to “lock in” a single best interpretation of a statute,” it says.

The authors found that of the over 4,000 citations to Loper Bright that appeared in court decisions or case filings within a year of the decision, only a few hundred were in litigation involving a federal health agency. “Most courts that cited the opinion did so in passing or stated that it did not impact their decisions, often citing other precedent, such as the fact that a court previously interpreted a statute one way, as controlling or significant,” they add.

The article looks at some of the old decisions that were relitigated in light of Loper and the new questions that were raised under it.

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