WHITHER THE ADMINISTRATIVE STATE — Yet another Supreme Court decision Monday could fundamentally alter how industry challenges federal regulation. In a 6-3 decision split along ideological lines, the high court ruled that the six-year statute of limitations under the Administrative Procedure Act that governs the federal rulemaking process begins once a company is “injured by final agency action.” That means firms can sue federal agencies for relief from rules once they’re subject to them — even if that means a business that debuts in 2018 is beginning to grapple with a regulation dating to 2011, which is what happened in the case in question. In her dissent, Justice Ketanji Brown Jackson wrote that the decision will amplify the effect of last week’s court decision to overturn the Chevron doctrine, the precedent in which courts deferred to federal agencies’ reading of ambiguous laws as long as their interpretations were reasonable. “Now, every legal claim conceived of in those last four decades — and before — can possibly be brought before courts newly unleashed from the constraints of any such deference,” she wrote. CHEVRON SHOWDOWN — Former FDA Chief Counsel Rebecca Wood, who led the agency’s legal office during the Trump administration, described the Supreme Court’s Chevron decision as a “seismic shift” that could take time to play out. “I’ve certainly been watching the [laboratory-developed tests] case as a potential first example of where a decrease in Chevron deference could really make a difference,” said Wood, who is a partner at Sidley Austin. Over time, one area of foundational FDA authority is worth keeping an eye on, according to Wood. If the FDA’s interpretation of the statutory concept of substantial evidence for drug approvals is given less deference, it could have a broad impact. “I think it’s an interesting question,” Wood said. Former Sen. Richard Burr (R-N.C.) said the ruling does not come as a surprise — and puts more onus on Congress to write better laws. That could be critical in a post-Chevron environment, according to former FDA Commissioner Mark McClellan. “You’re in this fuzzier zone where the statute doesn’t clearly and neatly apply to the regulatory topic in question,” McClellan said. The main takeaway: It will likely take longer to develop new medical products and for the FDA to make policy calls and write rules, according to former agency attorneys. GRANT FRAUD CHARGES — A federal grand jury indicted a medical professor last week on charges that he defrauded the National Institutes of Health of about $16 million in federal grant money, the Justice Department said. Hoau-Yan Wang of the City University of New York School of Medicine is accused of falsifying scientific data in grant applications to support a potential treatment and test for Alzheimer’s disease. The drug in question, simufilam, is in late-stage clinical trials.
| 
No comments:
Post a Comment