FDA’S DAY AT SCOTUS — Don’t expect the Supreme Court to take a sledgehammer to the FDA’s ability to regulate tobacco. The high court heard oral arguments on Monday from Texas-based Triton Distribution, which asked the court to affirm a lower court’s ruling that the agency reconsider its applications to sell flavored liquids containing nicotine that e-cigarettes heat for a user to inhale. Triton and a partner e-cigarette product maker, Vapetasia, also argued that the FDA was not consistent about the type of data it needed to support approval of the products. But several justices did not seem convinced by the company’s lawyer — instead appearing inclined to support the agency. Liberal justices repeatedly seemed to back the FDA’s stance that the underlying law backs its actions to deny e-cigarette products. “Everybody basically knows that flavors are particularly dangerous in terms of kids starting the use of smoking products,” Justice Elena Kagan said. And a handful of conservatives questioned if there is a remedy that would have a practical impact.
“I'm curious what relief looks like in this case, because the companies can always reapply,” Justice Brett Kavanaugh said. Timing: A decision is expected by the end of the Supreme Court term in June, but the FDA could potentially change its regulatory approach to e-cigarettes even in absence of a ruling favorable to the industry. President-elect Donald Trump pledged to “save” vaping on his Truth Social site in September. William Schultz, an attorney at Zuckerman Spaeder who was HHS general counsel under former President Barack Obama, said it is always hard to predict how the court will rule. But he noted the conservative justices were not hostile to the position the government took during the oral arguments.
“It’s a new program, and you're going to expect the agency on product approvals to learn and kind of incorporate what it learned as it does the reviews,” said Schultz, who is a consultant to the Campaign for Tobacco-Free Kids, an advocacy group that wants to ban flavored tobacco products.
Curtis Gannon, the Justice Department deputy solicitor general defending the FDA, argued that the agency could have simply given no guidance and just relied on the underlying statute when issuing authorizing decisions. But many industries regulated by the FDA welcome the recommendations from the agency because they lend transparency into its thinking. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. If you work in the Senate and see that your boss has a meeting lined up with any of the president-elect’s health agency picks, do let your morning hosts know! Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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