A clean slate for FDA’s e-cig application pile?

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jul 02, 2024 View in browser   By David Lim and Lauren Gardner Programming note: We’ll be off this Friday for the Fourth of July but will be back in your inboxes on Tuesday. Driving The Day Sen. Dick Durbin blasted the FDA for its yearslong inaction on e-cigarette applications. | Francis Chung/POLITICO VAPING REVIEW ESTIMATE MISSED — The FDA has not yet taken action on some applications for e-cigarettes from vaping companies, including dominant players Juul and Vuse, but that could soon change. In April, the agency told the U.S. District Court for the District of Maryland that it expected to take action on all remaining applications tied to a federal lawsuit by June 30. But the agency missed that self-imposed deadline despite authorizing several NJOY menthol-flavored e-cigarettes last month. “The FDA is committed to completing review of the unprecedented amount of premarket tobacco product applications it has received as soon as feasible,” Brian King, director of the FDA’s Center for Tobacco Products, said. “The review of these applications is of the utmost public health importance, and we do not make decisions lightly — we must make sure final decisions issued on these applications are appropriate on both the scientific merits and the law.” Under a federal court order that requires quarterly updates, the FDA must issue another status report by July 22 — and tobacco regulation watchers anticipate the agency will authorize or deny several applications in the coming weeks. “There’s been a several-year-old long pattern of missed deadlines,” said Cliff Douglas, CEO of Global Action to End Smoking, the advocacy group previously known as the Foundation for a Smoke-Free World. “What we hear said is that we should anticipate them announcing authorizations or denial of authorizations by [July] 12.” Senate Majority Whip Dick Durbin (D-Ill.) slammed the FDA for the lack of action on the applications, noting years have passed since the initial court-imposed Sept. 9, 2021, deadline. “The failure to meet yet another deadline [on June 30] suggests FDA is not meeting its obligations under the court order,” Durbin said, calling on the agency to take strong action against the sale of unauthorized e-cigarettes. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. FDA Commissioner Robert Califf has taken to JAMA along with former CMS Chief Medical Officer Lee Fleisher and others to discuss why evidence generation in clinical trials matters to insurance company or government payers. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     Eye on the FDA Makers of cosmetics must register their facilities with the FDA. | Eric Gay/AP COSMETICS IN FOCUS — Monday marked the start of the FDA’s enforcement of key provisions of the 2022 law overhauling cosmetics regulation after a six-month delay. Most manufacturers and processors must now register their facilities — updating any changes within 60 days and renewing registration every two years — and submit product ingredients with annual updates to the agency. Talc to come: Meanwhile, the FDA’s proposed testing methods for identifying asbestos in talc-containing products have been sitting at the Office of Management and Budget for review since Jan. 2. The law directed the agency to release the proposal by the end of December 2023. An FDA spokesperson didn’t comment on the delay. The American Association for Justice, which represents trial attorneys, is scheduled to meet with OMB on July 9 to discuss the proposal. Scott Faber, senior vice president for government affairs for the Environmental Working Group, a nonprofit advocacy group, told Prescription Pulse it’s up to the Biden administration to make the rule official. The FDA is statutorily required to release the final rule 180 days after public comment closes on the proposal. “Asbestos in talc is killing people, and Congress and the FDA have done their part,” he said. In the Courts 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. Research Corner NIH TRIALS NASAL COVID VACCINE — NIH has opened enrollment for a Phase I trial investigating the safety of a nasal vaccine against Covid-19, the agency said Monday. The vaccine could provide more wide-ranging protection against emerging viral variants, the agency said. National Institute of Allergy and Infectious Diseases scientists designed and tested the experimental vaccine. WHAT WE'RE READING The Federal Trade Commission has reportedly opened an investigation into Teva Pharmaceuticals over its refusal to pull about a dozen patents for asthma and chronic obstructive pulmonary disease from a federal registry known as the Orange Book, which would encourage generic competition, according to The Washington Post.   Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more.     Document Drawer The FDA issued draft guidance containing recommendations for medical device companies on device design outputs needed for assessing drug-delivery performance.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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