FDA will overhaul diagnostics regulation if Congress doesn’t

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Oct 28, 2022 View in browser   By Katherine Ellen Foley , David Lim and Lauren Gardner With help from Megan R. Wilson Driving the Day FDA's headquarters in White Oak, Maryland. | Sarah Silbiger/Getty Images CALIFF, SHUREN PUSH FOR VALID ACT — Top FDA officials are becoming more pointed in their warnings that if Congress fails to take action this year on an overhaul of regulation of diagnostics and laboratory-developed tests, the agency might pursue rulemaking instead, David reports. "I really congratulate the sponsors and the HELP Committee for putting forward what is a very modern, rational approach that we believe will drive innovation and provide appropriate safeguards," FDA Center for Devices and Radiological Health Jeff Shuren said at the MedTech Conference this week in Boston. "We think there are some minor tweaks to make in it, but we're supportive of the approach it takes." For decades, most laboratory-developed tests — which are generally developed and used by a single laboratory — were used on a limited basis, and the FDA did not require them to undergo review. But they are increasingly used to diagnose complex diseases or to determine if a cancer patient is a match for an immunotherapy, according to Elizabeth Hillebrenner, associate director for scientific and regulatory programs in FDA's Center for Devices and Radiological Health. "That's why FDA believes that enforcement discretion policy no longer makes sense here," Hillebrenner said. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Best of luck to all the athletes in the Marine Corps Marathon this weekend! Send tips, feedback and your favorite recovery meals to David Lim ( dlim@politico.com or @davidalim ), Lauren Gardner ( lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley ( kfoley@politico.com or @katherineefoley ). TODAY ON OUR PULSE CHECK PODCAST , David Lim talks with Ruth Reader about the biggest takeaways from the MedTech conference. Plus, researcher Eric Bressman discusses a new study which found that sending patients automated text messages after they've left the hospital can reduce their chances of readmission.   TUNE IN TO THE PULSE CHECK PODCAST: Keep your finger on the pulse of the biggest stories in health care by listening to our daily Pulse Check podcast. POLITICO's must-listen briefing decodes healthcare policy and politics, and delivers reality checks from health professionals on the front lines. SUBSCRIBE NOW AND START LISTENING .     Industry Intel 'NO-WIN SITUATION:' CLASHES WITH BOARD PART OF BIO CEO DEPARTURE — Michelle McMurry-Heath, hired to lead the Biotechnology Innovation Organization and serve as a change agent at the 30-year-old trade association, stepped down earlier this month over a number of factors, including behind-the-scenes political disagreements, POLITICO's Megan R. Wilson reports. Her resignation comes in part from clashes with influential executives on the association's board. These executives wanted the group to be more outspoken and reactive on issues, such as voting restrictions and abortion rights, and even Russia's invasion of Ukraine, six people with knowledge of the events told Megan. "This kind of all came to a head because you've got this group of CEOs — not all of them, but remember, these are the people that hired her — I really do believe that they wanted to turn BIO into a social change organization, in addition to being a trade association," one of the six said. "She was in a no-win situation in that respect." Megan talked with more than a dozen people — including current and former BIO staff, lobbyists and a health care executive — about the internal dynamics of the organization and the circumstances around McMurry-Heath's departure. They told her that while her leaving surprised many, it was fueled by a complex mix of behind-the-scenes factors, including staffing and organizational changes — such as pandemic-driven layoffs that some acknowledge could have been handled better. The turmoil at the industry group, which boasts more than 1,000 members in the biopharmaceutical and agriculture sectors, comes as Democrats are set to implement one of the most sweeping drug reform packages in the past decade and underscores the challenge of leading a large board with disparate policy goals and views about its mission. Eye on FDA FDA Commissioner Robert Califf is pictured. | Andrew Harnik/AP Photo CALIFF: FDA CLOSER TO FINALIZING HYBRID WORK POLICY — FDA has spent the past few months conducting an "intensive survey" of staff that will inform a hybrid work policy, Commissioner Robert Califf told medical device executives at the MedTech Conference this week. "In the next few weeks we'll be making some decisions about what sort of hybrid environment we adopt," Califf said. FDA POSTPONES MEETING ON OTC BIRTH CONTROL  — On Wednesday, the FDA said it's delaying a meeting of its independent expert advisers to consider making a birth control pill available without a prescription. The meeting was originally scheduled for Nov. 18; there is no rescheduled date yet. HRA Pharma, the drugmaker, is petitioning for its contraceptive Opill to be available over-the-counter and in July submitted additional information at the FDA's request. The agency now says it needs more time to review. The FDA also notified the manufacturer that the date by which regulators aim to render a decision — mandated by the Prescription Drug User Fee Act — has been extended 90 days. That date is not yet public. Normally, the time for responding to such applications is at least 10 months, meaning a final decision may not come before the second half of 2023. Tobacco FDA DENIES MARKETING ORDERS FOR FULLY VETTED MENTHOL E-CIG CAPSULES — The FDA issued marketing denial orders on Wednesday for Logic's menthol vape capsules that work with Logic's currently authorized e-cigarettes, Katherine reports. The capsules, which fit the Logic Pro and Logic Power devices that the FDA authorized in March, are the first menthol-flavored capsules to receive agency denial orders after undergoing a full scientific review. In a statement, the FDA said that the youth appeal of non-tobacco flavors factored into its decision, as demonstrated by the recent results of the National Youth Tobacco Survey. Because of the risk of youth uptake and the lack of evidence that these capsules were better at helping adult smokers switch from conventional tobacco products to vaping, the agency deemed them inappropriate for market. Logic will appeal the decision. "We will exercise our right to appeal the denial orders through all applicable administrative and legal pathways," Corrado Mautone, the president of Logic, said in a statement to POLITICO. At the Agencies CMS TO RELEASE TCIT PROPOSAL BY APRIL — CMS plans to issue a long-awaited proposed rule before April that would replace a Trump-era regulation designed to create an accelerated coverage pathway for medical devices, said Tamara Syrek Jensen, director of the CMS coverage and analysis group, at a Tuesday MedTech Conference panel. "You want the three-legged stool; you want coverage, coding and payment," Syrek Jensen said. "Those don't all have to happen on the same day of FDA market authorization, but there needs to be a path with clear milestones of when you can accomplish that. I've heard various dates thrown around, obviously not two years, but within zero to six months." Earlier this month in JAMA , CMS Chief Medical Officer Lee Fleisher and CMS Principal Deputy Administrator Jonathan Blum laid out a framework for the forthcoming proposed rule — the spiritual successor to a Trump-era effort that was put on ice at the start of the Biden administration, David reports. Pharma Moves Don Ashley will retire on Nov. 23 as director of the Office of Compliance within the FDA's Center for Drug Evaluation and Research. Deputy Director Jill Furman will serve as the acting office director. Robert Davis will become the new chairman of Merck's board on Dec. 1 after Kenneth Frazier retires at the end of November. Mike Evans, who has spent the past nine years as Democrats' chief counsel and deputy staff director for the tax-writing Senate Finance Committee, isrejoining K&L Gates as a partner. Document Drawer The FDA issued guidance on preventing and developing treatments for Clostridioides difficile infections on Thursday.   STAY AHEAD OF THE CURVE: Our Future Pulse newsletter will continue to bring you the biggest stories at the intersection of technology and healthcare, but now five times a week. Want to know what's next in health care? Sign up for our Future Pulse newsletter. If you aren't already subscribed, follow this link to start receiving Future Pulse .       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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