FDA could thwart its own smoking-cessation push

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Jul 18, 2023 View in browser   By David Lim and Katherine Ellen Foley Presented by 340B Health Driving The Day The FDA told e-cigarette makers Logic it wouldn’t authorize its menthol products because of the risk to youth. | Logic Technology LLC STANDARDS FOR MENTHOL VAPES — The FDA is poised to finalize a rule banning menthol cigarettes — which make up nearly 40 percent of the market — in an effort to encourage smokers to quit. But it hasn’t approved a new smoking-cessation aid in nearly 20 years and has such high standards for authorizing less-harmful menthol e-cigarettes, some public health experts fear the ban may fall short of its desired effect. Not all menthol smokers will just quit, said David Méndez, associate professor of health management and policy at the University of Michigan. The FDA has stated that e-cigarettes are a safer alternative for smokers who switch entirely, but the agency is also struggling to keep addictive nicotine products out of the hands of middle and high school students. As a result, the FDA has denied all the menthol e-cigarette applications it has fully vetted to date. “An applicant must demonstrate that their flavored product provides an added benefit to adults in terms of complete switching or significant cigarette reduction, as compared to tobacco-flavored e-cigarettes, which have low appeal among youth,” Courtney Rhodes, an FDA spokesperson, said in a statement to POLITICO. Some public health experts worry the FDA has set impossible standards for menthol vapes. Documents obtained by POLITICO through the Freedom of Information Act showed that when Logic, an e-cigarette manufacturer owned by Japan Tobacco International, submitted data showing adult menthol smokers preferred menthol vapes over tobacco vapes, the FDA said it still wasn’t enough to authorize the products given the risk to youth. “If you set the bar that high, it’s a de-facto ban,” said a former senior FDA official granted anonymity to talk about the agency’s approach to tobacco regulation. Others argue that e-cigarettes are not a necessary smoking-cessation tool. Instead, the Biden administration must be prepared to offer existing resources — like nicotine-replacement therapies and counseling — more broadly, said Desmond Jenson, lead senior staff attorney for federal regulation and commercial tobacco control programs at the Public Health Law Center at the Mitchell Hamline School of Law. IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Your co-authors are excited about the start of the 2023 Women’s World Cup this week. Send news and tips to David Lim (dlim@politico.com or @davidalim or @david.a.lim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).   UNLEASH THE FUTURE OF HEALTHCARE WITH POLITICO, A 7/20 INTERACTIVE EVENT: Imagine a future where rare genetic diseases are not only treatable, but potentially curable. Where our approach to chronic illness takes a monumental leap forward. That future is already taking shape in the form of next-generation health care treatments such as gene therapy. Join POLITICO on Thursday, July 20 and delve into the burgeoning field of gene therapies, which hold the power to redefine our health care landscape. Are you ready to explore this new frontier in health care? Don't miss this chance to be part of the conversation. REGISTER NOW.     POLITICO is hosting a health care event, The Next Generation of Health Care Therapies, on Thursday starting at 4 p.m. ET. Join POLITICO to dive deep into the landscape of future health care treatments like gene therapy and how they could reshape our current health care system. TODAY ON OUR PULSE CHECK PODCAST, host Evan Peng talks with Ben Leonard, who breaks down CMS’ proposed changes to Medicare’s physician fees, which the agency says would advance lower costs and support behavioral health — and the ensuing praise and criticism that the plan has garnered. Listen to today’s Pulse Check podcast Eye on the FDA PROMISING ALZHEIMER’S DRUG DATA UNVEILED — Eli Lilly showcased data from its completed Phase III trial of donanemab at the Alzheimer’s Association International Conference in Amsterdam on Monday, Katherine reports. Over the course of the 18-month study, Alzheimer’s patients who received the drug showed a 22 percent to 29 percent slowing in cognitive decline, depending on the measure used, compared with patients who received a placebo. Lilly has already asked the FDA to grant donanemab traditional approval. It expects the agency to decide by the end of this year. If the agency agrees, it would be the second traditionally approved Alzheimer’s drug in 2023. A key to treating Alzheimer’s early is improving diagnostics, executives said. “Patients can receive the most benefit from donanemab when they are diagnosed and treated as early as possible,” said Mark Mintun, senior vice president of neuroscience research and development at Lilly, in a call with investors Monday. CMS proposed on Monday broadening Medicare coverage for amyloid PET scans, which is how most patients with Alzheimer’s are diagnosed. Currently, the agency covers just one amyloid PET scan for patients enrolled in a clinical trial. The agency proposes removing that criteria allowing Medicare Advantage Contractors to determine when the scans are appropriate. Amyloid is a protein thought to cause some of the cognitive decline associated with Alzheimer’s.   A message from 340B Health: 340B bridges the gaps in access to specialized services, providing support and ensuring equitable access to life-saving treatments. 340B helps pay for care for patients with diabetes, cancer, HIV/AIDS, opioid dependency, and mental illness, as well as those needing emergency trauma or burn care. 340B drug discounts – not taxpayer dollars – pay for this comprehensive care. Protecting 340B is crucial for the health of patients and communities. Learn more.   Until Monday’s FDA approval of Beyfortus, most infants had no protection against RSV. | AstraZeneca via AP Photo FIRST INFANT PROTECTION FOR RSV APPROVED — The FDA approved the first drug Monday designed to protect babies against respiratory syncytial virus during their first year of life, Katherine reports. RSV results in as many as 80,000 pediatric hospital visits annually and is especially dangerous for infants. Beyfortus, known as nirsevimab and developed by Sanofi and AstraZeneca, is a single injection of antibodies against the RSV virus. It is not a vaccine because it doesn’t cause the production of an immune response, but in late-stage clinical trials, it reduced the number of RSV-related doctors’ visits in infants by more than 70 percent. The FDA also approved Beyfortus for toddlers up to 24 months old to receive a second injection through their second RSV season if they are at risk of developing severe disease.   JOIN 7/27 FOR A TALK ON WOMEN LEADERS IN THE NEW WORKPLACE: In the wake of the pandemic, U.S. lawmakers saw a unique opportunity to address the current childcare system, which has become increasingly unaffordable for millions of Americans, but the initial proposals went nowhere. With the launch of the Congressional Bipartisan Affordable Childcare Caucus in May, there may be a path to make childcare more affordable in the U.S. Join Women Rule on July 27 to hear from featured speakers Rep. Ro Khanna (D-Calif.), Rep. Nancy Mace (R-S.C.) and Reshma Saujani, Founder & CEO of Moms First and Founder of Girls Who Code, on ways to reach a bipartisan solution on this timely issue for women in the workplace. REGISTER HERE.     In Congress SUBCOMMITTEE TO WEIGH DEVICE, DRUG COVERAGE  — The House Energy and Commerce Health Subcommittee meets this morning to hear from experts and trade lobbies on the Medicare coverage process for novel medical devices and drugs. Witnesses include Natalia Rost, the American Academy of Neurology’s president-elect; Thomas MacGillivray, president of the Society of Thoracic Surgeons; and Todd Brinton, advanced technology chief scientific officer at Edwards Lifesciences. Expect lawmakers to drill into CMS’ coverage policy for drugs that target amyloid brain protein for Alzheimer’s disease and the agency’s recent notice of a Transitional Coverage for Emerging Technologies pathway for breakthrough medical devices. The pathway aims to speed coverage of breakthrough devices. Around the Agencies FTC SUES TO BLOCK PHARMA AD DEAL — On Monday, the FTC sued to block healthcare data provider IQVIA’s deal for Propel Media, which owns advertising technology company DeepIntent, POLITICO’s Josh Sisco reports. The merger would give IQVIA, one of the largest pharmaceutical data and analytics companies, the leading position in the market for digital advertising of pharmaceuticals aimed at doctors, the FTC said. The agency said the acquisition would harm rivals and potentially increase costs for drugmakers. POLITICO first reported in May on the FTC’s investigation of the roughly $700 million merger and that the agency was leaning toward filing a lawsuit to block it. “We strongly believe in the benefits of the acquisition and will continue to pursue authorization to close the transaction as soon as we can,” IQVIA spokesperson Trent Brown said in an email to POLITICO.   A message from 340B Health:   What We're Reading Southern states are entering the third week of an extreme heat wave that is not abating, The Washington Post’s Matthew Cappucci reports. The FTC announced it is withdrawing two health care antitrust guidance documents, POLITICO’s Ben Leonard reports. Document Drawer The FDA warned consumers Monday not to use RoyalVibe Health, CellQuicken or Well-Being Reality ultrasound medical devices because they have not been reviewed by the agency. The Medical Device Manufacturers Association is scheduled to meet with the White House Office of Information and Regulatory Affairs today to discuss a final rule on hospital inpatient prospective payment systems for acute care hospitals.   A message from 340B Health: 340B hospitals are an essential part of the nation’s health care safety net, providing crucial services to patients with low incomes and those who live in rural America. Hospitals use 340B savings – not taxpayer dollars – to provide most of the nation’s unpaid and Medicaid hospital care, and they deliver vital services where access is limited. They help keep rural hospitals open for the patients and communities they serve. 340B lowers health care costs; supports doctors, nurses, and pharmacists; and expands care for patients – all without using any taxpayer dollars. Protecting 340B is the best way forward for patients and communities. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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