| | | | |  | | By Lauren Gardner, Katherine Ellen Foley and David Lim | Presented by 340B Health | | | | | | 
As the FDA's chief scientist, Namandjé Bumpus has been put in charge of regulating cosmetics and other personal care products. | Michael A. McCoy/The New York Times via Redux Pictures | MORE THAN A COSMETIC CHANGE — FDA Chief Scientist Namandjé Bumpus is leading the agency’s work implementing new regulatory authority for cosmetics — the first overhaul of U.S. cosmetics regulation since the 1930s. Those closely following the FDA’s new powers have praised the decision by Commissioner Robert Califf to put Bumpus in charge, given her office’s focus on science and stature within the agency. Now comes the hard part — following Congress’ direction with limited resources. Bumpus, who had chaired the pharmacology department at the Johns Hopkins University School of Medicine, said the agency is working with the money available to meet the Dec. 29 deadlines for product and facility registration and to later publish rules on good manufacturing practices and fragrance allergens. Having the authority to order mandatory product recalls will strengthen the FDA’s ability to protect public health, she said. What’s to come: In the coming years, the FDA will issue rules setting mandatory standardized testing methods for detecting asbestos in talc-containing products. Scott Faber, senior vice president for government affairs at the Environmental Working Group, said his organization looks at the talc rules as “the first test of FDA’s commitment to protecting consumers and fulfilling the intent of Congress.” Money woes: Industry is advocating for the FDA to receive more funding to carry out the new law as lawmakers run up against a Nov. 17 deadline to keep the federal government running. A shutdown “could be a fly in the ointment and complicate things” for the new cosmetics rules, said Tom Myers, the Personal Care Products Council’s head of legal and regulatory affairs. You can read more on what Bumpus told Lauren in her Q&A about the FDA’s work to understand an industry making everything from cleansers to baby wipes. IT’S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re sending healing vibes to Illinois Democrat and vocal tobacco foe Dick Durbin, who had his knee replaced this week “as a result of [his] unremarkable high school football career.” Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with Kaja Klapsa, a former POLITICO fellow and a reporter for the German newspaper Die WELT, who explores what's behind the gender-affirming care in Europe that many Republicans point to when advocating for restricting such care for minors in the U.S. — and explains how the view on the other side of the Atlantic is more nuanced than portrayed.
| | | | | | | A message from 340B Health: 340B hospitals serve as a vital safety net for essential health care. 340B hospitals provide 77% of all hospital care to Medicaid patients and 67% of all unpaid hospital care in the U.S. Protecting 340B is crucial for the health of patients and communities. Learn more. | | | | | | | 
Pharmacists at Walgreens and CVS have been walking off the job to protest a lack of staffing and other resources. | Ben Margot/AP | ABOUT THOSE CHAIN PHARMACY WALKOUTS — CVS and now Walgreens have seen pharmacy staff stage walkouts at some locations nationwide in the past few weeks. Both companies say they’re listening to the concerns from staff and acknowledge it’s a busy time of year, with seasonal vaccines and illnesses demanding more attention from pharmacists and pharmacy technicians. Prescription Pulse talked to American Pharmacists Association CEO Michael Hogue about the root issues at play. Here are his thoughts on four factors behind the walkouts: Staffing, compensation shortfalls: The pandemic spurred a sharp increase in job vacancies for pharmacy technicians, with 25,000 to 30,000 open positions in the U.S., Hogue said. Pharmacy technicians are typically responsible for prescription intake and counting, preparing and labeling medications. “The problem with that is that, whether it’s chain drugstores or hospitals or any component of the pharmaceutical supply chain … the pay scale for pharmacy technicians is terribly low,” he said, with techs making minimum wage in some states. Demanding times: Pharmacists are charged with ensuring the safe and effective use of medicines, Hogue said, but they need time to focus on drug and drug-disease interactions to do so. With the dawn of Covid-19 and respiratory syncytial virus vaccines and tests, he said, they’re now asked to do more preventive health consultations. “They’re capable of it … but those things all take time, and with the lack of staffing, it creates quite a pressure,” Hogue said. Performance metrics: Some pharmacy chains have performance metrics for their stores, focusing on the number of prescriptions dispensed and vaccines given, Hogue said. Those benchmarks don’t account for the time it takes pharmacists to do patient safety work, he said, which has frustrated staff. While Walgreens has stopped using those metrics, Hogue said, pharmacists at the local level say district-level managers are still enforcing them. APhA and the National Alliance of State Pharmacy Associations have called on employers to endorse a “responsibilities and rights” document for pharmacists, emphasizing quality of care in any performance evaluation of pharmacy staff. Adversarial customers: Patient behavior toward pharmacists and technicians has “gotten exponentially worse” since the pandemic, Hogue said. What were once occasional outbursts have “become a daily thing now, a regular occurrence.” The chains respond: “We’re focused on developing a sustainable, scalable action plan that can be put in place in markets where support may be needed so we can continue delivering the high-quality care our patients depend on,” said CVS spokesperson Amy Thibault. “We are committed to ensuring that our entire pharmacy team has the support and resources necessary to continue to provide the best care to our patients while taking care of their own well-being,” Walgreens spokesperson Kris Lathan said. “We are making significant investments in pharmacist wages and hiring bonuses to attract/retain talent.”
| | | | DOWNLOAD THE POLITICO APP: Stay in the know with the POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need. DOWNLOAD FOR iOS – DOWNLOAD FOR ANDROID. | | | | | | | | | ADVAMED LAUNCHES DIGITAL HEALTH GROUP — The largest medical device lobby this week launched a division focused on digital health technology. Called AdvaMed Digital Health Tech, the division will focus policy lobbying on cybersecurity, data stewardship and privacy, payment and health care delivery and regulation. The group's board is composed of representatives from companies, including GE HealthCare, Johnson & Johnson, Stryker, Medtronic, Apple, Google, Microsoft and Amazon. Shaye Mandle has been appointed the division’s executive director. He was CEO of the Medical Alley Association and COO of the Biotechnology Innovation Organization.
| | WARNING AGAINST AT-HOME KETAMINE PRODUCTS — Ketamine formulas mixed at compound pharmacies or at home, or prescribed by telehealth, may pose a serious risk for patients using it to treat mental health conditions, the FDA alerted Monday. The FDA noted that only one ketamine therapy has been approved for treatment-resistant depression, and it is administered under health care supervision. The agency hasn’t approved the anesthetic drug for other mental health conditions or for use at home, and there is not yet data suggesting it is safer or more effective than existing treatments. Those who take other forms of ketamine at home are at risk for dangerous blood pressure spikes, respiratory depression and psychiatric events, the FDA warned, citing an instance where a person using home ketamine therapy was found to have twice the amount in their blood as is used for anesthesia.
| | | | A message from 340B Health:   | | | | | POSITIVE EARLY RESULTS FOR WEGOVY IN KIDNEY TRIAL — Danish drugmaker Novo Nordisk said Monday it would end its randomized trial studying the efficacy of the weight-loss drug Wegovy to prevent the progression of kidney disease in patients with type 2 diabetes. An interim analysis showed that the drug was successfully meeting its endpoints, and the company expects a full readout of the data in 2024.
| | MORE COOLING AGENTS IN NONMENTHOL CIGS — Nearly half of cigarettes boasting their ability to skirt recent state menthol bans in California and Massachusetts produce a greater cooling effect, according to a research letter published in JAMA on Monday. State bans on flavored tobacco, including menthol cigarettes, aim to get smokers to quit. Substitutions for menthol in cigarettes might stop some smokers from quitting, the authors warned, concluding that “regulators should consider including synthetic coolants in flavor bans because they can mimic menthol’s actions.”
| | | | A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY. | | | | | | | | | Drugs like Ozempic have weight-loss empires like Weight Watchers changing their tune, Erich Schwartzel writes for The Wall Street Journal.
| | The FDA released final guidance on how companies should test whether medical devices are safe and compatible in an MRI environment and convey safety information in labeling. The FDA also issued final guidance on what information should be included in a premarket application for magnetic resonance diagnostic devices.
| | | | A message from 340B Health: 340B hospitals are the backbone of the nation’s health care safety net, providing essential services to patients with low incomes and those living in rural America. 340B hospitals provide most of the nation’s unpaid and Medicaid hospital care, and 340B savings allow them to continue their commitment to mission. 340B savings enable hospitals to stay open, maintaining access to care for the patients and communities they serve. 340B lowers health care costs, and enables doctors, nurses, and pharmacists to provide expanded care for the benefit of their community– all at no cost to the taxpayer. Protecting 340B is the best way to advance the health of patients and communities without burdening taxpayers. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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