Biden’s new medical device

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

Jun 30, 2023 View in browser   By David Lim and Katherine Ellen Foley With Ben Leonard Programming note: We’ll be off this Tuesday for the Fourth of July but will be back in your inboxes on Wednesday. Driving the day President Joe Biden recently began using a continuous positive airway pressure machine for sleep apnea. | Evan Vucci/AP Photo BIDEN BOOSTS SLEEP APNEA AWARENESS — President Joe Biden in recent weeks began using a continuous positive airway pressure machine to get better sleep, joining millions of Americans that use the medical devices to manage sleep apnea. Bloomberg White House reporters asked about it after seeing indentations on the president’s face from use of the machine. “Since 2008, the President has disclosed his history with sleep apnea in thorough medical reports,” White House spokesperson Andrew Bates said in an email. “He used a CPAP machine ... which is common for people with that history.” What is sleep apnea? The common condition of obstructive sleep apnea is estimated to affect about 30 million U.S. adults. It causes people to frequently stop breathing during sleep, causing them to wake up. Those with sleep apnea can suffer from tiredness during the day. What is a CPAP machine? Medical devices such as CPAP machines provide patients a supply of pressurized air through a mask that helps the airway remain open during sleep. The medical device is prescribed by a doctor, typically after a sleep test, so that a device can be properly fitted. The FDA angle: Biden’s use of the medical devices comes amid efforts by Philips Respironics to remediate a substantial 2021 recall of certain ventilators, bilevel positive airway pressure and CPAP machines at risk of having polyester-based polyurethane sound abatement foam break down. Since April 2021, the FDA received 385 reports of deaths in medical device reports reportedly associated with suspected foam breakdown. As of May 31, Philips Respironics reports about 2.4 million devices have been remediated and sent back to durable medical equipment providers and patients. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Have a safe and happy Fourth of July. Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Daniel Payne about his chat with CDC Rochelle Walensky, whose last day at the agency is today. They spoke about what's next for the future of the CDC and her successor. Listen to today’s Pulse Check podcast Tobacco THE END OF A TOBACCO-CONTROL ERA — After 23 years, Matthew Myers’ last day as the leader of the nonprofit Campaign for Tobacco-Free Kids is today. “It's a really good time,” Myers told Prescription Pulse. “We have the potential in the next 12 to 24 months of truly making cigarette smoking among our nation's kids a matter of our history, not our future.” Myers is a well-known figure in the world of tobacco-control efforts. He started at CTFK in 1996 as the organization’s first executive vice president and legal counsel, before becoming president in 2000. During his tenure, the national youth smoking rate plummeted to under 3 percent from about 35 percent in 1998, according to the CDC. He hopes the FDA’s forthcoming ban on menthol cigarettes will continue to lower that figure. But youth e-cigarette use remains a problem. In 2022, a federal survey found that 2.6 million middle and high school students regularly used e-cigarettes — a number that has fallen from a peak of more than 5 million in 2019. “The biggest challenge we face is to maintain momentum and energy,” Myers said. Even among tobacco-control advocates, Myers has his critics. “The way that he addressed issues involving vaping regulation and the great tension between the desire to protect kids and the need to serve the health needs of adult smokers … has been to the detriment of the [FDA’s] overall public health mission,” said Cliff Douglas, director of the University of Michigan's Tobacco Research Network. What’s next: Myers plans to retire, but will stay on as an adviser to CTFK. Yolonda Richardson, CTFK’s executive vice president for global programs, will take over to lead the organization. In Congress House lawmakers are working to reach agreement on a deal to reauthorize the Pandemic and All-Hazards Preparedness Act. | Francis Chung/POLITICO E&C PLANS PAHPA MARKUP — The House Energy and Commerce Health Subcommittee plans to mark up legislation to reauthorize the Pandemic and All-Hazards Preparedness Act on July 13, according to a tentative committee schedule obtained by POLITICO and five lobbyists with knowledge of the plans. Last week, Rep Anna Eshoo (Calif.), the Democrats’ lead negotiator, met with Chair Cathy McMorris Rodgers, chief GOP negotiator Rep. Richard Hudson (N.C.) and Rep. Brett Guthrie (R-Ky.), who leads the health subcommittee, to work on an agreement, according to three of the lobbyists granted anonymity to discuss the negotiations. No deal was reached, but talks between Eshoo and Hudson continue as Republicans expect to move ahead with a markup, the three lobbyists said. Democrats are still trying to persuade the GOP majority to include provisions to tackle drug shortages in the must-pass package or ensure the issue is otherwise addressed.   SUBSCRIBE TO POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY.     At the Agencies CDC ENDORSES RSV VACCINE — The CDC recommended on Thursday that adults 60 and older receive a respiratory syncytial virus vaccine, provided their physicians agree it is appropriate for them. The FDA approved RSV vaccines from GSK and Pfizer earlier this year, and the agency’s endorsement follows the recommendation its advisers made last week. Eye on the FDA FIRST DONOR PANCREATIC CELL THERAPY APPROVED — The FDA has approved the first therapy for type 1 diabetes using deceased donor pancreatic islet cells. Lantidra from CellTrans involves one to three infusions and in clinical trials meant some patients could discontinue regular insulin injections for more than a year. CellTrans did not immediately respond to inquiry regarding the cost of the treatment. Industry Intel GSK ACQUIRES CHRONIC COUGH PORTFOLIO — GSK has completed its acquisition of Bellus Health, a company developing a drug to treat refractory chronic cough in late-stage clinical trials. Pharma Moves Sarah Emond, executive vice president and COO of the Institute for Clinical and Economic Review, has become the nonprofit drug pricing watchdog group’s president-elect. Steve Pearson, the group’s current president, plans to step down at the end of the year but will continue to serve as an adviser. What We're Reading Global health researchers are asking the NIH to revise its proposed policy that would require foreign subrecipients of NIH grants to provide in-depth copies of their research notes, Erin Schumaker reports for POLITICO. FDA Commissioner Robert Califf proposed an overhaul of the agency’s Office of Regulatory Affairs, which plays a major role in food inspections, Meredith Lee reports for POLITICO. Despite the FDA’s denial of millions of e-cigarette marketing orders, U.S. sales data show new types of vapes have tripled since 2020, Matthew Perrone writes for The Associated Press. Document Drawer The FDA scheduled a two-day meeting to discuss clinical study disruptions during public health emergencies for Oct. 18-19. The FDA published draft guidance on how the agency will interpret laws prohibiting the wholesaling of drugs from compounding pharmacies. The FDA published draft guidance on how manufacturers should present efficacy and risk data on over-the-counter drug labels and advertisements.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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