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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Katherine Ellen Foley, Lauren Gardner and David Lim | | | | | 
FDA Commissioner Robert Califf says dialogue among experts is an important element at advisory committee meetings, which some say is lost in their online meetings. | Jim Watson/AFP via Getty Images | LOST IN (VIRTUAL) TRANSLATION? The FDA’s advisory committees, intended to supplement the agency’s drug and device approval process, went virtual at the start of the pandemic — and there’s no sign they’re going back. From today through the end of September, the FDA has scheduled seven meetings of its expert panels, none of which will be in person. Some experts fear that online discussions won’t be as robust — and therefore informative — as they could be. “The dynamic is diluted as a result of having a virtual meeting,” said Mark Senak, a regulatory lawyer who consults with pharmaceutical companies and follows FDA advisory committees. Remote meetings hide some cues from the panel members' tone, facial expressions and body language — and make it hard to interject without interrupting others. Joseph Daval, a postdoctoral research fellow at Harvard Medical School who studies FDA advisory committee trends, said remote meetings typically include more visual aids than there are at in-person meetings, which could bias the expert advisers. During public comment periods, meeting attendees can show more images of individuals living with diseases that lack treatments than they can in person. “Even if you’re skeptical of the evidence for the drug, how could that not sway your vote?” he asked. On the flip side, being remote isn’t all bad: Virtual meetings allow public health agencies to be more nimble, said Dr. Grace Lee, a professor of pediatrics at the Stanford University School of Medicine, who chairs the CDC’s vaccines advisory committee, which also remains remote. “It’s always nicer in person, but I do feel like because we had met so many times [over the pandemic], many of the technical challenges and logistical challenges just got easier over time,” she told Prescription Pulse. But there are downsides as the FDA works to reimagine independent advisory meetings. FDA Commissioner Robert Califf has said that recommendation votes at the meetings are far less important than the dialogue that occurs among experts. Dr. Namandjé Bumpus, FDA’s chief scientist, agrees. But the agency has yet to offer concrete reforms. “It’s important to get in the room with people when talking about these matters,” Dr. Caleb Alexander, internist and epidemiologist at Johns Hopkins School of Public Health who formerly served on the FDA’s neurological drug advisory committee, said. “It’s a significant price to pay for the convenience of dialing in on your phone.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. It may be recess on Capitol Hill, but for us, the regulatory news never stops. Send news and tips to Katherine Ellen Foley (kfoley@politico.com or @katherineefoley), Lauren Gardner (lgardner@politico.com or @Gardner_LM or @gardnerlm19) and David Lim (dlim@politico.com or @davidalim or @david.a.lim). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Daniel Payne, who explains why public health experts fear an uptick of opioid overdoses as pandemic protections expire and Medicaid unwinds, leaving millions of Americans with no health care coverage and potentially hobbling the nation's opioid response.
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Covid hospital cases are rising, but the Biden administration and health experts say the U.S. can manage the increases. | Brandon Bell/Getty Images | COVID HOSPITALIZATIONS UP — For the first time this year, Covid-19 hospitalizations are rising, but public health experts and the White House appear confident the U.S. is well positioned to manage the virus heading into the fall. The number of weekly hospitalizations rose 10.3 percent in mid-July to 7,109. But that’s still near an all-time pandemic low. “To some extent, I’m thinking of this as the new normal,” Scott Becker, CEO of the Association of Public Health Laboratories, said. “We never expected variants to just disappear, so the virus is doing what viruses do. We’re watching all of this in order to better be prepared for any fall surge in respiratory diseases.” Akin Demehin, senior director of quality and patient safety at the American Hospital Association, said Covid is not straining health care systems like it did during the pandemic’s first three years. “This likely reflects the fact that most individuals have at least some degree of immunity conferred from vaccination, prior Covid-19 infection, or both, along with the broad availability of treatments that significantly reduce the likelihood of needing an [emergency department] visit or hospital admission for Covid-19,” Demehin said. One challenge in the U.S. continues to be conveying that Covid is not an on-and-off switch, and there is tension between weighing the impact of the virus on one’s personal health and its impact on other people, according to Dr. Céline Gounder, an epidemiologist and infectious disease specialist and editor-at-large for public health at KFF Health News. “For the general healthy adult who is not elderly, who has been vaccinated, I think your risk of severe Covid is quite low,” Gounder said. “You may still get infected. That may be unpleasant, but the whole point of vaccination is to prevent you from landing in the hospital.”
| | | | YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today. | | | | | | | | | MEDICARE Rx PREMIUMS PROJECTED TO DROP — CMS said Monday it estimates the average monthly premium for Medicare Part D coverage to drop to $55.50 in 2024, a 1.8 percent decrease from this year. The agency attributed the price stability to “improvements to the Part D program in the Inflation Reduction Act that allow people with Medicare to benefit from reduced costs.” PHASE II TRIALS FOR LONG COVID TREATMENTS — The National Institutes of Health opened enrollment Monday for Phase II clinical trials of potential treatments for certain long Covid symptoms. The launch coincided with HHS’ announcement of the Office of Long COVID Research and Practice, which will spearhead federal long Covid response and coordination. One trial will target viral persistence by testing a longer regimen of Paxlovid than is currently used to treat acute infections. Another will test possible interventions, including web-based programs and an at-home medical device, for cognitive dysfunction symptoms such as brain fog and memory issues. CMS TO LAUNCH DEMENTIA CARE PROGRAM — The Biden administration will roll out a dementia care framework via Medicare over the next year, aiming to bolster support for patient caregivers and improve patient quality of life, Katherine reports. The Guiding an Improved Dementia Experience, or GUIDE, model — part of the National Plan to Address Alzheimer’s Disease — will focus on integrating services by giving participating families access to a 24/7 support line and an assigned point person to help navigate care options.
| | | WHO: TOBACCO CONTROL HAS IMPROVED — More than 70 percent of the global population lives in a country with at least one powerful measure of tobacco control, according to a new World Health Organization report published Monday. This is five times the number of people who lived in areas with at least one protective measure in 2007. The report, funded partly by Bloomberg Philanthropies, also found that 40 percent of countries have laws prohibiting smoking in public indoor spaces. | | Brianna Ehley Allen is a strategic communications adviser at the FDA’s Center for Devices and Radiological Health. She previously worked at FGS Global as a director of strategic communications for health and at POLITICO as a health policy reporter. Dr. Robert Steinbrook has joined Public Citizen as the director of the organization’s health research group. He was previously an editor-at-large at JAMA Internal Medicine. The National Pharmaceutical Council has hired Jon Campbell as chief science officer and Michael Pratt as chief communications officer.
| | | Emergent BioSolutions said Monday it has received a 10-year contract from the Biomedical Advanced Research and Development Authority worth up to $704 million for “advanced development, manufacturing scale-up and procurement of” Ebola treatment Ebanga.
| | | | HITTING YOUR INBOX AUGUST 14—CALIFORNIA CLIMATE: Climate change isn’t just about the weather. It's also about how we do business and create new policies, especially in California. So we have something cool for you: A brand-new California Climate newsletter. It's not just climate or science chat, it's your daily cheat sheet to understanding how the legislative landscape around climate change is shaking up industries across the Golden State. Cut through the jargon and get the latest developments in California as lawmakers and industry leaders adapt to the changing climate. Subscribe now to California Climate to keep up with the changes. | | | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
