|
Presented by 340B Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Katherine Ellen Foley and Lauren Gardner | Presented by 340B Health | PROGRAMMING NOTE: We’ll be off this Tuesday for Indigenous Peoples Day but will be back in your inboxes on Wednesday. With Chelsea Cirruzzo
| | |  FDA Commissioner Robert Califf says one of the biggest issues the FDA faces is the spread of misinformation. | Jose Luis Magana/AP Photo | CALIFF: FIGHTING THE MISINFO ‘HYDRA’ — FDA Commissioner Robert Califf said Thursday that misinformation, what he sees as one of the biggest issues facing his agency’s many jurisdictions, needs an equally expansive, overlapping approach. In a press conference, Califf referred to misinformation as a “hydra,” comparing it to the beast that grows multiple new heads when one is cut off. He fingered inaccurate information as a major cause of the stagnation of U.S. life expectancy, which decreased to an average of 76.4 years in 2021 from 77 the year prior, according to the CDC. “This is not just about vaccines, and I want to be really clear about that … it’s about tobacco, it’s about food, it’s about taking generic medicines that are effective instead of ineffective treatments,” Califf said. His remarks were in response to a report by the nonprofit Reagan-Udall Foundation, which he’d asked to study how health professionals and consumers perceive information about FDA-regulated products. The report called on the FDA to make communications an equal pillar to science and policy in its mission and to develop ways to make its messages more digestible for the public. It recommended the agency take a proactive approach to communicating about its work — and the evolving nature of science — instead of “chasing misunderstanding” later. Califf said it would be impossible for his agency alone to correct misinformation. “The whole public health sector and educational sector need to be activated and involved,” he said. One barrier to total transparency from the agency is confidential business information, Califf said. “We have information by law that we can’t reveal,” he said. “We often know about a decision we’re going to make … but it’s illegal for us to reveal that decision until the moment we do it because many of those decisions affect stock prices.” Talk to us: “We have a whole thing in government called the Paperwork Reduction Act that keeps us from interacting with people,” Califf said, pointing to the fact that the agency speaks mostly with patient and consumer groups instead of directly responding to individual consumers. The law requires that agencies work with the White House’s Office of Management and Budget before directly asking for public feedback. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Speaking of misinformation — the FDA wants to know where you get your medical information. Drop them a line, and let us know how you think the agency could improve public trust. 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, your host Katherine talks with POLITICO New York health care reporter Maya Kaufman, who reports on the increase of tuberculosis cases in New York City — on track to reach the city's highest levels in more than a decade — and the possible implications of the spike.
| | | | A message from 340B Health: 340B hospitals put their patients first by serving as a vital safety net for essential health care. 340B hospitals provide 77% of the nation’s Medicaid care and 67% of unpaid hospital care. Protecting 340B is crucial for the health of patients and communities. Learn more. | | | | | | | | | | 
An FDA panel of outside experts recommended against approving Amgen's non-small cell lung cancer drug. | AP Photo | ADVISERS SKEPTICAL OF AMGEN CANCER DRUG — The FDA’s oncology advisory committee voted 10-2 Thursday against the idea that Amgen’s non-small-cell lung cancer drug Lumakras improved survival without further disease progression based on a late-stage clinical trial. The drug was granted accelerated approval in 2021. Amgen then asked the agency to grant it conditional approval based on an additional trial, but FDA scientists raised concerns about the number of patients who dropped out during the study and the drug’s potentially dangerous side effects. The negative vote came down to the specificity of the FDA’s proposed language, Dr. Edward Cliff, an oncology fellow and research fellow at Harvard Medical School who attended the meeting, told Prescription Pulse. “They didn’t ask if there was a net clinical benefit — they asked how reliable is this [endpoint] in the context of all these concerns,” he said. The agency might not pull Lumakras from the market, Cliff, who studies regulatory decisions, said. It could maintain the drug’s accelerated approval status until additional data from ongoing clinical trials is ready. The agency is slated to make a final decision by Dec. 24. It doesn't have to side with its advisory committee, but it often does. ADVISERS RECOMMEND FUTURE FLU SHOT CHANGE — The FDA’s external vaccine advisers voted unanimously Thursday to recommend excluding a lineage of influenza B strain from four-strain flu shots as soon as possible, challenging drugmakers and the FDA to consider such a move by the next flu season. The experts’ advice comes because the B/Yamagata lineage has gone undetected worldwide since March 2020, suggesting it’s no longer a significant public health threat. Quadrivalent flu vaccines first became available in the U.S. in 2012 after manufacturers added a second distinct B strain to their historically three-strain formulations, with the goal of broadening protection. All currently distributed flu vaccines in the U.S. cover four strains, though the manufacturers were all previously licensed to produce trivalent shots. The committee acknowledged there could be regulatory and manufacturing challenges in reverting to trivalent shots in other countries but pointed to the recommendation’s open-ended timeline. The panel also unanimously voted to recommend compositions for the Southern Hemisphere’s 2024 trivalent and quadrivalent formulations.
| | | | 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. | | | | | | | | | OLDER ADULTS HIT HARDEST BY RSV — Most hospitalizations for respiratory syncytial virus among older Americans between last summer and this summer were for people ages 75 and older, according to a CDC report published Thursday. Nearly a fifth of those adults lived in long-term care facilities. According to the agency’s RSV surveillance system, the number of RSV cases nationwide has ticked upward as this year’s season gets underway. This is the first year an RSV vaccine is available and recommended for adults at least 60 years old.
| | | | A message from 340B Health:   | | | | | SCOTUS CASES COULD REMAKE HEALTH POLICY — The most important health care cases headed to the Supreme Court this term seemingly have nothing to do with health care. Regulations covering small fishing vessels and financial fraud are the subjects of some cases that are part of a broader conservative effort to rein in the administrative state. The outcomes could set precedents that might block the FDA from expanding abortion pill access and the CDC from implementing pandemic safeguards, among other health policies, Lauren and POLITICO’s Alice Miranda Ollstein write. Marc Scheineson, a former FDA associate commissioner under then-President George H.W. Bush and is a partner at Alston & Bird, told POLITICO agencies need the authority to clarify laws through their rulemaking powers, given how vaguely Congress can write statutes. Gutting that authority, he said, could turn scientists away from government service — not to mention roil the pharmaceutical industry. “For drug companies, it’s hard enough to find a blockbuster drug and cure an intractable disease,” Scheineson said. “But who’s going to invest in these companies if they don’t even know, if they prove it to be safe and effective, that it will remain on the market?” The conservative groups behind the efforts argue that health policy is one of many areas where the federal government has overreached. “This is business as usual when it comes to holding federal agencies accountable for failing to follow the law,” said Erik Baptist, a senior counsel for Alliance Defending Freedom, who is leading several challenges to federal agency powers, including FDA regulation of mifepristone.
| | | | 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. | | | | | | | | Alimera Sciences, an ophthalmic pharmaceutical company, announced Jason Werner as chief operating officer and Philip Ashman as president of international operations. Linsey Marr, a Virginia Tech engineering professor known for her aerosols expertise during the pandemic, has been named a 2023 MacArthur Fellow.
| | Mobile health clinics at Dollar Generals could close some health care gaps in rural America, Sarah Jane Tribble reports for KFF Health News. Tuberculosis cases in New York City are on the rise, and health centers may not be prepared to treat them, POLITICO’s Maya Kaufman reports.
| | The FDA published draft guidance Wednesday for drug manufacturers developing treatments for stimulant use disorder.
| | | | 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 use savings from drug discounts to provide most of the nation’s unpaid and Medicaid hospital care, and they deliver vital services where access is often limited in rural communities. 340B savings enable hospitals to stay open for the patients and communities they serve. 340B lowers health care costs; supports doctors, nurses, and pharmacists; and expands care for the benefit of patients – all without using any taxpayer dollars. Protecting 340B is the best way forward for patients and communities. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
