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Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | |  | | By Krista Mahr and Sarah Owermohle | | | With help from Megan Wilson Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro.
| | | — Senators advanced the must-pass user fee reauthorization package; a timeline for next steps is still to come. — FDA advisers recommend authorizing Moderna’s Covid-19 vaccine for kids 6 to 17, but it's unclear whether parents will seek out the shots. — The AMA adopts new policies on firearm violence, physician burnout and reproductive health in a wide-ranging annual meeting. WELCOME TO WEDNESDAY PULSE — Sorry, Happy the Elephant. You may deserve our compassion, but a person you’re not. Send news and tips to kmahr@politico.com and sowermohle@poltico.com.
| | | | A message from PhRMA: Did you know that only three insurance company pharmacy benefit managers (PBMs) control 80% of patients’ medicines? They decide what medicines are covered, what medicines aren’t and what you pay for them, regardless of what your doctor prescribed. Meanwhile, they get tens of billions in rebates and discounts meant for you. PBMs are putting their profits before your medicine. Tell Congress savings belong to patients. | | | | 
Sen. Patty Murray gives an opening statement during a Senate Appropriations Subcommittee hearing. | Greg Nash/Getty Images | HELP COMMITTEE ADVANCES UFA — The Senate HELP Committee advanced its Food and Drug Administration user fee reauthorization package on Tuesday, POLITICO’s Katherine Ellen Foley and David Lim report. The bill — considered to be must-pass legislation — was amended to include provisions aimed at preventing future baby formula shortages, among other issues. Chair Patty Murray (D-Wash.) told POLITICO that the Senate intends to make sure the amendments make it into the final bill. They aren’t present in the bill’s House version, which passed on the floor in a 392-28 suspension vote last week. The package would enable the FDA to collect fees from manufacturers of brand drugs, generic drugs, biosimilars and medical devices for another five years. In exchange, the agency pledges to hire additional review staff and expeditiously review product applications. The current five-year FDA user fee agreement expires at the end of September. What’s next: Murray declined to lay out a specific timeline for next steps for the user fee package, saying she plans to work with Senate Majority Leader Chuck Schumer (D-N.Y.) on floor timing. FDA ADVISERS RECOMMEND MODERNA VACCINE — The Food and Drug Administration’s advisers voted unanimously on Tuesday to recommend authorizing Moderna’s Covid-19 vaccine for kids ages 6- to17 years, POLITICO’s Lauren Gardner reports. The move brings American families one step closer to having more choices for vaccinating children. The group of independent advisers agreed that the benefit of increasing those options outweighed any risk the vaccine poses to children in the two age groups, 12- to 17-year-olds and 6- to 11-year-olds. The FDA said in a briefing document published last week that the shot was generally safe and effective in both groups. Up next: Today, the committee will consider Moderna’s vaccine for children ages 6 months through 5 years, which would be a 25-microgram dose, alongside Pfizer-BioNTech’s bid to vaccinate kids under 5. It’s all broadly good news. But: It’s unclear whether any of it will do much to increase the number of American adolescents and kids who are vaccinated against Covid. As of April 30, just 29 percent of U.S. children ages 5 to 11 were fully vaccinated, compared with nearly 56 percent of 12- to 15-year-olds and 67 percent of 16- and 17-year-olds, according to the CDC.
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The AMA is worried about practitioner burnout. | AP Photo | DOCTORS’ GROUP TALKS GUNS, BURNOUT AND ABORTION — At its annual meeting this week, the American Medical Association adopted a new firearm violence policy focused on children’s mental health and gun safety, as well as physician burnout. The gun policy says schools should use “evidence-based and trauma-informed” approaches to train kids how to respond to active shooters in a way that minimizes unintended effects on mental health. The AMA said it will research improved methods to prepare children for a tragic possibility without traumatizing them. The group also calls on state and federal lawmakers to draft bills targeting so-called ghost guns, or homemade firearms, and advance legislation that would require warning labels on ammunition packaging. The burnout guidance urges states to create “safe haven” health programs that would help doctors seek burnout counseling and treatment; current programs focus more on physical wellness than on mental health. AMA also reiterated longtime opposition to restraints on reproductive health, which has taken fresh urgency with the specter of Roe v. Wade’s potential overturning. Its updated policy adds a plan for AMA to seek legal protections for patients who cross state lines to access reproductive health services.
| | | SENATE PANEL UNVEILS YOUTH MENTAL HEALTH PLAN — The Senate Finance Committee this morning released adiscussion draft focused on bolstering mental health care services for kids and teens. The proposal focuses on barriers in Medicaid that slow down reimbursements and services. It would compel states to clarify Medicaid guidance on allowable payments, improve screening and diagnostic benefits and order Medicaid to issue guidance on care for foster youth with mental health care needs. The Medicaid program “covers half of all children in this country,” Committee Chair Ron Wyden (D-Ore.) noted. He and co-sponsors ranking member Mike Crapo (R-Idaho), Sen. Tom Carper(D-Del.) and Sen. Bill Cassidy (R-La.) also pointed to a surge in mental health needs during the pandemic. HOUSE APPROPRIATORS UNVEIL FDA FUNDING BILL — House Democrats’ fiscal 2023 spending measure would bump the FDA’s budget by 10 percent to $3.6 billion next year. The baby formula crisis is a reminder of how critical the Agriculture-FDA funding bill is “to the health and safety of children and families,” House Appropriations Chair Rosa DeLauro (D-Conn.) said. The measure would create “a more resilient baby formula market,” she said, by boosting funding for FDA workers who do inspections and review new products. DeLauro introduced the $28 million emergency spending bill to bolster FDA staffing to address the formula shortage last month. The bill stalled in the Senate after House passage last month, POLITICO’s Jennifer Scholtes notes. What’s next: The subcommittee plans to mark up the Agriculture-FDA funding bill this afternoon, with full committee consideration next week. The bill could go to the House floor in July.
| | | U.S. ABORTIONS RISE BETWEEN 2017 and 2020 — A survey released today shows that the number of abortions in the U.S. jumped 8 percent between 2017 and 2020 — the first documented increase after more than three decades of declining demand, POLITICO’s Alice Miranda Ollstein reports. The survey, completed in May and released today by the Guttmacher Institute, an abortion-rights think tank, found that 930,160 abortions were performed nationwide in 2020, up from 862,320 in 2017. Researchers attribute the increase to several factors, including the pandemic, changes to the Title X family planning program and expanded health insurance coverage of the procedure. While more than two dozen states implemented restrictions on abortion between 2017 and 2020, many of those efforts were blocked by courts. And because those states already had limited access to the procedure, the report’s authors posit that those new laws had a smaller impact than those in the states that expanded access to abortion.
| | | IS MONKEYPOX A GLOBAL EMERGENCY? The World Health Organization is convening its emergency committee next week to decide whether the monkeypox outbreak is a public health emergency of international concern — the world’s highest health alert. The meeting should help international coordination on the response now that monkeypox has spread to at least 39 countries (including seven where it’s endemic), which have in total reported more than 1,600 confirmed cases, 1,500 suspected cases and 72 deaths to the WHO, our Carmen Paun and Daniel Payne report. “It’s now clear that there is an unusual situation, meaning [that] even the virus is behaving unusually from how it used to behave in the past,” WHO Director-General Tedros Adhanom Ghebreyesus told reporters Tuesday. CANADA RELAXES MANDATES — Following months of pressure, the government of Prime Minister Justin Trudeau said it would relax Canada’s domestic vaccine travel mandates, POLITICO’s Andy Blatchford reports. Unvaccinated Canadians will be able to fly domestically and overseas and travel by train as of June 20. Vaccine mandates will remain in place for cruise ships. Incoming foreigners must still be vaccinated against Covid-19 to enter the country, and unvaccinated Canadians must continue to adhere to quarantine guidelines upon arrival.
| | | Erik Rasmussen, the longtime top lobbyist for the American Hospital Association, has started a new lobbying firm, Meridian Government Affairs. The firm will focus on funding for hospital, Medicare and Medicaid policy, he told Megan.
| | | The FDA clears software that enables your Apple Watch to track Parkinson’s symptoms, STAT News reports. There is an underwhelming body of evidence that supplements can boost your mood and reduce your anxiety, The New York Times writes. The Washington Post reports on Japan’s abortion laws, some of the strictest among the world’s wealthy nations. Kaiser Health News reports that while preventive screening may be free, the out-of-pocket costs for follow-up tests can be hundreds or thousands of dollars. (Thousands, in my own recent experience.)
| | | | A message from PhRMA: This may come as a shock, but did you know that only three insurance companies and their pharmacy benefit managers (PBMs) control 80% of patients’ medicines? They sure act like it. They use their market power to get tens of billions in rebates and discounts on medicines – rebates and discounts that should be going to patients. They decide what medicines are covered, what medicines aren’t and what you pay for them. Regardless of what your doctor prescribed. That’s too much control, and it leaves you fighting them for your medications, instead of fighting your illness. PBMs are putting their profits before your medicine. It’s time we do better than that for patients. Tell Congress those savings belong to patients. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
