| | | | |  | | By Krista Mahr and Daniel Payne | | | | | | | 
Democrats' loss of state Supreme Court races in both states could imperil the future of the procedure in both by cutting off a last line of defense against anti-abortion laws. | Michael A. McCoy/Getty Images | AN OVERLOOKED WIN FOR ANTI-ABORTION GROUPS — A pair of GOP victories on Tuesday threatens to undermine abortion access in Ohio and North Carolina, highlighting a bright spot for Republicans and anti-abortion groups amid an otherwise challenging election night, POLITICO's Megan Messerly reports . Democrats' loss of state Supreme Court races in both states could imperil the future of the procedure in both by cutting off a last line of defense against anti-abortion laws. The outcome : In Ohio, three anti-abortion, Republican Supreme Court candidates sailed to victory, likely dooming efforts to challenge state abortion restrictions. In North Carolina, two Republican wins give the court a conservative majority that could complicate Democratic Gov. Roy Cooper's efforts to preserve access. The Ohio results are particularly dispiriting for abortion-rights proponents as a law prohibiting the procedure after about six weeks of pregnancy — with no exceptions for rape or incest — works its way to the Ohio Supreme Court. In North Carolina, pro- and anti-abortion groups had zeroed in the state this year — which has become a haven for abortion access in the South — as Republicans gunned for a supermajority in the state legislature that would allow them to override vetoes from Cooper. While Republicans fell short of that, abortion-rights advocates are still concerned about the impact of conservatives picking up two seats on the high court and holding a 5-2 majority. The long game: With the fall of Roe v. Wade, the legal fight over abortion rights is poised to play out in state courts, where, in many instances, partisan judges will decide the future of access for millions of people. Abortion-rights advocates fared better in Kansas and Montana — two states where the issue could also soon come before their high courts. WELCOME TO FRIDAY PULSE — Today we're marking Veterans Day. Take a look at this new study being conducted by the CDC into whether veterans were exposed to cancer-causing toxins at an army base in California. Enjoy the weekend, and send those news and tips to kmahr@politico.com and dpayne@politico.com . TODAY ON OUR PULSE CHECK PODCAST — Sen. Bill Cassidy (R-La.), a gastroenterologist, is a contender to chair the Health, Education, Labor and Pensions Committee if Republicans can eke out control of the Senate. Ben Leonard talks with Alice Miranda Ollstein about his recent conversation with Cassidy, who is a telehealth proponent and has repeatedly warned about hackers targeting hospitals and other healthcare organizations. Plus, Lauren Gardner takes Pulse Check's 60 second challenge.
| | | | | | | A message from PhRMA: The 340B program may be driving up costs for some patients. A new analysis finds average costs per prescription for a patient is more than 150% greater at 340B hospitals than at non-340B hospitals. It's time to fix the 340B program. Learn more. | | | | | | WHY THE MIDTERM RESULTS ARE GOOD NEWS FOR FDA BILLS — FDA policies left off the September user fee reauthorization are likely to be included in an end-of-year government funding bill after Democrats emerged stronger than expected from the midterm election, POLITICO's David Lim and Lauren Gardner report. Though final results are still to come, the narrow margin for control of both chambers is leaving little room for the "four corners" user fee agreement reached in September to fall apart again. The leaders of the Senate HELP Committee and House Energy and Commerce Committee have pledged to return to the negotiating table ahead of the Dec. 16 government funding deadline to hash out the policies left behind in September's user free authorization deal, such as provisions to tweak the FDA's accelerated approval pathway and bolster clinical trial diversity. TACKLING THE YOUTH MENTAL HEALTH CRISIS — The Substance Abuse and Mental Health Services Administration (SAMHSA) released a new report on Thursday, saying that improvements to crisis response services for children and families are urgently needed. Citing significant gaps in capacity to help children and families across the country, the National Guidelines for Child and Youth Behavioral Health Crisis Care offers "a framework that states and localities across America can consider as they develop or expand their crisis safety net for youth and families," the report says.
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The TRIPS Waiver was met with resistance from major pharmaceutical companies that said it would threaten investment and innovation. | WHO KILLED THE TRIPS WAIVER? Early in the pandemic, India and South Africa had a radical idea: allow some intellectual property rights for Covid-19 products to be waived during the pandemic, give companies wanting to produce vaccines and treatments the freedom to operate, and make both more widely available to humanity. But the proposal – known as the TRIPS Waiver — was met with resistance from major pharmaceutical companies that said it would threaten investment and innovation. And rich nations, including EU members and the U.K., resisted it, arguing it wouldn't help bridge the gaps in vaccine availability between wealthy and poorer nations. Reporting by our colleagues in POLITICO Europe and the Bureau of Investigative Journalism chronicles how the TRIPS Waiver proposal was stymied and watered down by negotiators, until it was finally signed off by governments desperate to save a flagging project. Pharma firms used their vast lobbying and influencing efforts to try to kill a proposal that threatened the very tenets of the industry. Top industry executives enjoyed direct access to senior officials within the EU, which was opposed to the proposal from the very start and encouraged potentially rogue member countries, including Italy and France, to fall into line. And the U.S., after a dramatic late intervention in favor of a waiver for vaccines, eight months after the proposal had been tabled, failed to follow through as the Biden administration came under pressure from industry and Congress, as reported by the Intercept. INFANTS AND COVID HOSPITALIZATION — A CDC study published on Thursday found that hospitalization rates of infants under six months with Covid-19 increased as Omicron became the dominant variant, though their cases were not more severe. Babies in that age group, who are not eligible for vaccination, are also more likely to be hospitalized with Covid-19 than older children, teenagers, and adults under 65, the study found. Researchers wrote the increase was likely due to "the high infectivity and community transmission" of the Omicron variant and "the relatively low threshold for hospitalizing infants for signs and symptoms consistent with COVID-19 relative to that in older children." The CDC has urged pregnant people to get vaccinated to protect themselves and their infants from the virus.
| | | | A message from PhRMA:   | | | | | | PUBLIC HEALTH EMERGENCY WATCH — There is no expectation that the Biden administration will issue a 60-day notice before Saturday that the Covid-19 public health emergency will end, a senior administration official told POLITICO's Adam Cancryn. PROVIDERS PUSH CONGRESS, HHS TO EXTEND PANDEMIC RULES ON TESTOSTERONE — Gender-affirming care providers are lobbying to ensure they can continue to prescribe testosterone virtually after the pandemic ends, POLITICO's Ben Leonard reports. In 2020, in response to the Covid-19 pandemic, the Drug Enforcement Administration and HHS' Substance Abuse and Mental Health Services Administration waived provisions of a 2008 law that required doctors to meet with a patient in-person before prescribing controlled substances. Those rules expire when HHS ends the Covid-19 public health emergency that now runs till mid-January. Plume, a Denver-based provider, has paid Washington firm Mehlman Castagnetti Rosen & Thomas $260,000 since September 2021 to lobby Congress and HHS to extend the eased pandemic rules allowing patients to receive controlled substances without first going to an in-person doctor's visit. FOLX Health, a Boston-based provider, is also pushing for extending the pandemic rules.
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The latest National Youth Tobacco Survey found nearly 2.6 million teens used e-cigarettes | AP Photo/Richard Vogel | TOBACCO STILL DRAWING KIDS IN — More than 3 million middle and high school students have used a tobacco product in the past month, according to a new survey from the Centers for Disease Control and Prevention and the Food and Drug Administration, POLITICO's Katherine Ellen Foley reports. The National Youth Tobacco Survey, published Thursday, found nearly 2.6 million teens used e-cigarettes, making them the most popular products for the ninth year in a row. Cigars followed with 500,000 routine users, cigarettes with 440,000 users, smokeless tobacco with 330,000 users, hookah with 290,000 users, nicotine pouches with 280,000 users, heated tobacco products with 260,000 and pipe tobacco with 150,000 users. In total? That's roughly 11.3 percent of American minors, including 16.5 percent of high school students and 4.5 percent of middle school students. HHS ANNOUNCED CLIMATE PLAN AT COP27 — The U.S. Department of Health and Human Services unveiled a new pledge from more than 100 health organizations committing to significantly reduce greenhouse gas emissions in the coming years. The organizations, including hospitals, pharmacies, clinics, insurers and suppliers, pledged to cut emissions by 50 percent by 2030 — and reach net zero emissions by 2050. The efforts, from the Office of Climate Change and Health Equity, come after the agency has worked to increase its efforts addressing both climate and health. And HHS is teaming up with the U.K.'s National Health Service to reduce the environmental impacts of the health sector, they announced at the conference. At COP27 (the Conference of Parties of the United Nations Framework Convention on Climate Change), the groups agreed to reduce emissions from health supply chains. The groups will work to create procurement standards aiming to lessen the health sector's environmental impact in both countries. Meetings to begin that work will continue through next year with the goal of presenting more at COP28.
| | | | STAY AHEAD OF THE CURVE: Our Future Pulse newsletter will continue to bring you the biggest stories at the intersection of technology and healthcare, but now five times a week. Want to know what's next in health care? Sign up for our Future Pulse newsletter. If you aren't already subscribed, follow this link to start receiving Future Pulse . | | | | | | | | Vanity Fair investigates how a decades-old legal decision has prevented active-duty service members from suing the federal government for wrongful injury or death outside of combat. AstraZeneca has dropped plans to get its Covid-19 approved by the FDA, The Wall Street Journal reports . In Boston, mask mandates in schools were associated with dramatically reduced numbers of Covid-19 cases, according to a new study written about in The New York Times .
| | | | A message from PhRMA: The 340B program grew, yet again, hitting a whopping $43.9 billion in sales at the discounted 340B price in 2021. But there has not been evidence of corresponding growth in care provided to vulnerable patients at 340B covered entities. And making matters worse, fresh data show that 340B may actually be driving up costs for some patients and our health care system as whole. The program of today is having the opposite effect of what Congress intended when they created 340B. That's a problem. It's time to fix the 340B program. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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