| | | | | | | Presented By PhRMA | | | | Axios Vitals | | By Tina Reed · Apr 13, 2023 | | 👋 Welcome to Thursday, Vitals readers. Today's newsletter is 1,085 words, a 4-minute read. Situational awareness: The Department of Justice is requesting a stay to the ruling which struck down the Affordable Care Act's preventative care requirements. Here's a look at the judge in the case. | | | | | | 1 big thing: Federal appeals court partially blocks Texas abortion pill ruling |  | | | Illustration: Gabriella Turrisi/Axios | | | | A federal appeals court late Wednesday partially blocked a Texas judge's decision halting the FDA's approval of the widely used abortion pill mifepristone, Axios' Oriana González reports. The big picture: The 2-1 ruling by a three-judge panel on the conservative-leaning court means that, for now, mifepristone is still available in the U.S., but with several strict limitations. Details: The New Orleans-based 5th U.S. Circuit Court of Appeals granted the Biden administration's request to put on hold part of the Texas judge's order blocking the FDA's approval of the pill, pending the outcome of the lawsuit challenging the FDA on this authority, which has been in place since 2000. - However, changes the FDA made in 2016 lifting certain restrictions on mifepristone are now suspended under the appeals court ruling. That restores a requirement that patients need the supervision of a qualified physician to obtain the pill.
- The judges also suspended the FDA's 2021 approval for the pills to be sent by mail, as well as its approval of a generic version.
Catch up quick: U.S. District Court Judge Matthew Kacsmaryk last week stayed the FDA's approval of mifepristone, in a widely criticized decision that used anti-abortion rhetoric to argue that medication abortion has a "negative impact" and that the agency's safety data on the pill is "potentially misleading." - The Justice Department quickly appealed, calling Kacsmaryk's order "extraordinary and unprecedented."
- The Texas judge, the DOJ argued, "upended decades of reliance by blocking the FDA's approval of mifepristone ... based on the court's own misguided assessment of the drug's safety."
- Mifepristone is part of a two-drug regimen used in medication abortion, which now accounts for 53% of abortions in the U.S., according to the Guttmacher Institute, a research organization that supports abortion rights.
What's next: The Biden administration and the drug's manufacturer could appeal to the Supreme Court to have the lower court's ruling fully overturned. Related: Biden to strengthen privacy laws to shield patients seeking abortion pills |     | | | | | | 2. GOP frustrations with the FDA build |  | | | Illustration: Aïda Amer/Axios | | | | Republican frustrations with the FDA have been building for a long time, potentially raising the stakes in the legal battle over its approval of a widely used abortion pill, Axios' Maya Goldman, Victoria Knight and Peter Sullivan write. Why it matters: The frustration underscores the difficult choices facing the agency, which is also being pressed by progressives to ignore the court. Driving the news: A group of 69 Senate and House Republicans on Tuesday asked the 5th U.S. Circuit Court of Appeals not to stay the ruling, charging that "[t]he FDA's unlawful approval and deregulation of chemical abortion drugs subverts Congress' public policy considerations and safeguards for patient safety." The big picture: The battle over the drug mifepristone ruling comes after a tough stretch for the FDA: Controversy around the infant formula shortage, fast-tracked approval of Alzheimer's drugs and the COVID-19 vaccine has riled up GOP lawmakers. - Democrats, sensing the political upper hand, have been more vocal than Republicans in the wake of the abortion pill ruling. But 67 congressional Republicans also signed an amicus brief in February that supported the lawsuit in which the Texas judge banned the use of mifepristone.
What's next: One former GOP staffer said Rep. Andy Harris, the Maryland Republican who chairs the subcommittee that handles FDA appropriations, won't hesitate to cut the agency's funding if he feels it's being political. (Harris' office did not respond to a request for comment. The congressman has not released a statement on the Texas ruling.) - "I don't think it would be to defund the entire FDA because I think most people are cognizant that FDA has a valuable important role to play," the former staffer said.
- "But if they want to be political … well fine, then there's going to be consequences."
A version of this story was published first on Axios Pro. Get news like this by subscribing. Use code POLICY100 which gives you $100 off. | | | | | | | | 3. $2M gene therapies for sickle cell deemed cost effective | | A $2 million gene therapy for sickle cell disease could be cost-effective in some instances, though there's still uncertainty about long-term health risks, according to a draft report from the Institute for Clinical and Economic Review, Axios' Adriel Bettelheim reports. Why it matters: Multimillion-dollar gene therapies are becoming more commonplace, offering hope to patients with debilitating conditions but bringing huge cost challenges, as Axios' Caitlin Owens has written. Go deeper: The ICER study looked at two experimental treatments: bluebird's lovo-cel and Vertex and CRISPR's exa-cel, neither of which has been priced. - Using a placeholder price of $2 million for each therapy, ICER found both are likely to substantially improve quality and length of life.
- The study pegged the total economic burden of sickle cell disease at $2.98 billion a year in the U.S., with 57% due to inpatient costs.
- Stem cell transplantation is currently the only treatment that can deliver a potential cure, but donors can be hard to find and risks increase with age.
Of note: Young Black patients account for most hospitalizations for sickle cell disease, and ICER notes it's been historically underfunded with no breakthroughs or developments in two decades. | | | | | | | | A message from PhRMA | | What's a pharmacy benefit manager (PBM)? | | |  | | | | They decide if medicines get covered and what people pay for them, regardless of what your doctor prescribes. These middlemen are putting their profits before your wellness. And getting between you and your doctor. You need to see what's going on. | | | | | | 4. Data du jour: Suicide rates rise after decline |  Data: CDC; Note: Standard populations are the age distributions used as weights to create age-adjusted statistics; Chart: Axios visuals After a two-year decline, the U.S. suicide rate increased again in 2021, making it the 11th leading cause of death, data from the CDC's National Center for Health Statistics released today show. The big picture: The suicide rate increased by 4% from 2020 to 2021, reaching a rate of 14.1 deaths per 100,000 people. That's up from 10.7% in 2001. Zoom in: Although rates were lowest for females ages 10 to 14, that group experienced the largest percentage increase over the past two decades, from 0.6 deaths per 100,000 people in 2001 to 2.3 in 2021. Experts have expressed growing concern over the mental health of teens, particularly adolescent girls. ● Among young males, the most significant increase in suicide rates occurred from 2020 to 2021 for those ages 15–24, from 22.4 per 100,000 people to 23.8. If you or someone you know may be considering suicide, contact the National Suicide Prevention Lifeline at 988 (En español: 1-888-628-9454; Deaf and Hard of Hearing: dial 711 then 1-800-273-8255) or the Crisis Text Line by texting HOME to 741741. | | | | | | | | 5. Catch up quick | | 💰 Juul to pay $462 million to six U.S. states, and D.C. over youth addiction claims. (Reuters) 🏛 A federal judge presses Texas to better monitor residential foster care facilities after reports of medical mismanagement. (Texas Tribune) 🔬 A game-changing new Parkinson's test paves the way for treatments and a cure. (Forbes) | | | | | | | | A message from PhRMA | | Insurers and PBMs don't pay full price for your medicines. So why do you? | | |  | | | | Insurers and pharmacy benefit managers (PBMs) get discounts on medicines. Surprised? These savings can reduce the cost of some brand medicines by 50% or more, but insurers and PBMs aren't required to share these savings with you. See what else they don't want you to know. | | | | Thanks for reading, and thanks to senior health care editor Adriel Bettelheim and copy editor Azi Najafi for the edits. |  | | Dive deeper into the future of health care | | | | | | Axios thanks our partners for supporting our newsletters.
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