Ted Slafsky’s Post

Louisiana's governor on May 24 signed a bill making his state the first in the U.S. to classify two abortion-inducing medications as controlled substances, a category that healthcare regulators typically reserve for drugs prone to abuse or addiction. The new law designates mifepristone and misoprostol, which the FDA approved more than two decades ago as safe and effective for terminating pregnancies, as Schedule IV drugs, typically pain-killers and mood-altering medications that merit greater oversight due to their potential for abuse or dependence. The measure, thrusting Republican-led efforts to restrict abortion back to the political forefront in a presidential election year, was signed into law by Republican Governor Jeff Landry a day after the state legislature sent it to his desk. The bill cleared Louisiana's Republican-majority House of Representatives and Senate by wide margins, even as efforts by the U.S. Food and Drug Administration to expand access to abortion pills is facing a legal challenge before the Supreme Court. Find out more: https://reut.rs/4bw0w1t 

Quick keynotes in the Supreme Court’s unanimous decision in #FDA v. Alliance for Hippocratic Medicine that “holds that the plaintiffs lack a legal right to challenge the FDA's actions regarding the regulation of mifepristone, the drug used in medication abortion.” ·      "Under Article III of the Constitution, a plaintiff's desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs' other standing theories suffice… FDA is not requiring them to do or refrain from doing anything." ·      "Given the broad and comprehensive conscience protections guaranteed by federal law, the plaintiffs have not shown--and cannot show--that FDA's actions will cause them to suffer any conscience injury." ·      However, looking ahead, the Court avers that "is not clear that no one else would have standing to challenge FDA's relaxed regulation of mifepristone." First and foremost, kudos to the Administration and the FDA for the successful defense against what could have been an existential threat to our legal foundation for life science #innovation. The innovative and #patient communities’ voices were also well represented in amicus briefs. But no resting on laurels: because the decision rests on standing and not on the critical issues raised by this case, it is a brief respite – from a surprisingly unified Court – and does nothing to foreclose future, similar judicial threats to FDA’s authority and to #abortionaccess. Opinion is here: https://lnkd.in/eHAQNy2W #kendallsquarepolicy 

FDA has been tasked by Congress with ensuring the safety and effectiveness of our #medicalproduct supply for decades. In fact, in the shadows of the thalidomide disaster of the 1960s the U.S. showed great leadership and wrote the global standards for demonstrating a drug's safety and effectiveness. In the decades since, #FDA's experts have continued to lead the way on the most complicated #regulatory issues from #raredisease #drugdevelopment to #patientfocuseddrugdevelopment, #genetherapies, #precisionmedicine, the use of #artificialintelligence in #medicalproducts, and so much more - and through #ICH, other efforts for global or regional harmonization, and many other mechanisms the agency's experts continue to set the standard on new frontiers in regulatory policy. It is reassuring to see this scientific and regulatory leadership unanimously reaffirmed by the Supreme Court today!

On March 26, the US Supreme Court is hearing oral arguments in a case that could dramatically reshape the abortion access landscape—again. Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA) is a groundless lawsuit targeting mifepristone, one of two drugs used in the most common abortion method in the US. Let’s be clear: Access to mifepristone is unchanged for now until the Court issues a decision. As our analysis explains, SCOTUS’s only reasonable option in this case is maintaining full access to this critical drug. Whether you've been following the case since the beginning or it’s new to you, our latest analysis breaks down the 8 key points you need to know. 📢 https://gu.tt/49Jw5E0

Join us for a rally at the United States Supreme Court to stand for women’s health and safety! WHAT IS THIS CASE ABOUT? The FDA betrayed women when it removed the in-person doctor visits and ongoing care it originally deemed necessary for the use of abortion drugs. On March 26, the Supreme Court is considering whether to require the FDA to honor its duty to protect women’s health and reinstate its safety standards. WHAT’S AT STAKE? Whether the FDA will protect women's health and safety. WHAT IS YOUR ROLE? You can stand with women harmed by the FDA's actions and hold it accountable for leaving women to have abortions alone without the care of their doctor. Signs will be provided at the rally. WHEN Tuesday, March 26, 2024 8 AM – 12 PM WHERE The Steps of the United States Supreme Court 1 First Street NE, Washington, D.C. 20543 QUESTIONS? info@putwomenfirst.com Further Reading: AAPLOG Committee Opinion 9: Dangers of Relaxed Restrictions on Mifepristone: https://buff.ly/3X6JAq7 #WOMENSHEALTHMATTERS

As medical professionals, it is our duty to educate the legal community on the intricacies of emergency abortion and the complications that arise when clinical care is denied to patients. Recently, the potential reversal of Roe V Wade has brought this issue to the forefront. That's why I voluntarily presented our new scoring system to help non-medical professionals make informed decisions when it comes to providing or denying care. Our goal is to clear the clutter and ensure that patients receive the care they need. https://lnkd.in/dx4rKF5k

Thank you to Iowa Pharmacy Association for inviting Boesen & Snow founding partner, Mark Boesen, J.D., Pharm.D., to give a keynote presentation at the annual convention. In his presentation titled, "How Did My Tuesday Change? The Direct Effect Policymakers and the Courts Have on Your Day-to-Day Professional Life", Mark discussed how changing just one law can alter the everyday life of a pharmacist. Pharmacists need their voices to be heard, and one of the best ways to make this happen is getting involved in politics. While many pharmacists like Vice President Hubert Humphrey, Representative Buddy Carter, and Representative Diana Harshbarger have had successful political careers, getting involved politically does not mean becoming a politician, but it does show the importance of using your voice to make change. Pharmacists can and should be involved by joining their pharmacy associations, meeting and writing representatives, understanding court decisions that affect pharmacists, and supporting pharmacy-friendly candidates and causes. As abortion laws and other healthcare issues arise, pharmacists must have a seat at the table to be a voice for the profession and those they serve. We want to hear from you: How have you seen pharmacists effectively amplify their voices in policymaking to ensure their profession's concerns are heard and addressed amidst evolving healthcare laws and regulations?

Louisiana lawmakers have voted to pass legislation to classify mifepristone and misoprostol, two FDA-approved drugs used for medication abortion, as schedule IV drugs. This first-in-the-nation legislation is unconscionable and dangerous, and more than 200 doctors in LA have come forward to state that it will "delay access to care and worsen outcomes." This legislation will build on the current near-total abortion ban and will have resounding harmful impacts on patients, their families, and health care providers. #bansoff https://lnkd.in/eTzmRM5d

Today, after extensive briefing and oral argument in April, the U.S. Supreme Court declined to review 𝑀𝑜𝑦𝑙𝑒 𝑣. 𝑈𝑛𝑖𝑡𝑒𝑑 𝑆𝑡𝑎𝑡𝑒𝑠, which posed whether federal law requires hospital emergency rooms, in delivering emergency healthcare, must also offer emergency abortion access to pregnant patients in appropriate circumstances, regardless of state law: https://lnkd.in/eYH8J6bt   The decision today leaves that question open, and the lower court's order permitting emergency abortions in Idaho remains intact for now while litigation continues. Our view, however, hasn't changed. In an emergency room, any patient would naturally expect prompt, stabilizing medical care. Federal law requires no less, and it is no different for pregnant patients in emergencies where the stakes are high. In an amicus brief to SCOTUS with nearly 100 organizations, NAPABA argued what we believe federal law makes plain: pregnant patients are entitled to meaningful access to emergency healthcare, including emergency abortion access. Read our brief here: https://t.co/JAQ28AxzRj

Today, the U.S. Supreme Court hears the FDA challenge of a lower court ruling that it must reinstate the guidelines placed on the chemical abortion drug mifepristone when it was first approved in 2000. Since then, the FDA has rolled back several of these safeguards, such as the requirement for in-person dispensation of mifepristone by the prescriber, which has opened the door for dangerous mail-order abortions with no medical supervision. This case is crucial for the safety of our patients. -The American Association of Pro-Life Ob/Gyns (AAPLOG) #aaplog #allianceforhippocraticmedicine #aaplogfdalawsuit #aaplogchemicalabortion #aaplogscientificscholarship #aaplogmedicalevidence #joinaaplogtoday