In this episode of the Diagnosing Health Care Podcast: The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization one year ago overturned 50 years of legal precedent protecting the constitutional right to abortion in the United States, leaving the question of whether and how to regulate abortion to individual states.
What has happened since and what is to come?
Epstein Becker Green attorneys Amy Dow, Erin Sutton, and Jessika Tuazon examine how the Dobbs decision has impacted the legal landscape for patient access to abortion, discuss the challenges facing the health care industry, and explore how industries can manage their compliance efforts moving forward as the legal landscape continues to evolve.
In this episode of the Diagnosing Health Care Podcast: On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone.
However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of mifepristone—and the U.S. Food and Drug Administration’s authority to approve new drugs—will continue to be debated on appeal.
On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester.[1] While this case addresses access to a single product and was prompted by abortion opponents’ efforts to eliminate access to medication abortion, a loss for FDA in this case could have far broader implications.
In this episode of the Diagnosing Health Care Podcast: In the aftermath of the Dobbs v. Jackson Women’s Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been used to induce abortions.
How can health care providers and pharmacies navigate these new restrictions?
On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]
The U.S. Supreme Court is expected to imminently issue its opinion in the case Dobbs v. Jackson Women’s Health Organization (“Dobbs”). If the Court rules in a manner to overturn Roe v. Wade, states will have discretion in determining how to regulate abortion services.[1] Such a ruling would overturn nearly 50 years of precedent, leaving patients, reproductive health providers, health plans, pharmacies, and may other stakeholders to navigate a host of uncharted legal issues. Specifically, stakeholders will likely need to untangle the web of cross-state legal issues that may emerge.
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Recent Updates
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- Indiana Senate Enrolled Act 9 Requires Written Notice of Health Care Entities’ Mergers or Acquisitions
- Connecticut Bill Calls for Office of Health Strategy to Develop a Plan Regarding Private Equity Firms in Health Care
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- FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines