Legal and Regulatory Landscape for Psychedelics as Therapies
Diagnosing Health Care Podcast
Release Date: 04/13/2023
Diagnosing Health Care Podcast
From removing diversity, equity, and inclusion initiatives to suspending foreign aid and canceling federal funding, it is clear that the current administration is drastically changing the landscape of government-funded research as we know it. What should research institutions be doing now to best prepare themselves for what's to come? On this episode, Epstein Becker Green attorneys , , and discuss how recent executive actions are impacting federally funded research at ambulatory medical centers, hospitals, universities, and other institutions, as well as how these actions may impact...
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Since Pam Bondi was appointed U.S. Attorney General, we’ve seen notable shifts in the U.S. Department of Justice’s (DOJ’s) criminal enforcement priorities. How significant are some of these changes, and how might they affect your health care organization as we progress through 2025 and beyond? On this episode, Epstein Becker Green attorneys , , , and discuss what to expect from criminal health care fraud enforcement under Attorney General Bondi’s leadership and how it may impact the health care industry. If you are interested in getting access to Epstein Becker Green’s...
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It is critical for health care and life sciences businesses to understand what might and might not change during this transitionary period. How can you advocate for your needs and priorities in a time of such uncertainty? On this episode, Epstein Becker Green (EBG) attorneys , , , and discuss the proposed leadership of the U.S. Department of Health and Human Services under the second Trump administration and the top-ticket items for these potential new leaders. This podcast was recorded on January 23, 2025. Since then, EBG has put out several important free resources in...
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The recent 2024 elections resulted in a new Trump administration and a Republican-controlled House and Senate. From policymakers to stakeholders across the industry, everyone is wondering what health policy will look like in 2025 and beyond. On this episode, Epstein Becker Green attorneys , , , and discuss the results of the 2024 elections and their impact on the health policy space. What will a second Trump administration look like? How might the election results affect the health care policies addressed during Congress’s 2024 lame-duck session? Visit our site for related resources and...
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One year ago, on October 30, 2023, President Joe Biden signed an executive order laying the groundwork both for how federal agencies should responsibly incorporate artificial intelligence (AI) within their workflows and how each agency should regulate the use of AI in the industries it oversees. What has happened in the past year, and how might things change in the next? On this episode, Epstein Becker Green attorneys , , and reflect on what is new in health care AI as a result of the 2023 executive order and discuss what industry stakeholders should be doing to comply and prepare for...
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Workplace violence in health care settings is on the rise, capturing the attention of both state and federal lawmakers. As awareness grows, so too does legal scrutiny and the push for new regulations and enforcement. In these seemingly critical times, what should health care employers be thinking about and incorporating into their comprehensive strategies to prevent and address workplace violence? On this episode, Epstein Becker Green attorneys , , and dissect the legal landscape surrounding health care workplace violence, examining the steps being taken at various levels of...
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The game has changed—are you positioned to adapt? Over the past 12 months, the federal government has been heavily regulating private investment in health care entities. Simultaneously, multiple states have enacted or introduced new laws restricting or requiring approval of such investments. The question arises: What do you do if you already have investments in these health care entities? On this episode, , Strategic Counsel at Epstein Becker Green (EBG), joins EBG attorneys , , and to discuss how health care entities, investors, and board members should be responding to an...
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Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to prevent penalties and protect themselves from DEA scrutiny? On this episode, Epstein Becker Green attorneys , , and discuss recent and pending updates to DEA rules and guidance, outline steps stakeholders can take to prepare for an inspection, and share tips on what to do when the DEA arrives. Visit our site for more information and related resources: Subscribe for...
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Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward? On this episode, Epstein Becker Green attorneys , , and lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds. Visit our site for more information and related resources: Subscribe for email...
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In a recent landmark decision, the U.S. Supreme Court overruled the Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo. This ruling has significant implications for employers and other entities in the health care and life sciences industries, as it changes the way courts are likely to interpret and apply regulations issued by federal agencies. On this episode, Epstein Becker Green attorneys , , , and analyze the fallout of this monumental decision, discuss what it means for entities seeking to challenge ambiguous statutes and regulations, and assess how to proceed...
info_outlineRenewed interest in the potential benefits of psychedelic treatments has led to an upsurge in research. Is the first FDA approval of a psychedelic for therapeutic use on the horizon? On this episode, Epstein Becker Green attorneys Delia Deschaine, Lisa Gora, and Jessika Tuazon examine the history of psychedelic substances in the United States and discuss the evolving legal and regulatory considerations impacting the development, approval, distribution, and use of psychedelic therapies in the United States.
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The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.