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By: Baker & Hostetler LLP

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Latest from Health Law Update

Health Law Update

FDA Issues Guidance on Clinical Research with Cannabis

By Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton & Laura Macherelli
January 27, 2023
close up of a cannabis oil capsule composit image as a product concept

On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm…

Health Law Update

FDA Approves Abortion Pill for Sale by Retail Pharmacies

By Amy Fouts & Claire Bass
January 13, 2023

On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug…

Health Law Update

Discounted Drugs under the 340B Program

By Lee H. Rosebush, Laura Macherelli & Marc Wagner
December 20, 2022
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The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B program prohibits pharmaceutical manufacturers from imposing…

Health Law Update

Note of Caution to Compounding Pharmacies

By Lee H. Rosebush, Winston S. Kirton, Laura Macherelli & Marc Wagner
December 20, 2022
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Former co-owner of the now defunct New England Compounding Center (NECC) Gregory Conigliaro may face prison time for conspiring to defraud the U.S. Food and Drug Administration (FDA). Prosecutors argued Conigliaro conspired with more than a dozen others at NECC…

Health Law Update

Georgia 6-Week Abortion Law Is Void Ab Initio

By Amy Fouts & Claire Bass
November 18, 2022
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On Nov. 15, the Superior Court of Fulton County issued an order finding that two sections of the Georgia LIFE Act (the Act) – Sections 4 and 11 – were void ab initio. Section 4 of the Act criminalized abortions…

Health Law Update

Allergan Win in Medicaid Drug Rebate Statute

By Lee H. Rosebush, Stephen E. Ruscus & Laura Macherelli
October 21, 2022
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The United States Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC, a qui tam False Claims Act (FCA) suit, affirms the complexity of pricing and Medicaid rebates under the Medicaid Drug Rebate…

Health Law Update

Federal Judge Blocks Idaho from Enforcing Abortion Ban in Emergencies

By Amy Fouts, Gregory Tanner & Claire Bass
September 1, 2022
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On Aug. 24, the United States District Court for the District of Idaho issued a preliminary injunction blocking the enforcement of Idaho’s new abortion law. The law was set to take effect on Aug. 25, 2022. As previously reported,…

Health Law Update

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

By Justin Chavez & Vimala Devassy
August 8, 2022
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On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the Affordable Care Act (ACA). The aim of…

Health Law Update

DOJ Alleges Idaho Abortion Law Violates EMTALA

By Amy Fouts, Claire Bass & Gregory Tanner
August 4, 2022
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On Aug. 2, the U.S. Department of Justice (DOJ) filed suit against the state of Idaho to block a state abortion law set to take effect on Aug. 25, claiming that it violates the federal Emergency Medical Treatment and Labor…

Health Law Update

HHS and DOJ Issue Joint Guidance on Nondiscriminatory Telehealth Practices

By Vimala Devassy & Justin Chavez
August 3, 2022
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To coincide with the 32nd anniversary of the Americans with Disabilities Act (ADA), the Department of Health and Human Services Office for Civil Rights (OCR) and the Department of Justice’s Civil Rights Division (CRT) jointly issued Guidance on Nondiscrimination in…

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