FDA Issues Guidance on Clinical Research with Cannabis

CBD oil 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 Bill, which legalized the production and sale of hemp (cannabis below 0.3 percent delta-9 THC by dry weight) and removed it from the Schedule I substance list.

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FDA Approves Abortion Pill for Sale by Retail Pharmacies

Pharmacist and customer discussing prescription in pharmacy

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 mifepristone requesting modification of the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program.

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Discounted Drugs under the 340B Program

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 restrictions on how their drugs are distributed.

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Note of Caution to Compounding Pharmacies

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 to deceive and defraud the FDA by misrepresenting the facility as solely a compounding pharmacy dispensing only patient-specific prescriptions while in fact it was also operating as a generic drug manufacturer.

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Georgia 6-Week Abortion Law Is Void Ab Initio

Pregnant woman talking a break while working in Roastery

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 after the detection of a heartbeat (typically around six weeks into the pregnancy), with exceptions only for certain medical emergencies and in cases of rape or incest where a police report was filed. Section 11 required any physician who performed an abortion after detecting a fetal heartbeat to report to the Georgia Department of Public Health the exception under Section 4 of the Act that applied to justify the otherwise illegal procedure. Spokespersons for the state reported that the state has filed a notice of appeal.

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Allergan Win in Medicaid Drug Rebate Statute

RX pharmacy prescription bottle of pills on a pile of $100 dollar bills and a USA outline Medicaid Drug Rebate

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 Statute, emphasizes the need for government guidance in complex regulations, and further confirms the importance of documenting intentions and reasonable assumptions with respect to the Rebate Statute. The Court was evenly split in upholding the dismissal of the suit brought by a former employee alleging Forest Laboratories LLC committed Medicaid fraud by violating the Medicaid Drug Rebate Statute and unjustly profiting from it.

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Federal Judge Blocks Idaho from Enforcing Abortion Ban in Emergencies

Modern Hospital Building

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, the U.S. Department of Justice (DOJ) filed suit on Aug. 2 against the state of Idaho, seeking to block the recently passed state abortion law. The DOJ alleged the Idaho law violates the federal Emergency Medical Treatment and Labor Act of 1986 (EMTALA) because it does not provide any exceptions for stabilizing treatment in emergency medical situations.

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

diverse group of people

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 Section 1557 is to ensure access to health care and coverage in certain health programs or activities. The Proposed Rule aims to realign the scope of Section 1557 — which has been subject to several regulatory changes, interpretations and litigation throughout several presidential administrations — with the underlying statutory and regulatory intent, after the 2020 Final Rule regarding Section 1557 was limited in its reach following challenges to the regulation in litigation.

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DOJ Alleges Idaho Abortion Law Violates EMTALA

emergency room emtala

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 Act of 1986 (EMTALA).

Under EMTALA, a hospital that receives Medicare funds must provide treatment to patients who present to the hospital’s emergency department with an “emergency medical condition.” The DOJ explains that “emergency medical conditions” under EMTALA “include not just conditions that present risks to life but also those that place a patient’s ‘health’ in ‘serious jeopardy’ or risk ‘serious impairment to bodily functions’ or ‘serious dysfunction of any bodily organ or part.’”

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HHS and DOJ Issue Joint Guidance on Nondiscriminatory Telehealth Practices

father daughter cell phone telehealth

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 Telehealth: Federal Protections to Ensure Accessibility to People with Disabilities and Limited English Proficient Persons (Guidance) on July 29, 2022, as part of their continued commitment to ensuring that telehealth is accessible in a nondiscriminatory manner.

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