AMERICAN UNIVERSITY | WASHINGTON COLLEGE OF LAW
Health Law & Policy Brief
The Health Law & Policy Brief is an online publication run by law students at American University Washington College of Law. Founded in 2007, the Health Law & Policy Brief publishes articles on a wide array of cutting-edge topics in health law. Such topics include health care compliance, fraud and abuse enforcement, health insurance payment and reimbursement issues, intellectual property issues, international human rights issues, FDA initiatives and policies, and a host of other matters. Beginning with a staff of just five, the Health Law & Policy Brief now boasts over thirty staffers and nearly 1,500 readers.
Current Issue
Volume 20, Issue 2
The Next Layer of Oversight:
State Expansion of Healthcare Transaction Review Laws
Esther Braha, J.D., Emma Pons Claramunt, Esq., & Ari J. Markenson, J.D., M.P.H.
Latest from the Blog
Understanding The Structural Barriers to Redefining GRAS
In August 2026, the Food and Drug Administration proposed a new rule to strengthen regulation of substances added to food that are classified as Generally Recognized as Safe (GRAS). A substance is GRAS if qualified experts generally recognize its safety under its intended conditions of use, based on scientific evidence or common use in food before 1958. Since 1958, manufacturers have been able to determine GRAS status […]
Mifepristone Preemption Discussion by Fourth Circuit
On October 28, 2026, a U.S. Court of Appeals panel heard arguments from Republican lawmakers in Richmond, Virginia, to limit state access in North Carolina. This new law, if passed, would ensure that mifepristone could only be prescribed via an in-person visit and would require a similar follow-up appointment. Mifepristone, the “abortion pill,” […]
Are we Ready for AI to Take Over our Prescriptions?
Pharmacists play an essential role in managing patients’ healthcare needs. Their job requires precision, organization, and specialized knowledge to ensure patients receive the correct medications in the proper doses and are sufficiently instructed on how to administer them. Although essential, many aspects of this job can be tedious and time-consuming, prompting researchers to explore ways to […]
Pregnancy Exclusions in Advance Directives
In 2013, Marlise Munoz collapsed while getting up to make a bottle for her son, and her husband rushed her to John Peter Smith Hospital in Fort Worth, Texas. Two days after doctors discovered a blood clot in her lungs, Marlise was declared brain dead. The hospital was unable to remove her ventilator because […]
Largest Health Care Fraud Scheme Uncovered by the Department of Justice
On October 22, 2023, the Department of Justice announced that it would be prosecuting its largest substance abuse treatment fraud scheme ever. Fifteen defendants, including individuals from Los Angeles, Texas, and Illinois, face charges for $2 billion in fraudulent government claims. The claims include “sham substance abuse treatment programs, unnecessary artery treatments, and […]
PhRMA’s Challenge to the GLOBE Model
The Centers for Medicare & Medicaid Services (CMS) finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) Model on September 30, 2026. The final rule was published in the Federal Register on October 2 and takes effect on November 30, 2026. GLOBE offers an alternative way to calculate manufacturer rebates under Medicare Part B’s Drug Inflation Rebate […]
Contingency Management: An Effective Framework for Treating Stimulant Use Disorder and Opportunities for State Medicaid Coverage
Between 2003 and 2022, drug overdose deaths in the United States drastically increased by 366%. The major culprit for the increase in narcotic-related mortality were opioids, a class of drugs including heroin, fentanyl, and oxycodone. In recent years, because of more effective treatment options and the availability of opioid overdose-reversal […]
The Judiciary Jabs Back at RFK Jr.’s Changes to the Childhood Vaccine Schedule
On March 16, 2026, U.S. District Court Judge Brian E. Murphy granted an injunction preventing HHS from revising the childhood immunization schedule and staying the appointments of thirteen members of the CDC Advisory Committee on Immunization Practices (ACIP). A legal challenge to these changes to the vaccine schedule seemed all […]
Continued Uncertainty in Title X Funding for Family Planning Services
The Title X Family Planning Program has been a major part of reproductive health care in the United States for over 50 years. It was established in 1970 when Congress passed the Public Service Act, and it remains the only federal program focused entirely on family planning and preventative health […]
Ethical Considerations in Plasma Donations Across the United States
For the past twelve years, William Jacques has visited CSL Plasma twice a week to donate his plasma. He brings in $460 a month, likening it to a part-time job. He’s not the only one. Across the United States, Americans are consistently frequenting plasma donation centers in exchange for a […]