The 340B Drug Pricing Program: Administration, Litigation, and Reform

The 340B Drug Pricing Program is increasingly threatened by the Health Resources and Services Administration’s (HRSA’s) limited statutory authority and a wave of adverse litigation narrowing its ability to regulate and enforce program requirements. Drawing on recent court decisions involving orphan drugs, patient definitions, contract pharmacies, and administrative dispute resolutions in the 340B program, the authors contend that Congress must expand HRSA’s authority to ensure the program continues to function as intended.