In recent weeks, two competing visions have emerged to legislatively modernize the federal 340B drug discount program (“340B Program”). On July 6, 2026, Representatives Scott Peters (D-CA) and Dr. John Joyce (R-PA) introduced the bipartisan House bill H.R. 9599, called the SECURE 340B Act (or “the 340B House Bill”), hailed as “the first-ever comprehensive, bipartisan proposal to modernize the 340B Drug Pricing Program since its creation in 1992.” This follows on the heels of the Senate bill “340B Drug Pricing Integrity and Affordability for Patients Act” that was issued as a discussion draft (“340B Senate Discussion Draft”), released by Sen. Bill Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee, on June 25, 2026. Cassidy’s 340B Senate Discussion Draft was touted as the first statutory update to the 340B Program in fifteen years.
The Food and Drug Administration (FDA) issued a draft guidance (Draft Guidance) on July 11, 2016 that allows some generic drug manufacturers holding an Abbreviated New Drug Application (ANDA) to update the label of the drug they manufacture with new safety information. The Draft Guidance provides new clarifications and recommendations to generic drug manufacturers seeking to update a generic label after withdrawal by the name brand manufacturer of the reference listed drug (RLD) (a "Withdrawn RLD"). The Draft Guidance explains how a generic manufacturer may submit an updated ...
Recent Updates
- What CMS's 2027 Fee Schedule Changes Mean for Shared Savings Program ACOs
- CMS Wants to End Certain COVID Requirements, Natural Light in Patient Care Areas: Proposed Rule Would Update CoPs for Hospitals, LTC Facilities, and Other Providers
- The Structural Pressures Behind Senior Living and Long-Term Care Distress
- CMS Proposed Rule to Implement Section 6224 of the Consolidated Appropriations Act
- FDA Finalizes Key Parts of Its NDIN Guidance Related to Identity and Safety Information: What Dietary Supplement Companies Should Know