Photo of Amanda Bogle

Amanda Bogle

Subscribe to Amanda Bogle's Posts

Amanda Bogle is an associate in the Corporate Practice Group in the firm's Chicago office and a member of the Healthcare Team.

Contact:Read more about Amanda Bogle

A new chapter in the 340B Drug Pricing Program is unfolding as the Health Resources & Services Administration (“HRSA”) pursues its 340B Rebate Model Pilot Program (the “Pilot Program”)—a move signifying both innovation and the intensification of longstanding industry debate. After announcing the program in August, HRSA has since published several FAQs on the Pilot Program’s application process and operational considerations.[i] The comment period for the Pilot Program ended on September 8, 2025 and HRSA received over 1,200 comments from stakeholders.Continue Reading HRSA’s 340B Rebate Pilot Program: Industry Debates, Congressional Response, and Program Implications

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which participating drug manufacturers provide discounts to healthcare entities eligible to participate in the 340B Program.Continue Reading HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA encouraged health centers to “begin implementing these updated award terms immediately to ensure full compliance and maximize patient benefit.” The announcement comes in response to the Trump Administration’s April 14, 2025 Executive Order on “Lowering Drug Prices by Once Again Putting Americans First” (the “Executive Order”).[1] The Executive Order had instructed the Secretary of the Department of Health and Human Services to, within 90 days, ensure grants available under section 330(e) of the Public Health Services Act are conditioned upon health centers establishing practices to make insulin and injectable epinephrine available to low-income patients at or below the 340B price paid by the health center.Continue Reading HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug manufacturers must obtain pre-approval from HRSA before implementing rebate models under the 340B Program. Specifically, U.S. District Judge Friedrich (“Friedrich”) found that HHS and HRSA did not exceed their authority when they required Eli Lilly & Co., Bristol Myers Squibb Co., Sanofi-Aventis U.S. LLC, Novartis Pharmaceuticals Corp. (“Novartis”) and Kalderos Inc., a health care tech company (together, the “Companies”) to seek pre-approval of the rebate plans they offered.[i]Continue Reading Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March 10th, the FDA issued guidance clarifying that 503A and 503B drug compounders must soon cease compounding semaglutide injection products[i] or risk enforcement action.[ii] This has a significant impact on compounding pharmacies as, under the Federal Food, Drug, and Cosmetic Act (the “FD&C”), drug compounders are permitted to compound their own copies of a patented drug if the FDA determines it is in shortage. Due to high demand for the drugs, Wegovy was added to the FDA’s drug shortage list in March 2022, and Ozempic in August 2022.[iii] Wegovy and Ozempic are the only FDA-approved semaglutide injection products.[iv]Continue Reading FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

California is poised to pass a ballot measure aimed at imposing 340B spending restrictions for certain healthcare entities participating in the 340B Program who have historically engaged in spending that is not directly related to patient care and have also owned or operated multifamily dwellings with significant safety issues.Continue Reading California Votes to Impose 340B Spending Restrictions on Targeted 340B Providers