HRSA Delays Effective Date of 340B Final Rule...Again

The final rule set forth guidance regarding the calculation of 340B ceiling prices for both new and established drugs made available through the 340B Program, and the imposition of civil monetary penalties on drug manufacturers who knowingly and intentionally charge covered entities prices that exceed the applicable 340B ceiling price. Arent Fox’s Health Care Counsel blog previously covered and analyzed the release of the final rule and its impact on manufacturers and covered entities alike.

Fiday’s notice announced that HRSA will delay the effective date of the final rule until October 1, 2017 “to provide affected parties sufficient time to make needed changes to facilitate compliance” and “to mitigate implementation concerns.” This announcement represents the third time this year that HRSA has pushed the effective date of the final rule – and could be interpreted as recognition of the complexities regarding both calculation and refunding of 340B ceiling prices for new drugs and also the start-and-stop of regulatory issuances under the new Trump Administration. 

Manufacturers that participate in the 340B Program should be well on their way to developing systems and processes that will ensure compliance with the final rule and the calculation of ceiling prices and (if applicable) refund of amounts related to new drug prices. 

Arent Fox LLP’s Pharmaceutical & Device Compliance team regularly advises clients on commenting on proposed rules affecting the pharmaceutical industry, as well as on compliance with existing rules.