Further Delays in 340B Drug Ceiling Price Rule / by Joe Furia

Ann-Marie Alameddin, Vice President of Strategy and General Counsel

Once again the Department of Health and Human Services (HHS) has delayed the implementation of its final rule on 340B drug ceiling prices and civil monetary penalties for manufacturers to July 2019. The 340B ceiling price and civil monetary penalties rule were intended to shine needed light on drug manufacturer price increases and hold drug manufacturers accountable for price overcharging. HHS reasoning behind this 5th delay would be that it will provide regulated entities with needed time to implement the requirements of the rule, as well as allowing a more deliberate process of considering alternative and supplemental regulatory provisions, and to allow for sufficient time for any additional rulemaking.