340b Update: HRSA Indicates it Lacks Authority to Enforce 340b Program Guidance

Section 340b creates a price ceiling that requires manufacturers to maintain drug prices at or below the ceiling. In a public statement, the Health Resources and Services Administration (HRSA) recently said its guidance documents related to the 340b Drug Pricing Program (340b Program) are unenforceable. This is a response to Eli Lilly and Co.’s notice to 340b entities, explaining Cialis can no longer be provided at the 340b pricing, challenging HRSA’s 340b statute interpretation that has allowed drugs to be provided at 340b pricing. From HRSA’s response, it seems unlikely that the Administration will act against a manufacturer or organization unless they deliberately violate the statute. HRSA, in response to Eli Lilly’s notice, states that they can only act if there is a clear violation against 340b.