By: Carmela Crimeni
On April 8, 2015, HRSA submitted a 340B Civil Monetary Penalties for Manufacturers proposed rule (RIN: 0906-AA89) to the Office of Information and Regulatory Affairs (OIRA) for review. The text of the rule has not yet been published, but according to the abstract at www.reginfo.gov, this rule, “would amend section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program.”
The rule is currently pending Executive Order 12866 review. EO 12866, requires OIRA review of all significant regulatory actions before they take effect. The period for OIRA review is limited by EO 12866 to 90 days, however, there is no minimum period for review.