340B Orphan Drug Proposed Rule

On May 20, HRSA published a Notice of Proposed Rulemaking concerning how the Orphan Drug exclusion will be implemented for certain eligible healthcare organizations participating in the 340B Drug Pricing Program. The proposed rule would prevent organizations from receiving 340B pricing on Orphan Drugs when they are used to treat the rare conditions that gave them orphan designations, but not when the drug is used for the treatment of other maladies – some of which are routinely and widely treated by designated Orphan Drugs. Affected health care organizations will be required to develop auditable systems to ensure that they are not using Orphan Drugs purchased under the 340B Drug Pricing program for orphan designated indications. HRSA encourages the submission of written comments during the 60-day comment period, and will carefully consider all of the comments received. Comments are due by July 19, 2011. For more information and to access the proposed rule, click here.