340B Reforms in Doubt After Judge Curbs HHS Power

Emily Cook said that a federal judge’s decision that curbed the power of HHS to require drugmakers discounts on so-called orphan drugs under the 340B drug program “does call into question the likelihood of [HHS] moving forward with release of the proposed rule as planned.” Ms. Cook noted that “there are several different approaches” HHS could take in response, such as administering 340B activity through guidance “rather than issuing formal regulations.”