HRSA delays to July effective date of 340B drug ceiling price rule

The Health Resources and Services Administration today delayed to July 1, 2018 the effective date of its final rule on 340B drug ceiling prices and civil monetary penalties for manufacturers. “We are delaying the effective date of the Jan. 5, 2017, final rule to July 1, 2018, because the delay will provide stakeholders with additional time to come into compliance and provide time to consider the substantial questions of fact, law and policy raised by the rule,” the agency said. AHA had opposed any further delay of the rule, which has been subject to multiple delays since January. “The agency’s rulemaking on these issues began seven years ago, shortly after the passage of the ACA,” AHA Executive Vice President Tom Nickels said in comments submitted last week. “This process included an advance notice of proposed rulemaking, a notice of proposed rulemaking, a final rule and now an interim final rule. Therefore, there have been extensive opportunities for stakeholders to provide feedback and ample time for HRSA to consider such feedback.”