News Briefs

The Supreme Court has agreed to hear a case that ultimately could upend state-based efforts to regulate PBMs. The lawsuit, which was brought by the Pharmaceutical Care Management Association (PCMA), challenges a 2015 Arkansas law that requires PBMs to reimburse pharmacies at or above their wholesale cost for generic drugs. The case boils down to whether PBMs are acting as agents under the Employee Retirement Income Security Act of 1974 (ERISA) and therefore are exempt from state-level regulation, or whether they are a “non-interested party and therefore subject to regulation,” says Jeff Myers, founder of health care consulting firm OptDis. He tells AIS Health that he believes it’s likely the high court will side with PCMA and the PBM industry, agreeing that ERISA bars state laws like the one at issue in Arkansas. View court documents related to the case at https://bit.ly/3aCjOmw.

Democrats and Republicans on the House Energy and Commerce Committee sent FDA Commissioner Stephen Hahn a joint letter asking why generic drug approvals are so slow. Members cited EpiPen, noting that the drug took 10 years to approve in the FDA’s expedited track, and mentioned a 2018 Government Accountability Office report that recommended the FDA offer more guidance to pharma. The FDA only issued five of a possible 28 complex generic drug approvals in fiscal year 2017. View the letter at https://bit.ly/2REbyKh.

© 2021 MMIT

AIS Health Staff

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