The American Hospital Association and several other groups delivered on their promise as they filed suit Monday against the Department of Health and Human Services (HHS). The suit, filed in U.S. district court in the District of Columbia, seeks a preliminary injunction to keep a new Medicare 340B reimbursement rule from going into effect in January. Medicare currently reimburses qualifying hospitals, which enjoy steep discounts on the 340B outpatient drugs, at the average sales price (ASP) plus 6 percent. Under the new rule, it will pay ASP minus 22.5 percent for the physician-administered drugs. In addition to an injunction, the suit asks for a declaratory judgment that the change violates HHS' statutory authority, as well as the purpose and design of the 340B program. (See BioWorld, Nov. 3, 2017.)

The American Medical Association (AMA) expanded the scope of its federal and state advocacy efforts to increase transparency of drug pricing at its interim meeting. Under the new policy, the AMA will oppose contract provisions that prohibit pharmacists from disclosing that a patient's copay is higher than the drug's cash price, advocate for policies that prohibit unjustifiable price increases on prescription drugs, develop model state legislation on the development and management of pharmacy benefits, and continue its grassroots campaign to expand drug pricing transparency among drug manufacturers, pharmacy benefit managers and health plans and to communicate the impact of each of those segments on drug prices and access.

The FDA hit Lupin Ltd., of Mumbai, with a warning letter citing problems with how the company dealt with out-of-specification results at several of its drug manufacturing plants and set hold times that were inadequate to assure drug quality. "These repeated failures at multiple sites demonstrate that your company's oversight and control over the manufacture of drugs is inadequate," the FDA said. The agency instructed Lupin to immediately and comprehensively assess its global manufacturing operations to ensure that the systems and processes, as well as the drugs, conform to FDA requirements.