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U.S. drugmakers filed a lawsuit on Friday challenging a new government regulation that would require them to disclose the list price of prescription drugs in direct-to-consumer television advertisements. The lawsuit was jointly filed by Amgen Inc, Merck & Co, Eli Lilly and Co and the Association Of National Advertisers in the U.S. district court for the district of Columbia. (6/14)

“We believe the new requirements may cause patients to decide not to seek treatment because of their perception that they cannot afford their medications, when in fact many patients do not pay anything near list price,” Merck, whose top-selling product is the pricey cancer drug Keytruda, said in a statement. Lilly, which is one of three manufacturers of insulin under scrutiny for rising list prices — said the federal government had overstepped its authority. “The impetus for the lawsuit is drug prices in TV ads, but the crux of it is H.H.S. not having the authority to mandate this action,” the company said in a statement, referring to the Department of Health and Human Services. (Thomas, 6/14)

"That 'list price' is not, as patients will likely infer from the context, a suggested sales price for the retail transactions contemplated in advertisements," the brief stated. "Rather, the rule requires manufacturers to use the gross price at which a prescription drug is offered to wholesalers, before rebates, discounts, or any other adjustments are applied. And the mandated price figure not only ignores such wholesale price adjustments, but also fails to account for the insurance coverage that a significant majority of Americans have for their retail purchases of prescription drugs." (Luthi, 6/14)

The proposed rule was finalized in May by the U.S. Department of Health and Human Services and is set to take effect in July. It is among the efforts by the Trump administration to make health care more affordable in the U.S. Officials also want to stop billions of dollars in annual rebates that drugmakers give middlemen in Medicare that are known as pharmacy-benefit managers. The government has said the proposed rule would increase transparency around prices and allow patients to make informed decisions based on cost. Government officials also have said the rule could spur drug companies to reduce prices. (Hopkins, 6/14)

In a supporting legal analysis, Ravi Dhar, a Yale professor and paid consultant to the plaintiffs, argued that advertisements’ inclusion of wholesale acquisition cost — a common industry pricing benchmark — is “likely to mislead consumers into overestimating their actual out-of-pocket costs and is not likely to lead to more informed choices.” Almost immediately after the Trump administration first proposed the policy, drug makers began to question the federal government’s legal standing for requiring the price disclosures. They also argued that list prices are often not effective barometers of patient expense, given the variance between insurers, providers, and patient assistance programs, among other factors. (Facher, 6/14)

A court battle over the rule could hamper part of the administration’s blueprint to drive down drug prices with regulation. Congress so far has failed to pass any major legislation, despite drug prices being an issue on which Republicans and Democrats can find common ground. (Armstrong, 6/14)

Progressive lawmakers this week exacted a major concession from House Speaker Nancy Pelosi: a pledge for the federal government to negotiate prices for a far larger group of drugs than initially proposed. The new plan, confirmed to STAT by Democratic aides, would have the federal government negotiate for the price of at least 250 drugs covered by Medicare — compared to at least 25 drugs in the initial proposal. (Facher, 6/14)