Amgen, along with Merck and Co., Eli Lilly and Company, and the Association of National Advertisers, have filed suit against the US Department of Health and Human Services’ (HHS) regarding a recent HHS rule requiring list prices to be included for medicines being advertised on television.

The recent rule was finalized by the HHS in May 2019 and is scheduled to take effect July 9, 2019 and would require direct-to-consumer television advertisements for certain pharmaceuticals and biologics to state the list price of that medicine being advertised. The lawsuit seeks to prevent the rule from taking effect on July 9, 2019.

The HHS rule is part of an overall plan to address the cost of prescription drugs in the US. That plan, American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, was announced in May 2018 by the Trump Administration and the HHS and laid out four strategies: boosting competition, enhancing negotiation, creating incentives for lower list prices, and bringing down out-of-pocket costs. To create better incentives for lower list prices, the plan called for HHS to consider requiring the inclusion of list prices in direct-to-consumer advertising.

Amgen, one of the litigants in the lawsuit filed against the HHS, offered the company’s position on the disclosure of list prices in direct-to-consumer television advertising. “Amgen agrees with the Administration that patients need clear and relevant information to understand what they can expect to pay for their medicines…” said the company in a June 14, 2019 statement. “What Amgen doesn’t agree with is a government-prescribed approach as required in the new DTC [direct-to-consumer] rule. Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments, and patients themselves, by requiring disclosure of list price. Most importantly, it does not answer the fundamental question patients are asking: “What will I have to pay for my medicine?”

Source: Amgen