List prices in TV drug ads are back in play. The Trump administration filed an appeal Wednesday, six weeks after a judge struck down its regulation requiring pharma companies to add the list price of a drug into its TV advertising.
Merck, Amgen and Eli Lilly, along with the Association of National Advertisers (ANA), had won a reprieve on July 8, one day before the regulation was set to take effect. The U.S. District Court in Washington D.C. vacated the rule on the grounds that HHS did not have the statutory authority to adopt it.
The drugmakers and advertising association filed a lawsuit in June, after HHS formally announced a July 9 start date for the regulation it had been working on for a year.
District Judge Amit Mehta said in her opinion that the Social Security Act, which HHS used as its basis for the regulation, does not “empower HHS to issue a rule that compels drug manufacturers to disclose list prices.”
The opinion was careful to note that the court did not question HHS’ motives nor did it have an opinion on the wisdom of the rule. Instead, it seemed to kick the question to Congress. “The responsibility rests with Congress to act,” the ruling noted.
Dan Jaffe, ANA’s head of government relations, said today that his organization is now working with the other plaintiffs on a response. When asked what comes after that, he said he anticipates a court of appeals hearing will be set. HHS has not revealed what argument it will pursue, but Jaffe said he is confident ANA and the pharma companies are in strong legal standing on both points they argued. That is, the lack of authority the HHS has to adopt the ruling and the second issue not addressed in the federal court dismissal, that the regulation violates the First Amendment.
Regardless of the outcome in court, the pharma industry has already adopted its own guidelines for publishing drug prices. Its "DTC Principles" plan, adopted through industry trade group PhRMA, commits to posting prices on websites rather than TV.
Member pharma companies agreed that “all DTC television advertising that identifies a medicine by name should include direction as to where patients can find information about the cost of the medicine … including the list price and average, estimated, or typical patient out-of-pocket costs, or other context about the potential cost of the medicine.” The plan went into effect this spring.
Johnson & Johnson voluntarily took the extra step of adding list price to its TV ads, while others built out websites to provide cost information. Eli Lilly, for instance, at lillypricinginfo.com, now lists the wholesale price along with insurance and patient cost-assistance programs for 10 of its drugs.
默克（Merck），安进（Amgen）和礼来（Eli Lilly），以及全国广告协会（ ANA ），赢得了一个缓刑7月8日，一天前，该规定将生效。华盛顿特区的美国地区法院撤销了该规则，理由是 HHS 没有法定权力通过该规则。
地区法官阿米特·梅赫塔( Amit Mehta )认为， HHS 作为监管依据的《社会保障法》( Social Security Act )并不“授权 HHS 发布一条规则，迫使药品制造商披露上市价格”。
该意见谨慎地指出，法院既没有质疑 HHS 的动机，也没有对该规则的智慧发表意见。相反，它似乎把问题推给了国会。裁决指出：“国会有责任采取行动。”
ANA 政府关系主管丹·贾菲( Dan Jaffe )今天表示，他的组织目前正与其他原告合作，以作出回应。当被问及之后会发生什么时，他说他预计上诉法庭将开庭审理。HHS 还没有透露它将寻求什么理由，但是 Jaffe 说他有信心 ANA 和制药公司在他们争论的两个问题上都有很强的法律地位。也就是说，卫生和公众服务部没有权力通过这一裁决，第二个问题没有在联邦法院驳回中得到解决，因为该条例违反了第一修正案。
不管法庭结果如何，制药业已经通过了自己的药品价格发布指南。它的“ DTC 原则”计划是通过行业贸易组织美国药物研究和制造商协会（PhRMA）采用的，承诺在网站上发布价格，而不是电视。
成员制药公司同意，“所有以名称识别药品的 DTC 电视广告都应包括患者可在哪些地方找到有关药品成本的信息……包括定价和平均、估计或典型的患者自付费用，或关于药品潜在成本的其他背景。”这个计划今年春天开始生效.
强生公司自愿采取额外措施，在电视广告中增加定价，而其他公司则建立网站提供成本信息。例如， EliLilly 在 lillipricinginfo 。现在， com 列出了批发价格以及10种药品的保险和病人成本援助计划。