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.
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.