Merck, Eli Lilly and Amgen face the Department of Health and Human Services (HHS) in court again Monday in the ongoing battle over the agency’s rule to require drug prices in TV ads.
The setting is the U.S. Court of Appeals in Washington, D.C., where the case has landed after a lower court ruled against HHS and in favor of the pharma companies and partner plaintiff, the Association of National Advertisers (ANA).
The district court ruling in July blocked the mandate from going into effect because the court determined HHS does not have the statutory authority to adopt the rule.
The advertising trade group and the pharma companies plan to continue focusing on that lack of authority in its argument today, said Dan Jaffe, head of regulatory for ANA. But attorneys for the plaintiffs will also contend that the mandate violates the First Amendment. Rick Bress, a partner at Latham & Watkins in Washington, D.C., will continue to argue the case for Merck and the plaintiffs.
Jaffe says he's confident his side will prevail in appeals court. But a win likely wouldn't end the battle; the HHS could well take its argument to the Supreme Court.
Alternately, Congress may take the initiative, as it has before. U.S. senators Richard Durbin, an Illinois Democrat, and Charles Grassley, a Republican of Iowa, have hawked versions of the idea for years, and, in 2018, got a measure approved in the Senate. However, the amendment to a larger bill was later stripped in the House, much to the two senior senators' dismay.
“Durbin and Grassley are going to come back at us if this is not handled by the HHS ruling,” Jaffe said. “They’re not-nothing players. So when you have not-nothing players going against a disfavored group, which is the prescription drug industry, it’s not certain that they won’t be able to do it.”
The idea to add drug prices to advertising is popular not only with legislators, but also consumer and other industry and advocacy groups. AARP is among the organizations that filed an amicus brief in support of HHS in the case.
The powerful group, which works on behalf of older Americans, said it urges the court to reverse the lower court decision and allow the DTC ruling to go forward so that consumers can “get the essential drug pricing information they need to allow them and their health care providers to make the best decisions for their care.”