The pharma industry can breathe at least a temporary sigh of relief after a federal judge blocked an about-to-go-into-effect rule requiring drugmakers to disclose a treatment’s list price in direct-to-consumer TV ads.
Judge Amit Mehta overturned the rule on Monday, hours before drugmakers would have had to comply with it. In his decision, Mehta said the issuing agencies, the Department of Health and Human Services and the Centers for Medicare and Medicaid Services, overstepped their authority.
The lawsuit was filed in mid-June by Merck, Eli Lilly, Amgen and the Association of National Advertisers, which also filed a motion to stay the rule while the courts made their decision. However, instead of issuing the stay, Mehta blocked the rule entirely.
The plaintiffs had argued that the rule violated their First Amendment rights and that a list price would confuse patients. Yet the final decision didn’t touch on those arguments and instead focused on whether HHS has the authority to issue such a rule.
In his ruling, the judge wrote that regulations on drug advertising were put in place by Congress through the Food, Drug and Cosmetic Act, not through a government agency. HHS argued that it has the authority to draw up the rule via the Social Security Act, but Mehta disagreed.
“The [list price] disclosure rule feels like agency action in search of a statutory home,” the ruling reads.
The judge added in the ruling that if the Trump administration wants to require pharma companies to disclose prices in direct-to-consumer TV ads, it should go through Congress, not HHS.
“Congress knows how to prescribe the content of drug advertising when it chooses to do so,” the opinion reads. “Congress has directly addressed the subject of television drug advertising and pre-review of such advertisements. Yet, for decades Congress has not addressed the disclosure of drug prices.”
HHS can appeal the ruling. The government agency did not respond to a request seeking comment.