A judge for the US District Court for the District of Columbia on Monday struck down a final rule from the Department of Health and Human Services (HHS) requiring drug manufacturers to disclose their prices in TV ads.
The final rule was an attempt by the Trump administration to combat rising drug prices. Specifically, drug manufacturers would have to disclose the list price of a 30-day supply of any drug that is covered through Medicare and Medicaid and costs at least $35 a month. HHS announced the final rule in May, and the regulation was set to go into effect July 9, 2019.
The rule faced immediate backlash from the pharmaceutical sector. In response to the final rule, three drug companies—Amgen, Merck and Eli Lilly—filed suit, claiming HHS needed congressional approval to impose such a requirement. The companies also contended the rule was “compelled speech” that would have violated their First Amendment rights. In contrast, HHS pointed to its general power under the Social Security Act (SSA) as the source of authority for the final rule.
Judge Amit Mehta sided with the pharmaceutical companies and stated, “HHS cannot do more than what Congress has authorized.” Mehta explained that the SSA contains no explicit delegation of authority to the HHS to regulate the televised marketing of drugs. Mehta noed that Congress did not expect HHS to speak with the force of law on this issue. He found that HHS was attempting to regulate market actors that are not direct participants in Medicare or Medicare programs (programs over which HHS has authority). As a result, the court vacated the rule.
The Trump administration is expected to appeal the decision.