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# Court Invalidates HHS Rule on DTC Pricing Disclosures
- URL: https://www.fdaweb.com/court-invalidates-hhs-rule-on-dtc-pricing-disclosures/
- Published: 2019-07-08T12:00:00.000Z
- Updated: 2026-09-15T01:35:54.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5144477

On the eve a rule was to go into effect requiring drug pricing information in direct-to-consumer ads, the Washington, DC federal district court [ruled 7/8](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2019cv1738-32&ref=fdaweb.com) that HHS lacks the statutory authority under the Social Security Act to mandate such disclosures. The 6/14 [complaint](http://www.fdaweb.com/download.php?file=6059709-0--19527.pdf) from Merck, Eli Lilly, Amgen and the Association of National Advertisers, also contended that the rule violated the companies’ First Amendment rights, and it would mislead patients about their out-of-pocket costs for prescription drugs.

“Neither the Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices,” the court opinion said. “The rule is therefore invalid. In view of this holding, the court does not reach plaintiffs’ First Amendment challenge.”

In reaching his decision, Obama appointee judge **Amit P. Mehta** said he was not taking any view on the wisdom of requiring drug companies to disclose prices. “That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”