USA – Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a rulemaking that would require pharmaceutical list prices to be shown in direct-to-consumer (DTC) drug advertisements on television.

The rule, which was finalized in May and is set to take effect in July, requires that television advertisements for prescription drugs or biological products with a list price of $35 or more contain a statement indicating the Wholesale Acquisition Cost (also referred to as WAC or the list price) for a typical 30-day regimen or for a typical course of treatment.

But in their lawsuit, file in the US District Court for the District of Columbia, the drugmakers took issue with the fact that consumers do not pay the list prices that would be advertised under the rule.

“The rule thus directs manufacturers to advertise to consumers the price that manufacturers charge to wholesalers, even though these are two entirely different concepts,” the complaint says. “And because third-party payers (like insurance plans or government health programs) generally cover the bulk of the costs of a branded drug, the overwhelming majority of patients do not pay anything remotely close to the Wholesale Acquisition Cost of an advertised drug at the pharmacy or through their provider.”…