OMB Reviews Proposal to Add Prices to Pharma TV Ads

Regulatory NewsRegulatory News | 20 March 2019 |  By 

The Office of Management and Budget (OMB) this week began reviewing a proposed rule that would require drug companies to include list prices in direct-to-consumer television advertisements.

The rulemaking, now one step closer to finalization in some form, was released by the Centers for Medicare and Medicaid Services (CMS) last October and seeks to further shine a spotlight on drug and biologic prices, with the hope of reducing prices in the process.

HHS Secretary Alex Azar said in a speech Wednesday to the American Health Lawyers Association: "Particularly alert readers of OMB’s ROCIS website will note that, this week, we took a step toward finalizing a rule requiring the inclusion of drugs’ list prices in direct-to-consumer advertising. Each step we’re taking is important on its own and in concert with one another."

However, the rule is not expected to go into effect without a legal fight. In addition to experts questioning whether the move has enough behind it to actually lower prices, others questioned if the rulemaking would stand up to a First Amendment legal challenge.

In comments on the proposal from late last year, PhRMA, which has said such price disclosures will be misleading, also detailed the First Amendment principles that preclude CMS from compelling manufacturers to detail a drug’s list price in such TV ads. Sanofi also explained how the proposed rule will not achieve the government's objective of enabling consumers to make more informed and cost-conscious decisions that ultimately reduce CMS spending.

Other companies, meanwhile, have been taking matters into their own hands. J&J announced in February that it would list prices in TV ads beginning this month—a move praised by Azar.

Eli Lilly also launched a website with pricing information on four treatments: Emgality (galcanezumab-gnlm), Taltz (ixekizumab), Trulicity (dulaglutide) and Verzenio (abemaciclib).


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