FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

OMB Takes Up Proposed Rule Requiring List Prices in TV Ads

March 28, 2019

A proposed rule requiring drugmakers to include the list price of their products in TV ads has advanced a step closer to finalization.

The Centers for Medicare and Medicaid Services, which issued the proposal last fall, sent it over to OMB on Monday for a final review. The proposed rule applies to all prescription drugs and biological products covered by Medicare or Medicaid.

In comments on the proposal, PhRMA argued that CMS doesn’t have the authority to regulate drug ads and cited potential First Amendment conflicts that would likely be the focus of a court challenge.

Perhaps hoping to preempt a mandate, PhRMA has issued its own voluntary guidelines for television ads, urging member companies to direct potential customers to sites that contain drug list prices.

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