The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements. The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie that their television ad for migraine medication, Ubrelvy, featuring Serena Williams “…makes false or misleading representations and suggestions about the efficacy of Ubrelvy.” The letter focused on efficacy claims made in the advertisement. The 30-second ad shows Serena Williams experiencing symptoms of a migraine while getting ready to go on stage. The ad then goes on to show how one dose of Ubrelvy helped Serena feel better, and she is later shown smiling and laughing as she walks onto a talk show stage. The FDA’s letter explains that in the original storyboard for the ad, Serena experiences migraine pain in the afternoon and feels better before her talk show appearance in the evening. The FDA contends that the televised ad does not accurately portray the time lapse that was in the storyboard version. The FDA stated that, “This compelling before-and-after presentation in conjunction with claims such as, “One dose works fast to eliminate migraine pain” and “UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN” (emphasis added) misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” The letter also claims that the ad “…misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.”
Continue Reading FDA Calls Out a Migraine TV Ad for Misleading ViewersCMS Outlines Plan for Medicare Beneficiaries to Pay Prescription Drug Costs in Monthly Installments
On August 21, 2023, the Centers for Medicare & Medicaid Services (CMS) released draft guidance, pursuant to the Inflation Reduction Act (IRA), to implement the Medicare Prescription Payment Plan, a new program to help Medicare Part D beneficiaries more easily afford their out-of-pocket (OOP) costs for prescription drugs. The IRA, among other provisions aimed at lowering prescription drug costs for Medicare beneficiaries, requires, starting in 2025, that Medicare Part D plan sponsors offer beneficiaries the option to pay their OOP costs for prescription drugs monthly over a year instead of at the point of sale. Under the new program, referred to as the Medicare Prescription Payment Plan, Part D sponsors must pay the pharmacy the OOP cost-sharing that beneficiaries would have paid if they were not in the program. Part D plan sponsors then will bill beneficiaries monthly for their OOP responsibility.
Continue Reading CMS Outlines Plan for Medicare Beneficiaries to Pay Prescription Drug Costs in Monthly InstallmentsPodcast: Pharmacy Benefit Managers
Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records, talk with Todd Rosenberg about PBMs and the regulatory issues they have faced recently.
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