Prescription and OTC Drugs

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On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and Biologics Guidance for Industry” (the “Draft Guidance”).[1] FDA’s so-called “accelerated approval” program is designed to expedite the development and review of new drugs and/or biologics that fulfill unmet medical needs for serious or life-threatening conditions by granting market approval to therapeutics that show promise by meeting a surrogate endpoint (so long as the drug and/or biologic sponsor promises to conduct post-market, confirmatory trials to verify safety and efficacy). The Draft Guidance updates FDA’s policies and procedures for accelerated approval, including heightened requirements for confirmatory trials and a new process for expedited withdrawal of approval, based on mandates from the 2023 Consolidated Appropriations Act, which was penned to address concerns over the lag time between initial approvals under the accelerated approval program and final approval following the successful completion of confirmatory trials.[2] FDA is inviting comments to the Draft Guidance, with a deadline set for February 2, 2025.Continue Reading New Accelerated Approval Guidance Underscores Need for Accountability

In the Law360 article “Key Takeaways From FDA’s Latest Social Media Warnings,” Sheppard Mullin FDA Regulatory attorneys Dominick DiSabatino, Cortney Inman and law clerk Julian Klein cover the FDA’s Office of Prescription Drug Promotion October 31 untitled letter to Merz Pharmaceuticals GmbH regarding the social media promotion of Xeomin, an injectable for improving glabellar lines. The FDA critiqued the video on Xeomin’s Instagram account, noting misleading risk and efficacy presentations.Continue Reading Key Takeaways from FDA’s Latest Social Media Warnings

On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television advertisement (TV ad) for UBRELVY® (ubrogepant) tablets, for oral use (Ubrelvy).[1] Ubrelvy is indicated for the acute treatment of migraine with or without aura in adults.[2] FDA concluded that the TV ad – which featured tennis star Serena Williams – misleadingly suggested that Ubrelvy provides greater benefits than has been demonstrated and was therefore misbranded under FDA regulations.Continue Reading Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?

On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional communications made on its Healthcare Provider Branded Website for its accelerated approval drug, KRAZATI™ (adagrasib) tablets, for oral use (Krazati).[1] Krazati is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.Continue Reading Krazati Untitled Letter: A Cautionary Tale for CFL Promotion of Accelerated Approval Drugs

On July 17, 2024—but just recently posted to the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) website—FDA issued its second untitled letter (letter) of the year to Kaleo, Inc. (Kaleo) over social media promotion of AUVI-Q® (epinephrine injection, USP). The social content was posted on the personal Instagram account of Brittany Mahomes—yes, that Mahomes. While the letter is splashy by virtue of its target and the message presented, the content, rationale, and findings by FDA are not surprising—linking to important safety information (ISI) alone is not enough, especially when the product is intended to treat a potentially life-threatening condition in children. FDA made a tough choice to go on the record against a message that looked like a public service announcement about recognizing anaphylaxis and talking to a doctor about your kids’ health.Continue Reading FDA’s Second Untitled Letter of the Year – An Apparently Tough Choice Between Raising Awareness and Public Safety for Anaphylaxis Drugs

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and examples for firms who choose to address misinformation about or related to their approved or cleared drug or device.[1] This guidance revises and replaces FDA’s 2014 draft guidance titled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” Social media users from 2014 will appreciate how different the world looks today and why—even though it took FDA ten years—this revision is a welcomed shift making it more straightforward for firms to respond to misinformation.Continue Reading FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)[1]—ruling that the Act’s annual price increase reporting requirement is unconstitutional and, therefore, unenforceable.[2] Following the District Court’s decision, the Oregon Department of Consumer and Business Services (“DCBS” or the “Department”) issued a bulletin indefinitely suspending the annual price increase reporting requirement.[3] However, the Department confirmed its intent to appeal the District Court’s decision,[4] leaving the future of the reporting requirement relatively uncertain.Continue Reading Oregon Prescription Drug Price Transparency Act in Limbo

On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis) regarding a promotional, direct-to-consumer broadcast advertisement (TV Ad) for KISQALI® (ribociclib) tablets, for oral use, indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:Continue Reading FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance). The CCN Final Rule Guidance was released to advise small entities seeking to understand and comply with the standards established in the final rule, “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule).Continue Reading FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the ever-expanding puzzle that is FDA’s regulatory scheme for digital health products. The Guidance clarifies how FDA plans to apply its drug labeling regulations to software products that “supplement, explain, or otherwise textually relate to” the use of a prescription drug. As most of FDA’s recent regulatory activity with respect to medical software regulation has been in the device space, this Guidance represents a concerted focus by the Agency to unify its approach to digital health across all regulated categories (e.g., drugs, biologics, and devices).Continue Reading FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Exeltis USA Inc. (Exeltis) regarding a promotional social media sponsored post for SLYND® (drospirenone) oral progestin tablets, indicated for use by females of reproductive potential to prevent pregnancy (Slynd).[1] The post appeared on Facebook,[2] and, in addition to being false and misleading, also was not submitted to OPDP at the time of publication as required by FDA regulations. This is only the second untitled letter from OPDP of the year, both of which have focused on false and misleading promotional messaging.Continue Reading FDA’s Office of Prescription Drug Promotion Issues Second Untitled Letter of the Year to Exeltis for Misleading Statements Relating to SLYND®