On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft Guidance”). The Draft Guidance responds to FDA’s new authorities and responsibilities in administering the accelerated approval program under the 2023 Consolidated Appropriations Act, which FDA addressed at a high level in an initial draft guidance about a month ago (see our article on this initial guidance here). The new Draft Guidance narrows in on heightened requirements for confirmatory trials and outlines the granular process for ensuring that confirmatory trials are “underway” to verify the clinical benefits of accelerated approval drugs. FDA is inviting comments to the Draft Guidance, with a deadline set for March 10, 2025.Continue Reading FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials

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5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and Biologics Guidance for Industry” (the “Draft Guidance”).[1] FDA’s so-called “accelerated approval” program is designed to expedite the development and review of new drugs and/or biologics that fulfill unmet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 The Draft Guidance updates FDA’s policies and procedures for accelerated approval, including heightened requirements for confirmatory trials and a new process for expedited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and final approval following the successful completion of confirmatory trials.[2] FDA is inviting comments to the Draft Guidance, with a deadline set for February 2, 2025.Continue Reading New Accelerated Approval Guidance Underscores Need for Accountability

This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration (“FDA” or the “Agency”) final rule in May, which established a staged plan that will phase out FDA’s previous policy of enforcement discretion for LDTs; second, the overturn of the Chevron Doctrine in Loper v. Raimondo in late June; and third, the recent election of Donald Trump as the forty-seventh president of the United States. And of course there are the legal challenges—difficult to predict with the maelstrom of news over the past few months. However, we now have the context necessary to assess these challenges and make some informed predictions about their future. While a host of legal theories have been lobbed at the rule, they each underscore a common sentiment—agencies should not be able to create their own authority, a position strengthened by the overturn of Chevron and election of Trump.Continue Reading LDT Final Rule Series: Part 3 – Legal Challenges

Earlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software. FDA’s stated goal for the Guidance is to “to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices,” and it represents notable progress in the Agency’s scramble to keep with – or at least prevent being too far outpaced by – the rapid pace of AI/ML innovation, as used in digital health technology.Continue Reading FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

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

Last month, the U.S. Department of Justice (“DOJ”) quietly updated its March 2023 guidance on the evaluation of corporate compliance programs.[i] Of course, DOJ did not conduct a major rewrite, but interestingly, the updated guidance emphasizes the impact, and evaluation, of emerging technologies on compliance as well as the importance of data when assessing compliance programs.Continue Reading DOJ Updates Guidance on Evaluation of Corporate Compliance Programs

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

In this second installment of our nine-part deep-dive into the U.S. Food & Drug Administration (“FDA” or “the Agency”) final rule on Laboratory Developed Tests (“LDTs”) – which established a staged plan that will phase out the Agency’s previous policy of enforcement discretion for LDTs – we are taking a closer look at the response to the rule, not only from laboratories and other industry stakeholders but also from members of the legislature. The long and short of it is – people are not happy!Continue Reading LDT Final Rule Series: Part 2 – Response to the Rule