Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the “Agency’s”) controversial rule that ended its longstanding policy of enforcement discretion for laboratory-developed tests, or “LDTs,” purporting to regulate them as “devices” under the Food, Drug, and Cosmetics Act (the “FDCA”) (the “LDT Rule” or the “Rule”). While this is a clear win for companies in the diagnostic and lab services space, we are now left wondering – is there any path forward for the LDT Rule? It’s not looking too likely but, these days, anything could happen.Continue Reading LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the “Letter”)[1] that was issued on February 3, 2025 to Edenbridge DBA Dexcel (“Dexcel”) over allegedly misleading promotional materials for the multiple myeloma drug Hemady® (dexamethasone) involving—you guessed it—a DOF reference. This marks OPDP’s first untitled letter of the year and the first under the new administration. The letter is relatively uninventive in terms of enforcement angles—leading with a garden-variety failure to present “any” safety information—but it does serve as a reminder that FDA can and will ask for DOF references, especially those that substantiate Consistent with FDA-Required Labeling (“CFL”) promotional materials. And of course, despite all the news about regulatory cuts affecting FDA, OPDP still appears alive and well.Continue Reading Reminder: FDA Does, In Fact, Review DOF

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (the “Guidance”).[1] The Guidance is a finalized version of the draft guidance released in 2023 (the “Draft Guidance”), which we covered here, and updates FDA’s collection of guidances on the topic, including its 2014 draft guidance titled, “Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices” (the “2014 Draft Guidance”)[2] and its 2009 guidance titled, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” (the “2009 Guidance”).[3]Continue Reading Finally, FDA’s Final Word on Unapproved Use Communications

Gathering topics and reviewing the articles for our annual Top-of-Mind publication is always one of my favorite yearly endeavors, allowing me to talk to clients, colleagues and industry experts about the overall state of the life sciences industry. The timing of this publication usually coincides with the J.P. Morgan Healthcare Conference, providing a key opportunity to vet our articles. The breath and scope of comments, concerns, predictions have been remarkable.Continue Reading 2025 Top-of-Mind Issues for Life Sciences Companies

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the “Draft Guidances”). The Draft Guidances hit on the topics of in vitro diagnostic (“IVD”) devices, artificial intelligence (“AI”) enabled device software functions, and pulse oximeters. This uncharacteristic deluge of guidance all within the span of a week illustrates the Agency’s desire to disseminate policy ahead of the incoming administration – especially as it relates to medical devices, which for a variety of reasons that any follower of this blog could intuit, have become a hot-button issue across the various corners of the healthcare and life sciences industries.Continue Reading FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

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