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…
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”…
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Medical Products: Questions and Answers” (the “Guidance”).[1] The Guidance is a finalized version of the draft guidance released in 2023 (the “Draft Guidance”), which we covered here, and updates FDA’s collection of guidances on the topic, including its 2014 draft guidance titled, “Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices” (the “2014 Draft Guidance”)[2] and its 2009 guidance titled, “Good…
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…
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…
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…
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…
Continue Reading LDT Final Rule Series: Part 3 – Legal Challenges

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

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

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