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Audrey Mercer

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Audrey Mercer is an associate who specializes in the life sciences and healthcare industries and works out of the firm’s Dallas office.

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Just before Thanksgiving, the Food and Drug Administration’s (“FDA’s”) Office of Prescription Drug Promotion (“OPDP”) silently published three untitled letters, furthering this administration’s promise to crack down on direct-to-consumer (“DTC”) prescription drug advertising.[1] The letters (which we’ll call “Letter 1,” “Letter 2,” and “Letter 3”) addressed familiar enforcement themes, such as omission or minimization of risk information, ad presentation and form, and promotion consistent with FDA-required labeling (“CFL”). The letters appeared to have been leftovers from the shutdown, dated from earlier in September when the crackdown was in full swing. This is why we refresh these pages daily.Continue Reading What to Watch: Continued DTC Advertising Enforcement

Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”).[1] What we have found is a collection of seemingly contradictory signals, keeping us guessing as to whether we will see an increase or decrease in HCT/P regulation – either by written regulation or enforcement. To date, aside from some recent enforcement,[2] not a whole lot has changed.Continue Reading What to Watch: Human Cell and Tissue Product Regulation

In late September, the U.S. Food & Drug Administration (“FDA”) issued three draft guidances related to cell and gene therapy (“CGT”) products: (1) Innovative Designs for Clinical Trials of CGT Products in Small Populations (the “Innovative Designs Guidance”), (2) Postapproval Methods to Capture Safety and Efficacy Data for CGT Products (the “Postapproval Methods Guidance”), and (3) Expedited Programs for Regenerative Medicine Therapies for Serious Conditions (the “Expedited Programs Guidance”) (each, a “Guidance”). Although none of these Guidances appear to significantly alter the existing landscape for CGT products, they do reflect a willingness on behalf of FDA to get creative about how to bring these products to market, especially where they are intended to address rare diseases and/or small populations – an area where traditional drug development paradigms are strained.Continue Reading FDA Touts Continued Commitment to Cell and Gene Therapy Products through Trio of Guidances

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a torrent of untitled letters, 40 in total, just days after rumblings that FDA would be cracking down on direct to consumer (“DTC”) advertising of pharmaceuticals.[1] This enforcement flurry—which we will digest in a later blog post, given its complexity—did not stop there as just a week later, on September 16, 2025, FDA released about 80 warning letters. We have forecasted this for months, and now, we believe this wave of action to be the tip of the enforcement iceberg.[2]Continue Reading FDA Unleashes Wave of Enforcement: The Industry Faces a Crackdown on Drug Advertising

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product qualifies as an unregulated wellness product[1] and alleging, instead, that the product qualifies as a “device”[2] under the Food, Drug, and Cosmetics Act (“FDCA”) (i.e., is intended for use in the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition).[3] FDA concludes, therefore, that the product is misbranded and adulterated, as WHOOP is currently marketing the product with a cleared 510(k) notification or approved premarket application (“PMA”). Continue Reading What to Watch: WHOOP Warning Letter

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same. As discussed in greater length in that article, key players in the new administration, such as Health and Human Services (“HHS”) Secretary, Robert F. Kennedy, Jr. (“Secretary Kennedy”) – who spoke publicly about this initiative even before his appointment and, soon after he was appointed, assembled a roundtable of government and industry personnel to discuss ways to reduce the regulatory burden for stem cell therapies soon after he took office[1] – have been vocal about the need to lower barriers to market entry for stem cell manufacturers.Continue Reading What’s Going on with Human Cell and Tissue Products?

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”)[1] for allegedly promoting its diagnostic product (which was labeled for research use only “RUO” and therefore, not cleared or approved by FDA) for clinical purposes in violation of the U.S. Food, Drug, and Cosmetics Act (the “FDCA”).[2] The Agena Warning Letter – the first issued to an RUO product manufacturer in over five years – left the industry wondering whether FDA intended to ramp up enforcement against manufacturers who improperly utilize the regulatory carve-out for RUO diagnostic devices.[3] However, after the issuance of that Agena Warning Letter last April, all had been quiet on the enforcement front in the RUO space and, given the priorities of the new administration, we expected it to remain that way. But surprisingly, last month, FDA posted yet another warning letter to DRG Instruments GmbH (“DRG”) alleging failure to qualify for the RUO carve-out (the “Warning Letter”), potentially signaling the Agency’s intention to increase, or at least maintain, oversight for RUO-labeled products.[4]Continue Reading What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

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

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

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