RA/QA News Roll: Late January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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Alright, back to our regularly-scheduled programming.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA and the Administration Transition
The Senate Finance Committee advanced Robert F. Kennedy Jr.'s nomination for Secretary of Health and Human Services on Tuesday with a 14-13 party-line vote. The decision follows two contentious hearings last week, which left his confirmation prospects uncertain. While most Republicans on the committee were expected to support Kennedy, Sen. Bill Cassidy (R-La.), a medical doctor, had expressed reservations about the nomination, citing concerns that Kennedy’s past statements questioning vaccines could undermine public confidence in immunization programs. Cassidy, who is up for reelection in 2026, said last week that he was "struggling" with the decision. He spoke with Kennedy on Sunday, though he did not initially disclose his voting intentions. Ultimately, Cassidy voted in favor of advancing the nomination on Tuesday.
President Donald Trump has reformed the President’s Council of Advisors on Science and Technology (PCAST) after disbanding it earlier this week. PCAST advises the White House on science and technology policy and has historically addressed FDA regulatory topics in some of its reports. The newly reformed PCAST is being co-led by the administration’s “Crypto Czar” and includes a mission focused on “advancing emerging technologies” by developing both regulatory and non-regulatory frameworks in areas such as biotechnology, aiming to balance innovation and safety.
During a confirmation hearing before the Senate Finance Committee, Robert F. Kennedy Jr. stated that he is committed to finalizing the FDA’s Diversity Action Plan guidance document, which was released in draft form last year.
The commitment came in response to a question from Sen. Ben Ray Luján (D-N.M.), who asked: “Will you commit to finalizing the congressionally mandated FDA guidance to increase, increasing clinical trial diversity?” Kennedy responded: “Yes.” The FDA recently removed the draft guidance from its website.
The FDA has issued a Federal Register notice announcing a change to the implementation date for its recent testing recommendations on the risk of transmitting tuberculosis and agents that cause sepsis in human cells, tissues, and tissue-based products. Originally, the guidance documents required implementation within four weeks, but the agency has now extended the deadline to May 4, 2025. According to the FDA, the delay is due to the regulatory freeze imposed during the Trump administration and the need for additional stakeholder feedback. Notably, the notice is signed by Dorothy Fink, the acting secretary of HHS, rather than the FDA’s policy staff or Acting Commissioner Sara Brenner. 💊
A LinkedIn post by Sarah Moeller, co-chair of the AAMI BE/WG04 Clinical Investigations Working Group, states that the FDA is temporarily withdrawing from its international standards development work, citing the Trump administration’s communications freeze. Moeller wrote: “We were just informed that FDA will not be communicating with us or participating on work that is in progress, including critical standards related to medical device studies including ISO18969 (Clinical evaluation of medical devices).” While the FDA’s withdrawal appears to be linked to the federal communications freeze and may be temporary, the agency’s ongoing role in standards development and international harmonization efforts remains uncertain as the administration pursues its priorities, including reducing the federal workforce and disengaging from international governmental groups. 💉
A memo from the Office of Personnel Management (OPM) directs federal agencies to take a series of actions related to gender policies. The memo instructs agencies to “take down all outward-facing media […] that inculcate or promote gender ideology,” revise all agency forms to list only “male or female” rather than gender identity, “disband or cancel any employee resource groups” promoting gender ideology, and “withdraw any final or pending documents, directives, orders, regulations, materials, forms, communications, statements, and plans that inculcate or promote gender ideology.” As part of these directives, the FDA recently withdrew a guidance document focused on evaluating sex- and gender-specific data in medical device clinical studies.
Steven Grossman provides an analysis of lessons for the FDA based on the actions of the first Trump administration, now that President Donald Trump has returned to the White House. One key takeaway he highlights is the initial uncertainty surrounding executive orders and directives. Grossman writes: “From watching OMB and FDA interpret these types of executive orders and directives in 2017, I learned there is a lack of clarity when they are first announced. Whether and how much FDA would be affected requires reading the fine print—in the overall declaration and then how it is to be applied to the massive responsibilities, different personnel systems, multiple funding sources, and wide range of skills needed at FDA.”
FDA Guidances, Regulations, and Related Documents
Two Paperwork Reduction Act notices are scheduled for publication in the Federal Register on Feb. 3, addressing the biosimilars user fee program and prescription drug labeling. While neither notice is particularly notable on its own, they mark only the second and third Federal Register notices posted by the FDA during the Trump administration. These are also the first notices to bear the signature of P. Ritu Nalubola, the FDA’s new acting deputy commissioner for policy, legislation, and international affairs. 💊
The FDA has issued a medical device correction notice concerning Nova Biomedical’s StatStrip Glucose and Glucose/Ketone Hospital Meters. According to the FDA, these devices could potentially provide incorrect results for patients. A software update to resolve this issue has been released to users, but the FDA indicates that some facilities may not have applied the update yet. 💉
The International Medical Device Regulators Forum (IMDRF), a regulatory harmonization group that includes the FDA as a member, has released a new technical document outlining good machine learning practices for medical device development. In addition, the group has published a second technical document focused on characterizing software-specific risks in medical device software. 💉
A new report details the 2024 activities and accomplishments of the FDA’s CBER. The report, authored by CBER Director Peter Marks, highlights the center’s key initiatives, regulatory advancements, and policy developments over the past year. 💊
The FDA released its Information Technology Operating Plan just before the end of the Biden administration. The 114-page document, featuring a foreword from Chief Information Officer Vid Desai, provides an overview of the agency's IT challenges and outlines its strategies for addressing them.
FDA General
Sara Brenner has been named acting commissioner of the FDA. POLITICO previously reported that she was in contention for the role, and late yesterday, she was appointed principal deputy commissioner and “First Assistant to the Commissioner of Food and Drugs.” This designation was a necessary step under the Federal Vacancies Reform Act to allow her to assume the acting commissioner role. Brenner has been with the FDA since September 2019, serving as associate director for medical affairs and chief medical officer for in vitro diagnostics. Before joining the agency, she was a senior policy advisor on health and biomedical innovation at the White House during the first Trump administration.
Troz Tazbaz, the FDA’s top digital health official, is leaving the agency after two years as director of the Digital Health Center of Excellence (DHCoE). During his tenure, Tazbaz oversaw implementing the agency’s work on digital health technologies (DHTs), novel digital products, and the Predetermined Change Control Plan (PCCP) policy. He also initiated and led efforts in emerging areas, including the oversight and review of generative artificial intelligence (AI) technologies. The FDA has not yet announced a successor, but longtime digital health regulators Anindita (Annie) Saha, Sonja Fulmer, and Matthew Diamond are potential candidates to serve in an acting capacity. Tazbaz was the DHCoE’s second director since its establishment in 2020. Bakul Patel initially led the office until his departure in 2022, followed by former regulator and diagnostics/digital health expert Brendan O’Leary, who served as acting director until Tazbaz took over.
The FDA’s Oncology Center of Excellence (OCE) has eliminated its Equity Program, with the program’s webpage deleted. The removal appears to align with the White House’s directive yesterday to halt all DEI-related webpages and initiatives. The webpage stated that the program’s goal was to “develop and promote policies to ensure adequate enrollment of historically underrepresented and vulnerable subgroups in oncology clinical trials intended to support FDA approval to evaluate any differences that may exist across the population.”
The FDA has approved Vertex Pharmaceuticals’ Journavx (suzetrigine), a new non-opioid treatment for moderate to severe acute pain. The approval is significant for two reasons: it marks the introduction of a first-in-class pain management drug, and it is the first time since the Trump administration that the FDA has publicly announced such an approval. In its announcement, the FDA highlighted its efforts to facilitate the approval process, citing a February 2022 draft guidance document on the development of non-opioid analgesics. 💊
The FDA has issued a warning regarding a cybersecurity vulnerability in Contec and Epsimed’s patient monitors. This issue could allow unauthorized users to remotely control the devices or cause them to malfunction. The software that manages these monitors contains a backdoor, which implies that the device or its connected network might have been, or could potentially be, compromised. 💉
The FDA’s final rule on Nonprescription Drug Products with an Additional Condition for Nonprescription Use (ACNU), initially set to take effect on Jan. 27, 2025, has been delayed until March 21, 2025, due to President Trump’s recent regulatory freeze. The Federal Register notice, signed by HHS Acting Secretary Dorothy Fink, is the only regulatory notice issued by the FDA since Trump took office. 💊