RA/QA News Roll: Mid January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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.
If you haven’t upgraded to a paid subscription yet, you can do so here. Also, make sure to follow us on LinkedIn and catch the latest episodes of our podcast, The Life Science Rundown.
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 New York Times has reported on potential conflicts of interest involving Vivek Ramaswamy, co-lead of the Department of Government Efficiency (DOGE). Central to these concerns is Ramaswamy's significant investment in biotechnology companies he founded, including Roivant, where he remains one of the largest shareholders. Roivant currently has a market valuation of $8 billion. The Times highlights a specific scenario: if Ramaswamy were to advocate for faster drug approvals through DOGE, it could benefit Roivant, which is developing drugs that might seek approval during a potential second term for President Trump. Expedited approvals would increase the value of Roivant and, by extension, Ramaswamy's stake in the company.
BioCentury reports that John Crowley of the Biotechnology Innovation Organization is expected to advise President-elect Donald Trump on FDA reforms. Crowley is anticipated to join an advisory body that will make recommendations on modernizing the agency. Details on whether the advisory body will have a formal structure remain unclear.
POLITICO reports that Heather Flick has been chosen as the next HHS chief of staff, set to serve under Robert F. Kennedy Jr., pending his Senate confirmation. Flick is expected to play a key role in managing HHS operations and will likely serve as the primary point of contact for contentious issues such as abortion pills, flavored tobacco products, and laboratory-developed tests, according to former senior FDA official Marc Scheineson.
A group of 15,000 doctors has signed an open letter urging Senators to reject the confirmation of Robert F. Kennedy Jr. as the next secretary of HHS. The letter describes Kennedy as “unqualified” and “actively dangerous,” citing concerns over his suitability for the role.
STAT News reports that the Trump administration's FDA transition team is beginning to take shape. Lowell Zeta, a former senior counselor to ex-FDA Commissioner Stephen Hahn and now with the law firm Hogan Lovells, is serving in a key role. These transition teams play a critical part in selecting candidates for politically appointed and open positions within the agency. Additionally, Grace Graham, who most recently served as the chief health counsel for the House Energy and Commerce Committee, is reportedly being considered for a senior post at the FDA.
FDA Guidances, Regulations, and Related Documents
The FDA has provided Congress with a status update report on Diversity Plans submitted to the agency in fiscal years 2023 and 2024 following the passage of the Food and Drug Omnibus Reform Act. The report notes an increase in submissions, with 206 Diversity Plans received in FY2024, up from 139 in FY2023. While the submission of Diversity Action Plans is not yet mandatory—pending the finalization of FDA guidance—the agency acknowledged that these voluntary submissions demonstrate companies are taking proactive steps to address diversity in clinical trials.
On January 7, the FDA released dozens of significant guidance documents. We covered them here:
The CBER issued new guidance with recommendations to reduce the risk of transfusion-transmitted malaria. The guidance aligns conceptually with several others released by the FDA last week. 💊
The FDA has submitted a report to Congress addressing the backlog of postmarketing requirements (PMRs) and commitments (PMCs) tied to the agency's accelerated approval program. As of December 31, 2024, there were 1,636 unfulfilled PMRs and PMCs. The report categorizes these studies by status, including pending, ongoing, submitted, delayed, or terminated. We broke it down on LinkedIn. 💊
The FDA has published a webpage detailing its efforts to establish acceptable intake (AI) limits for N-nitrosamine impurities in drugs. Nitrosamines, a class of chemicals that can form during drug manufacturing, include known and probable carcinogens. While they naturally occur in some cooked foods, regulators aim to determine acceptable limits specific to each chemical. The webpage describes a new methodology developed by the FDA and international regulators called the Carcinogenic Potency Categorization Approach (CPCA). This method uses the chemical structure of a nitrosamine impurity to assign it to one of five potency categories, each reflecting a different level of carcinogenic risk, to recommend AI limits. 💊
CDER released a revised Manual of Policies and Procedures (MAPP) outlining how it handles emergency clinical trial applications for compassionate use received outside of normal working hours. This marks the first update to the MAPP since 2018 and incorporates new workflows, procedures, and best practices, as detailed in the document. 💊
CDER released a report detailing drug approvals in 2024. Highlights include a record-setting year for biosimilar approvals, with 18 new biosimilars, representing nearly a third of the 60 biosimilars CDER has approved to date. Additionally, 68% of drug products were approved first in the U.S., and 37 out of 50 products were approved during their first review cycle. 💊
The FDA has released a revised draft guidance on developing drugs and biologics for weight reduction, updating its previous guidance from 2007, which was widely considered outdated. The new 24-page document provides detailed recommendations on clinical trial design considerations for companies aiming to develop treatments for weight loss conditions. It reflects current scientific and regulatory advancements in the field. 💊
CBER released its new guidance agenda, outlining the guidance documents under development for the year. The agenda includes 21 planned guidances, with three being newly introduced. As the agency’s division for biologics and blood products, CBER’s agenda provides a roadmap for upcoming regulatory priorities and developments in the field. 💊
CBER issued a revised Standard Operating Policy and Procedure (SOPP) addressing the Processing and Review of Trans-BLA Submissions. This SOPP covers the handling of multiple BLAs submitted as a single package for identical changes. The latest revision includes a clarification on how regulatory project managers should verify documentation related to Submission Tracking Numbers for the BLAs to ensure proper tracking and processing. 💊
FDA General
Patrizia Cavazzoni, director of the FDA’s CDER, will retire from the agency on January 18, 2025. In a statement, Cavazzoni expressed her desire to spend more time with her family, acknowledging that they had “taken the backseat over the past few years due to the demands of my role and our critically important public health work.” The FDA has not yet announced an acting director for CDER, but Jacqueline Corrigan-Curay, the current principal deputy center director, is considered the most likely candidate. 💊
The FDA, in collaboration with the Partnership for DSCSA Governance (PDG), will host a series of webinars on implementing the Drug Supply Chain Security Act (DSCSA) in 2025. Each of the three webinars is scheduled two months before the expiration of a specific exemption for trading partners established by the FDA in November 2024. 💊
The FDA has issued a Federal Register notice proposing to refuse approval of Vanda Pharmaceuticals' new drug application for Tradipitant capsules, an investigational treatment for nausea symptoms in gastroparesis. The notice grants Vanda the opportunity to request a public hearing on the proposal. 💊
The FDA will offer an upcoming training course on biosafety laboratory containment, emphasizing "achieving data quality and integrity" in BSL-4 labs. These facilities house the most dangerous pathogens and operate under the strictest safety and security protocols. 💊
The FDA’s Office of the Chief Scientist has released an updated guidance agenda, including two life sciences-related guidances planned for next year. The first will address “Conflicts of Interest and Eligibility for Participation in FDA Advisory Committees,” while the second will cover “Appearance Concerns and Authorizations for Participation in FDA Advisory Committees.”
A new report from the HHS Office of Inspector General raises concerns about three drug products granted accelerated approval by the FDA: Aduhelm (aducanumab), eteplirsen, and hydroxyprogesterone caproate. While much of the report reiterates longstanding critiques of the agency's use of accelerated approval in some cases, it includes notable details, such as the revelation that “some meetings with the sponsor appeared to be missing from the administrative file” for Aduhelm. The report also offers several recommendations for the FDA, including that the Accelerated Approval Council establish defined factors for advising on certain drug applications. However, the FDA disagreed with this recommendation, deeming it “inefficient.” 💊
CDRH has announced an update to its Recognized Consensus Standards Database, adding 71 new and revised standards. Notably, the update includes four standards related to device sterility, reflecting ongoing industry efforts to move away from using ethylene oxide (EtO) as a sterilizing agent due to environmental concerns. 💉
The FDA has announced a webinar focusing on investigational use requirements for in vitro diagnostics and laboratory-developed tests. The session will cover the IDE Regulation (21 CFR Part 812) and its regulatory requirements for studying investigational devices. The webinar will also provide an overview of the FDA’s typical review process for IDE applications. 💉
The FDA has issued a contract notice seeking information on the market capabilities of Artificial Intelligence-powered Extended Reality (XR) tools, including Augmented Reality (AR) and Virtual Reality (VR) training platforms. The agency aims to explore how these technologies could provide next-generation immersive learning, experiential training, and microlearning opportunities for its regulatory inspection and investigation workforce. 💉
Governing
A bipartisan group of House legislators has issued a press release urging the Department of Commerce to update its regulations to require a license for engaging with Chinese military hospitals in clinical trials. The lawmakers emphasize the need for stricter oversight to address national security and ethical concerns surrounding such collaborations. 💊
Sen. Bill Cassidy (R-La.) has officially assumed the role of chair for the Senate Health, Education, Labor, and Pensions (HELP) Committee in the new Congress. The HELP Committee is primarily responsible for overseeing the FDA, apart from its appropriated budget. Meanwhile, Sen. Susan Collins (R-Maine) has taken over as chair of the Senate Appropriations Committee.
Rep. David Schweikert (R-Ariz.) has introduced new legislation proposing amendments to FDA authority to clarify that “artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administration.” This bill appears to be a reintroduced version of the Healthy Technology Act of 2023, which similarly sought to enable AI or machine learning technologies to prescribe drugs, provided such activities were permitted under state law. 💊
Compliance and Enforcement
The FDA issued a jaw-dropping warning letter to a Canadian manufacturer claiming (among many other issues) that the Quality Manager shoved and shouted at investigators in the laboratory. Lab staff, under the manager’s direction, refused to open a drug stability chamber. The manager repeatedly prevented investigators from speaking directly with other staff members, insisting that only he could answer questions. This interference extended to basic operational queries about temperature monitoring and product specifications. 💊
The FDA has issued a new batch of Warning Letters to medical device companies, including Hologic, Integra LifeSciences, Xoran Technologies, Randox Laboratories, and Phillips Precision. 💉