RA/QA News Roll: Late December 2024
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.
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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 Biden administration has published its final Unified Agenda, which outlines the regulations that each federal agency plans to release in the coming year and beyond. However, with the incoming Trump administration, it is highly unlikely that these regulations will be released as scheduled or in some cases, at all.
Rep. Buddy Carter (R-Ga.) will become the new chair of the Energy and Commerce Committee’s Subcommittee on Health, with Rep. Neal Dunn (R-Fla.) appointed as vice chair. The E&C Health Subcommittee is the primary committee in the House of Representatives responsible for overseeing the FDA. Previously, the subcommittee was led by Rep. Brett Guthrie (R-Ky.), who has been elected to lead the full Energy and Commerce Committee following the pending retirement of Rep. Cathy McMorris Rodgers (R-Wash.).
A new report from the advocacy group Public Citizen calls Jim O’Neill, President-elect Donald Trump’s intended nominee for deputy secretary of the Department of Health and Human Services, "unfit" for the position. The report highlights several of O’Neill's past statements regarding the FDA, including his opposition to the agency’s regulation of diagnostic algorithms and his belief that the FDA should not regulate certain drugs before they are marketed.
STAT News has published an analysis looking at Marty Makary, Trump’s intended nominee to run the FDA and his past statements on public health. Many of these statements were contrarian, raising concerns among some public health officials about how Makary will manage the FDA and its thousands of medical scientists.
FDA Guidances, Regulations, and Related Documents
The FDA’s Office of Pharmaceutical Quality (OPQ) has published a revised Manual of Policies and Procedures (MAPP) focused on how it handles “Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes.” As with many of OPQ’s MAPPs, this update reflects organizational changes made to OPQ earlier this year. 💊
The FDA has published a blog post reflecting on the third anniversary of the foundation of the "Generic Drug Cluster," which was established by the FDA and six other global regulators. While generic drug regulations are generally less harmonized globally compared to those for new drugs, some fundamental regulatory questions are consistent across regions, such as how to demonstrate bioequivalence. The blog post provides a summary-level overview of some of the efforts and activities of the cluster. 💊
The FDA has issued a new batch of courtesy letters to the makers of prospective dietary supplement products. These letters typically indicate issues with the proposed indications of use, warning that marketing the products in this manner would violate federal law. 💊
FDA General
FDA Principal Deputy Commissioner Namandjé Bumpus is set to depart the FDA, according to an email sent by Commissioner Robert Califf to FDA staff. Bumpus’ departure comes as a surprise, given that she held a career appointee position. However, pending changes to the U.S. Civil Service by President-elect Donald Trump, known as the "Schedule F" reforms, could have put her position in jeopardy. One key question remains: Will Califf seek to fill Bumpus' position with a new career official before the start of the Trump administration, or will Marty Makary, Trump’s pick to be the next FDA commissioner, have the opportunity to appoint a new principal deputy commissioner?
The FDA has approved reorganizing the CDER’s Office of Medical Policy (OMP) to "modernize clinical trials." This reorganization focuses on handling policy topics such as artificial intelligence, digital health technologies, and real-world evidence. As part of the changes, OMP’s Division of Clinical Trial Quality has been renamed the Division of Clinical Innovations. 💊
MedTech Dive recently interviewed Nastassia Tamari, director of CDRH’s Division of Medical Device Cybersecurity. In the interview, Tamari shares her insights on CDRH’s new cybersecurity authority, software bills of materials, and other related topics. 💉
The FDA has updated its webpage to explain how the CDRH Total Product Life Cycle Advisory Program (TAP) advises the industry by collaborating with non-FDA parties, such as patients or experts in clinical evidence development and reimbursement. The FDA maintains a list of non-FDA parties that have agreed to provide TAP participants with strategic input on their innovative devices. 💉