RA/QA News Roll: Mid February 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
These RA/QA news rolls are available in full only to paid subscribers. Upgrade here.
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 Leadership and Administration
HHS leadership shake-up elevates FDA officials — Secretary Robert F. Kennedy Jr. announced Chris Klomp as chief counselor to “oversee all operations of the Department,” including FDA, while appointing FDA’s Kyle Diamantas (food leader) and Grace Graham (legislative and policy leader) as senior counselors serving in addition to their existing roles. POLITICO reports Deputy Secretary Jim O’Neill and General Counsel Mike Stuart are leaving their positions as part of the reorganization.
Makary faces mounting criticism for “incompetence” and “poor stewardship” 💊 — Rep. Jake Auchincloss called for Commissioner Makary to testify before the House Energy and Commerce Subcommittee on Health, stating “his incompetence and poor stewardship of the Food and Drug Administration is undermining the world’s gold standard biomedical regulator.” Auchincloss alleged public trust in the FDA’s safety and efficacy standards is “collapsing.”
White House overrules FDA on CNPV selection 💊 — STAT News reports psilocybin treatment from Compass Pathways made the FDA’s priority voucher list, but HHS and White House “shot it down” just hours before the agency announced vouchers, suggesting an additional political interference layer in the Commissioner’s National Priority Voucher program.
Deputy Chief of Staff under HHS investigation — Bloomberg reports Samuel Doran under investigation by HHS Office of Inspector General for potentially misleading the government “by using a sham divorce to avoid running afoul of conflict-of-interest rules.” Doran, described as a key Makary ally appearing on panels and CEO meetings, marking the second major Makary hire under investigation following George Tidmarsh.
Hawley loses confidence in Makary over mifepristone review timeline 💊 — Sen. Josh Hawley told Semafor he is “fuming” after a meeting revealed mifepristone safety study could take years, stating “I think that this safety study is a dead end” and “I frankly can’t tell” if FDA is proceeding at all. HELP Committee Chair Bill Cassidy called the lack of progress “disappointing.”
FDA General
Give Kids a Chance Act becomes law 💊 — The House passed the Consolidated Appropriations Act 2026 by 217-214 margin, including Mikaela Naylon Give Kids a Chance Act with FDA reforms: reauthorizing Rare Pediatric Disease Priority Review Voucher program, imposing new pediatric oncology testing requirements, closing orphan drug exclusivity “loophole,” facilitating generic drug development, and requiring new foreign office establishment.
CNPV program faces continued scrutiny and modifications 💊 — Rep. Auchincloss raised concerns about program authority since Congress didn’t explicitly grant it, and FDA’s Office of Chief Counsel wasn’t consulted.
QMSR launches, replacing decades-old quality system 💉 — The Quality Management System Regulation went into effect on February 2, superseding the Quality System Regulations after a years-long transition. CDRH began updating guidance documents to align with the new regulation, removing 820 regulation references and replacing them with ISO 13485 citations, affecting cybersecurity, software assurance, and submission templates.
Moderna refusal-to-file exposes vaccine review inconsistencies 💊 — The FDA refused to file Moderna’s mRNA-1010 influenza vaccine application despite the company using a Priority Review Voucher, with CBER reviewers favoring review but Director Vinay Prasad overruling staff. The agency cited an inadequate comparator not reflecting “best-available standard of care,” though Moderna claims regulations don’t reference such a standard.
CAR-T development faces a new safety monitoring approach 💊 — CBER leadership published an Annals of Internal Medicine piece outlining a case-by-case approach for autoimmune disease applications, particular sensitivity for pediatric patients, and careful consideration of fertility given reproductive-age patient populations, with long-term follow-up studies standard.
Makary misstates agency performance metrics 💊 — The Commissioner claimed 100% target date performance on “13th & Park” podcast, but the CDER annual report confirms 96% rate with KalVista’s Ekterly and Akeso’s penpulimab-kcqx missing deadlines. The rate aligns with the 89-98% historical range since 2021, contradicting the “first time in history” claim.
Continued staff losses despite hiring promises 💊💉 — First quarter FY2026 data shows net loss of 65 CDER employees and 27 CBER employees under user fee programs, following 3,900 total FDA staff losses in FY2025. BIO CEO John Crowley testified losses create “increasing instability,” while PhRMA’s Lori Reilly warned of “far-reaching economic impacts.”
FDA requiring “humility” from companies for favorable reviews 💊 — A senior FDA official told media Moderna could potentially get approval if they “show some humility and say, ‘Yes, we didn’t follow your recommendation’” regarding refused influenza vaccine filing, marking an unprecedented link between company attitude and regulatory review decisions.
