黑料不打烊

On June 22, the US Department of Health and Human Services (HHS) 听a department-wide initiative focused on 鈥渟trengthening American leadership in clinical research鈥� and addressing the increase in early-stage clinical research that is conducted abroad. In the announcement, HHS highlighted efforts across several agencies, including:听

• An FDA听听(RFI) on a proposed 鈥淓xpedited Investigational New Drug Pilot Program,鈥� which would establish a network of qualified research institutions (QRIs), to include academic medical centers, contract research organizations, regulatory advisors, and 鈥渙ther research or third-party review organizations,鈥� which would partner with drug sponsors to help develop and review clinical trial protocols for first-in-human (FIH) clinical trials intended for an Investigational New Drug (IND) submission to FDA. As a part of the model, QRIs would make recommendations to FDA, which the agency would review on a 鈥渞olling basis,鈥澨齬egarding听completed components of the submissions. HHS states that the pilot program would seek to shorten early clinical trial timelines by six to twelve months. The RFI is open until July 22;听
• 听from FDA clarifying it may be possible to听demonstrate听substantial evidence of effectiveness based on one adequate and well-controlled trial with results in other related听substudy听population(s) in the master protocol providing the confirmatory evidence;鈥�听
• An HHS Office of the Inspector General on certain regulations governing clinical trial participation;
• Support from NIH for informative clinical trials听leveraging听approaches that can efficiently move treatments to patients while听retaining听scientific rigor, accelerating development of therapies for patients with rare diseases, and improving enrolment in cancer studies;听
• ONC assessing ways to听leverage听electronic health records to connect patients with clinical trials; and听
• ARPA-H efforts to modernize clinical research, including through programs that听seek听to develop new ways to test multiple treatments and diseases at the same time, as well as leverage AI and machine learning for dosing, trial efficiency, and safety prediction.听

鈥疘n听an听听published by Fox News, Secretary Robert F. Kennedy, Jr. discussed the announcements, noting HHS interest in ongoing changes to support domestic clinical research, stating, 鈥淚f regulations, contracting requirements or institutional practices are slowing research without improving safety, we want to hear about them. We are prepared to challenge assumptions and remove barriers that no longer serve patients,听science听or the public interest.鈥�听

On June 18, the the US Food and Drug Administration鈥檚 (FDA鈥檚) Vaccines and Related Biologic Products Advisory Committee (VRBPAC) 听to assess Moderna鈥檚 mRNA-based influenza vaccine, mRNA-1010, or MFLUSIVA, for older adults. The committee unanimously voted to endorse FDA approval of both Moderna鈥檚 requests for traditional approval of MFLUSIVA in adults ages 50 to 64 years old and accelerated approval for adults 65 years and older. Specifically, the advisory committee voted 9鈥�0 that 鈥渢he benefits of听mFlusiva听outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age,鈥� and voted 9-0 that 鈥渢he benefits of听mFlusiva听outweigh its risks for the prevention of influenza disease in adults 65 years of age and older.鈥� This decision comes after FDA initially issued a听听letter in response to Moderna鈥檚 application, in which then-CBER Director Vinay Prasad cited inadequate trial design. Following a Type A meeting between Moderna and the Center for Biologics Evaluation and Research (CBER), Moderna听modified听the trial design, and FDA听听Moderna鈥檚 biologics license application (BLA) for review.听听

鈥疢oderna applied for traditional approval of the vaccine in adults 50 to 64 years old and accelerated approval for adults 65 years and older. The difference between the two approval pathways is that under accelerated approval effectiveness is evaluated based on a surrogate endpoint reasonably likely to predict clinical benefit which is then subject to post market confirmatory studies,听whereas听under the traditional pathway effectiveness must be听demonstrated听through clinical benefit. However, both approval pathways are FDA approvals and require substantial evidence of effectiveness for approval. Moderna agreed to conduct postmarketing studies to evaluate vaccine effectiveness for听MFlusiva听in the 65 and older population if granted accelerated approval.听

鈥疢oderna鈥檚 MFLUSIVA听represents听the first mRNA-based influenza vaccine, which could be particularly beneficial in avoiding certain challenges posed by traditional egg-based influenza vaccines, such as viral adaptations. FDA discussed the benefits of the vaccine鈥檚 mRNA base in its听, noting that it 鈥渟upports rapid strain reformulation in response to antigenic drift or shift,鈥� which could improve public health responses to new viral strains.听

鈥疶hough FDA is not听obligated听to follow VRBPAC recommendations, FDA approvals historically align with the committee鈥檚 recommendations. FDA鈥檚 current target date for a decision on Moderna鈥檚 application is August 5. Leavitt Partners will continue to听monitor for听updates.听

On June 15, FDA听听Colorado鈥檚 Section 804 Importation Program (SIP).听Colorado鈥檚 legislature passed听听directing the state鈥檚 Department of Health Care Policy and Financing (HCPF) to pursue the strategy in 2019, and the state initially听submitted a SIP application to FDA on December 5, 2022. Following several FDA-requested revisions and resubmissions by Colorado, FDA approved the most recent SIP, which was submitted by the state on December 4, 2025. FDA鈥檚 authorization of the plan comes under 听of the Food, Drug, and Cosmetic Act, Importation Program Policies and Authorizations, which听permits听states and tribes to import prescription drugs from Canada for cost-saving purposes. FDA authorized Colorado鈥檚 plan for a two-year period and outlined the requirements for foreign sellers, as defined in the Federal Code of Regulations under听.

Colorado is the second state to have an authorized SIP, joining Florida, whose program was 听in January 2024, and has since been extended four times. Colorado has published a听听of 20 prescription drugs to be imported in the program. These products span a wide range of prices and听uses. The U.S. pharmaceutical industry has expressed concern for public health and safety with the plan鈥檚 implementation. The industry鈥檚 backlash could pose a barrier to the program鈥檚 success, as Colorado needs pharmaceutical company buy-in to听maintain statewide prescription drugs access beyond the 20 products included in the importation program. Similarly, Canada 听importation of drugs from their country to the U.S. and is听monitoring听to ensure these efforts听don鈥檛听cause drug shortages for Canadians.听

On June 15, NIH听听the听creation of听the Office of Research Innovation, Validation, and Application (ORIVA) to accelerate the development and adoption of human-based research technologies and reduce reliance on animal models.听 will coordinate NIH-wide efforts to develop, validate, and scale New Approach Methodologies (NAMs), including 3D human tissue models, computational tools, and other animal-free methods that more accurately reflect human biology. The office will also serve as a hub for interagency coordination and regulatory translation, facilitating the broader scientific and regulatory acceptance of these emerging methodologies.

ORIVA is housed within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the NIH Office of the Director and will operate through two divisions: one focused on supporting the research community through new funding opportunities, research infrastructure, and training resources, and one tasked with coordinating a multi-agency effort to evaluate and advance the acceptance of new research methods. NIH Director Jay Bhattacharya and Deputy Director Nicole Kleinstreuer both noted that the office鈥檚 goal is to create systemic change and a foundational shift in biomedical research toward more human-relevant methods.