News
Article
Author(s):
Within the past week, news has emerged from the Trump administration, from the HHS secretary confirmation hearings to retracted FDA guidelines on diversity in clinical trials.
During his confirmation hearing before the Senate Finance Committee, Robert F. Kennedy Jr, nominee for HHS secretary, faced scrutiny over his health care policy positions, particularly regarding Medicare and Medicaid. Sen Bill Cassidy (R, Louisiana) pressed Kennedy on his plans for reforming Medicaid and integrating care for dual-eligible individuals, to which Kennedy acknowledged systemic issues but admitted he lacked a concrete strategy. While advocating for transparency, value-based care, and innovations like telemedicine, Kennedy criticized Medicaid's inefficiencies but stopped short of proposing major cuts. Sen Maggie Hassan (D, New Hampshire) defended Medicaid's role in supporting vulnerable populations while Sen. Mark Warner (D, Virginia) challenged Kennedy over his campaign’s fundraising email linked to the Trump administration's now-reversed federal funding freeze. Kennedy also addressed broader health concerns, including chronic disease and industry transparency, while facing bipartisan scrutiny over his past vaccine-related statements.
The FDA’s removal of draft guidance on diversity in clinical trials, following President Donald Trump’s executive order restricting diversity, equity, and inclusion (DEI) programs and federal recognition of gender identity, has sparked concern about the agency’s stance on clinical trial diversity requirements. The deleted guidance, initially released in June 2024, outlined Diversity Action Plans aimed at improving representation in clinical studies, detailing enrollment goals by race, ethnicity, sex, and age. With the statutory deadline for final guidance approaching in June 2025, sponsors now face uncertainty regarding compliance expectations. The move raises broader concerns about the administration’s commitment to diversity in clinical research, particularly given historical disparities in trial participation. Industry stakeholders and policy makers now await clarification on whether the FDA will uphold its prior commitments or further shift regulatory priorities.
The FDA has approved suzetrigine (Journavx; Vertex Pharmaceuticals), a first-in-class, nonopioid NaV1.8 pain signal inhibitor, for treating moderate to severe acute pain in adults. This marks the first new acute pain treatment in over 20 years and comes amid the ongoing opioid crisis, highlighting the need for alternatives to traditional opioid medications. Backed by multiple clinical trials, suzetrigine demonstrated significant pain reduction in postsurgical patients, though its efficacy in other pain conditions remains uncertain. Analysts see its approval as a potential shift in acute pain management, with an Institute for Clinical and Economic Review analysis suggesting cost savings compared with opioids. However, long-term safety concerns warrant continued postmarket monitoring.
Camden Coalition has launched a new skills lab featuring 12 microlessons designed to provide actionable strategies for professionals working in complex care. In this interview, Gladys Antelo-Allen, associate director of education and training, highlights how the training focuses on key areas such as building authentic healing relationships, a foundational concept explored through 3 dedicated lessons. The lab offers flexible, accessible learning through role-play videos and on-the-go resources, allowing users to engage with critical aspects of complex care in under 10 minutes per lesson. By structuring the content into 8 key topics, the program enables deeper exploration of essential skills that can be immediately applied in practice.
At an Institute for Value-Based Medicine® event in Dallas, leading experts from The University of Texas Southwestern Medical Center, Texas Oncology, and other institutions discussed breakthroughs in cancer treatment and care delivery. Panels covered advancements such as CDK 4/6 inhibitors and genomic integration in breast cancer, precision medicine in lung cancer, and access challenges in hematology. Experts highlighted the role of real-world data, evolving treatment strategies, and the shift toward value-based oncology care. A central theme throughout the discussions was the need to balance innovation with patient-centered, equitable, and sustainable health care models.