RFK Jr. Children's Health Defense, NIH grants: Morning Rounds

• The World Health Organization reported on September 10 that the Democratic Republic of the Congo is experiencing the fastest-growing Ebola outbreak on record. • Health officials have confirmed more than 6,700 cases and more than 3,200 deaths during this current surge.

• Xenon Pharmaceuticals paused new patient enrollment in clinical trials for its experimental major and bipolar depression drug on Thursday. • The company halted the studies following reports of side effects related to the mental and nervous system.

• Philadelphia health officials reported a potential measles exposure at the Children's Hospital of Philadelphia on September 11. • The exposure occurred in the neonatal intensive care unit and other locations at the hospital's 3401 Civic Center Blvd facility.

• The U.S. Food and Drug Administration approved this season's COVID vaccines nearly three weeks ago for general use. • Children with private insurance can currently access the shots, but those in the Vaccines for Children program must wait for Health and Human Services sign-off.

• The FDA has allowed companies to sell drugs and devices while completing safety and efficacy studies, but many of these postmarket requirements are now overdue or behind schedule. • FDA leaders announced in February that the default requirement for agency approvals will shift to one clinical trial instead of two.

• An analysis of FDA data revealed that hundreds of required postmarket studies for drugs and medical devices are running behind schedule. • The findings indicate that many manufacturers have failed to complete follow-up research mandated by the agency years after product approval.

• The FDA has allowed many pharmaceutical companies to delay or ignore required safety and efficacy studies for drugs and devices already on the market. • Agency records show that these "postmarket" studies, intended to verify a product's performance after approval, are frequently behind schedule or overdue.

• Lawmakers and advocates are calling on the Trump administration to release over $1 billion in congressionally approved global health funding. • An analysis by Partners in Health shows the Office of Management and Budget is withholding $1.35 billion in bilateral funds.

• Montana is granting the biotech industry broad authority to sell unapproved drugs, allowing patients to access experimental treatments regardless of federal regulations. • The state's move bypasses the standard FDA process, which typically requires three phases of clinical trials to assess efficacy, dosage, and adverse events.

• South Korea is expanding its research and development support program from five to all nine regional national university hospitals, with a second phase beginning in 2028. • The program funds advanced medical research including genomic big data analysis and whole-exome sequencing, which identifies mutations across all protein-coding regions of the genome.

• The FDA continues to face operational challenges and hiring freezes resulting from budget cuts implemented by the Department of Government Efficiency (DOGE). • These cuts have stymied the agency's ability to fill critical roles and maintain standard staffing levels.