FDA moves to speed up drug development; flu shot gaps in the ED; nurse practitioner sentenced for $12M Medicare fraud — Morning Medical Update

FDA moves to speed up drug development

A new HHS initiative aims to shorten trial timelines and bring more early-stage research back to the United States.

The U.S. Food and Drug Administration (FDA) on Monday announced a series of measures meant to speed up drug development from early investigational studies through late-stage trials, part of a broader Department of Health and Human Services (HHS) effort the agency is calling Operation TrialBlazer. The FDA said it is planning a pilot program that would pair drug sponsors with research institutions such as academic medical centers and contract research organizations to shorten the time from drug identification to first-in-human studies.

It also updated guidance for early-stage studies, saying a more phase-appropriate approach could save companies six to 12 months of development time. In late-stage development, the agency said drugmakers may be able to rely on one rigorous, well-controlled pivotal trial plus confirmatory evidence, rather than multiple pivotal studies, to support approval. HHS officials framed the changes as a way to reverse a shift of early-stage clinical research overseas and keep more drug development in the United States.

Most emergency department patients are behind on flu shots

A national study points to emergency departments as a missed chance to vaccinate underserved patients.

Most adults treated in U.S. emergency departments (EDs) are not up to date on their flu vaccine, according to a University of California, Riverside-led study published in the Journal of Emergency Medicine. Surveying 3,285 adult patients at 10 emergency departments across eight cities, researchers found that while 96% had heard of the flu vaccine, 58.4% had not received one in the past year. Patients without a primary care physician were more than twice as likely to be behind, and lower vaccination rates were also seen among uninsured and African American patients. Among those not up to date, 37% said they would accept a flu shot if it were offered during their visit.

“Emergency departments are often the only point of contact with the health care system for many patients,” said coauthor Rajesh Gulati, M.D. The authors say EDs are an underused setting for vaccination that could help reach medically underserved patients.

Nurse practitioner sentenced to 87 months in $12M Medicare fraud

Prosecutors said she ordered medically unnecessary cancer genetic tests in exchange for kickbacks, some after phone calls lasting under 30 seconds.

Scharmaine Lawson Baker, 59, of Fulshear, Texas, was sentenced to 87 months in prison and three years of supervised release for causing more than $12 million in false claims to Medicare for medically unnecessary cancer genetic tests. According to the Department of Justice, the licensed nurse practitioner received tens of thousands of dollars in kickbacks for ordering the tests while working as an independent contractor for a telehealth company from October 2018 to October 2019.

Prosecutors said she signed hundreds of orders after phone calls that typically lasted less than 30 seconds and without examining the patients, at times ordering ovarian and cervical cancer tests for male patients. She never reviewed the test results, including when they showed patients had variants predisposing them to certain cancers. A federal jury convicted her of six counts of health care fraud in July 2025. She was also ordered to pay more than $1.5 million in restitution.