South Carolina lab pleads guilty in $6.8M kickback case; 1 in 4 dementia patients prescribed risky CNS drugs; FDA eases manufacturing rules for cell and gene therapies – Morning Medical Update

South Carolina lab pleads guilty in $6.8M kickback case

A South Carolina clinical laboratory and its founder have agreed to plead guilty and pay at least $6.8 million to resolve federal allegations of illegal kickbacks to physicians in exchange for laboratory referrals. Clinical Laboratory LTD Holding LLC, formerly Labtech Diagnostics, and CEO Joseph Labash, agreed to plead guilty to five counts of violating the Anti-Kickback Statute and to pay restitution, bringing total recoveries related to the company above $11.5 million, according to the U.S. Department of Justice (DOJ). Federal prosecutors said the payments were disguised as rent, phlebotomy and toxicology services, as well as free supplies and inflated equipment purchases, actions that allegedly compromised physicians’ independent medical judgment.

Risky CNS drugs commonly prescribed to dementia patients

One in four older Americans with dementia is prescribed central nervous system–active (CSN) drugs, including benzodiazepines, antipsychotics, sleep medications and anticholinergic antidepressants, despite longstanding safety warnings, according to a new JAMA study. Researchers from UCLA Health Sciences found that while overall use of these drugs declined among Medicare beneficiaries between 2013 and 2021, prescribing remained higher in patients with cognitive impairment and dementia, many without a clear clinical indication. The findings highlight persistent concerns about potentially inappropriate prescribing in a population particularly vulnerable to adverse drug effects.

FDA signals more flexibility for cell and gene therapies

The U.S. Food and Drug Administration (FDA) says it’s taking a more flexible approach to chemistry, manufacturing and control requirements for cell and gene therapies, aiming to speed development without weakening safety standards. In a news release, the agency said the approach is intended to help sponsors navigate product development and prepare for biologics license applications, reflecting lessons learned from approving nearly 50 cell and gene therapies over the past decade. Officials at the FDA’s Center for Biologics Evaluation and Research said clearer communication of these flexibilities should reduce uncertainty for developers while maintaining expectations for safety, purity and potency.