KY woman pleads guilty to selling unapproved drug to treat cancer, COVID-19
A Lexington woman pleaded guilty to introducing a drug called “Brightstar” for cancer and COVID-19 treatment, even after it was denied for use by the U.S. Food and Drug Administration.
Angela Henson pleaded guilty Aug. 22 to a federal misdemeanor of introduction of an unapproved new drug into commerce.
Prosecutors say she helped market the drug under false pretenses, calling it a “dietary supplement,” after the FDA denied the drug on grounds the company hadn’t proven its effectiveness.
From 2005 to 2024, Henson worked as the executive administrator for CBA Pharma in Lexington. She worked to achieve approval for an “investigational” new drug called “CBT-1.” The drug was intended to make chemotherapy cancer treatments more effective.
CBA Pharma submitted a new drug application for CBT-1 to the FDA in 2010. The government “refused to file” due to inadequacies in the application’s filing, according to court documents. The federal agency denied the application again in 2012 and 2013.
One of the major deficiencies was CBA Pharma failed to establish the drug’s efficacy for its intended use to enhance chemotherapy treatments. For more than a decade, CBA Pharma did not address any “shortcomings” outlined by the FDA and never completed another drug trial.
In February 2023, the FDA said it was going to withdraw the pending drug application. It was later discovered CBA Pharma was selling a product called “Brightstar,” which contained the same active ingredient as CBT-1.
CBA Pharma sold Brightstar as a “dietary supplement,” rather than a drug, court documents state. The company sold bottles of Brightstar capsules through internet orders for $625.
Henson was a primary point of contact for customers who purchased Brightstar and personally packaged and shipped bottled in Kentucky and out of state. The Lexington woman told customers the drug was used to treat cancer and COVID-19, and provided direction on the dosage customers should take, according to the plea agreement.
She faces a maximum of one year in prison and a fine of no more than $100,000. She could receive supervised release for a year. Henson has agreed to cooperate with the investigation and prosecution of other individuals, including testifying in other proceedings.
The FBI announced it was investigating CBA Pharma in February 2024. The company is no longer operating at its former Perimeter Drive location in Lexington.
Her sentencing is scheduled for Dec. 29.
