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Another American healthcare founder guilty of offences.

Monday, 2 September, 2024 - 04:54

The USA's Food and Drugs Administration has prosecuted "John W. Kosolcharoen, 53, most recently of Orange County, California" for introducing an unapproved new drug into interstate commerce with the intent to defraud and mislead.

Kosolcharoen has pleaded guilty and if he is jailed he won't have to go far - he's already in jail following a conviction on unrelated charges. He will be sentenced in late September.

Kosolcharoen 's LinkedIn profile, today, says "Experienced CEO with a demonstrated history of working in the biotechnology industry. Skilled in Negotiation, Cash Flow, Leveraged Finance, Asset Management, and Benefits Realization. Strong business development professional with a Bachelor of Business Administration (BBA) focused in Banking, Corporate, Finance, and Securities Law from University of Wisconsin-Madison. " He has 500+ connections, a clutch of strong recommendations and has uploaded a document, which remains live, about his product. There is nothing about being in jail.

LiveOn is described as "the future of regenerative medicine" Its website is liveyon.com. It doesn't work.

According to court documents, beginning in 2016, Kosolcharoen created two companies, Liveyon LLC and Genetech Inc., to manufacture and distribute injectable stem cell products made from human umbilical cord blood. Liveyon marketed the products under different brand names, including “ReGen.” In pleading guilty, Kosolcharoen admitted that he and others misrepresented ReGen as suitable for the treatment of a variety of conditions, such as lung and heart diseases, autoimmune disorders, Alzheimer’s disease, Parkinson’s disease and others. Liveyon marketed the products throughout the United States until about April 2019 using advertising materials that contained multiple false and misleading statements about their purported safety and effectiveness.

As part of the plea agreement, Kosolcharoen admitted that to mislead FDA about Liveyon’s activities, he directed Liveyon’s purchase orders to falsely state that the stem cell products were being sold “for research purposes only.” In 2018, FDA and the Centers for Disease Control and Prevention (CDC) received reports of patients in multiple states requiring hospitalization for bacterial infections after receiving Liveyon products. Kosolcharoen admitted that he and others fraudulently induced customers into purchasing stem cell-derived Liveyon products by, among other things, misleading the public about the cause and severity of adverse events suffered by Liveyon patients, and falsely reporting and concealing material facts regarding the outcome of an FDA inspection of Genetech. According to FDA records, that inspection documented evidence of significant deviations from good manufacturing and tissue practices.

“Unapproved stem cell treatments not only endanger public health but also exploit the hopes of patients who seek relief from the most serious of diseases,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The Department of Justice is committed to safeguarding the public from these schemes and will vigorously pursue legal action to hold accountable those who unlawfully market and sell these unproven therapies.”

FDA statement: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-inv…


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