A Georgia physician has pleaded guilty to the introduction into interstate commerce of a misbranded drug product, a supposed weight loss medicine marketed as “Releana.”
Audrey Arona, 64, of Gainesville, Georgia, pleaded guilty Monday. Arona was ordered to pay $65,000 as part of a plea agreement. She admitted to selling Releana nationwide and to saying that the drug was federally approved even though it was not.
Arona is also listed by the Georgia Department of Public Health as a director for health district 3-4, which covers the state’s Gwinnett, Rockdale, and Newton counties. The Justice Department did not specify whether or not her guilty plea affects her employment with GDPH.
Releana contains human chorionic gonadotropin, a hormone produced by the placenta. While the Food and Drug Administration has approved the hormone’s use for infertility treatment in women and hormone treatment in men, HCG has not been approved for weight loss.
In fact, the FDA warns consumers against HCG weight loss products. Diets that feature it, the FDA says, get their efficacy from the severe restriction of caloric intake, as opposed to any effects HCG may have.
The label of approved HCG-containing drugs even state that there “is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets,” the FDA notes.
Doctors are not allowed to distribute misbranded, non-approved medicines.
Arona was the third defendant to plead guilty in relation to the distribution of Releana, according to the Justice Department.
In September 2022, Georgia resident Maurice Bailey pleaded guilty to introducing a misbranded drug containing HCG into interstate commerce, which involved preparing the Releana in an unregistered facility before it was then sold by Arona.
In August 2021, a Colorado resident and fellow Releana distributor, Sarah Alberg, pleaded guilty to introducing the misbranded drug product containing HCG with the intent to mislead or defraud. Alberg smuggled HCG into the U.S. from India, and distributed Releana using bottles and supplies exposed to rodent droppings.
“Doctors who distribute drugs must comply with federal law designed to ensure these products are safe and effective,” Principal Deputy Assistant Attorney General Brian Boynton said.
Source : https://www.washingtontimes.com/news/2023/apr/25/georgia-doctor-audrey-arona-pleads-guilty-distribu/?utm_source=RSS_Feed&utm_medium=RSS&rand=1247