Regulatory Focus™ > News Articles > Two Receive Debarments for FDCA Violations

Two Receive Debarments for FDCA Violations

Posted 09 May 2012 | By Alexander Gaffney, RAC 

Two doctors are on the receiving end of debarment orders issued by the US Food and Drug Administration (FDA) after the agency found both to have injected patients with an unapproved and illegally obtained version of Botox (botulinum toxin) in violation of the Federal Food, Drug and Cosmetic Act (FDCA).

The two had separately obtained illicit versions of Botox-commonly used as a cosmetic agent to reduce wrinkles-from Toxin Research International, Inc (TRI).

The first, Daphne I. Panagotacos, a physician, was debarred by FDA after it determined Panagotacos had injected numerous patients, employees and even herself with a misbranded version of the botulinum virus obtained from TRI.

The agency initially said Panagotacos is barred from providing services to any company with an approved or pending drug product for five years, and upheld its decision after considering an appeal from Panagotacos.

FDA said it found her arguments to reconsider its action to be "unpersuasive," noting prior testimony contradicted several of her arguments against her debarment, and said Panagotacos' conduct "undermines the process for the regulation of drugs."

The agency also debarred Jerome Lentini, a medical doctor, for "misbranding a drug with an intent to defraud or mislead" after he, too, obtained supplies of the botulinum virus from TRI.

Despite knowing the supplies obtained from TRI were not approved, FDA said Lentini misrepresented the product he was using on patients as FDA-approved Botox.

"In fact, as defendant Lentini knew, he did not generally use BOTOX on patients but instead used another drug derived from botulinum toxin type A that had not been approved by FDA."

Lentini, appealed his initial debarment order, saying his original confession was obtained under "extreme duress." FDA brushed this argument aside, noting Lentini "specifically attested that he was voluntarily agreeing to plead guilty because he was guilty of the offense underlying his conviction," and had attested to being fully aware of the charges he was pleading to.

FDA also noted the FDCA "does not permit consideration of factors such as the circumstances of an individual's guilty plea," and upheld Lentini's lifetime debarment order.

Read more:

FDA - Daphne I. Panagotacos; Denial of Hearing; Final Debarment Order

FDA - Jerome Lentini; Denial of Hearing; Final Debarment Order


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