French National Charged with Making False Statements to FDA to Fraudulently Obtain Control of Pharmaceutical Product | USAO-NJ

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NEWARK, N.J. – A French national will make his initial appearance today for his role in an attempt to fraudulently gain control of the rights to sell a weight-loss drug in the United States, Acting U.S. Attorney Rachael A. Honig announced.

Alain Bouaziz, 68, a French citizen and resident of the United Arab Emirates, was arrested at Newark Liberty Airport while attempting to depart the United States. Bouaziz is charged by complaint with making false statements to the U.S. Food and Drug Administration (FDA). He is scheduled to appear today by videoconference before U.S. Magistrate Judge Cathy L. Waldor.

According to documents filed in this case and statements made in court:

Bouaziz is a French citizen and resident of the United Arab Emirates who represented himself to be the chief operating officer of Hexim Pharmaceuticals (Hexim), a company headquartered in Secaucus, New Jersey. Hexim was known as Alkopharma USA Inc. until its name was changed in June 2013.

Beginning in February 2018, Bouaziz submitted forged documents and made false statements to the FDA to fraudulently gain control of Sanorex, a weight-loss pharmaceutical owned by a major international pharmaceutical company (Pharmaceutical Company-1). Bouaziz sent letters and documents by email and in hard copy to the FDA falsely stating that Hexim had purchased the New Drug Application for Sanorex and requesting a meeting about marketing Sanorex in the United States. Bouaziz knew these representations were false because Hexim had not purchased the rights to Sanorex from Pharmaceutical Company-1. The documents that Bouaziz submitted to the FDA contained multiple forgeries and false statements, including one example where an earlier agreement between Alkopharma and Pharmaceutical Company-1 had been altered to purport to show a sale of Sanorex to Hexim.

The false statements charge carries a maximum term of five years in prison and a fine of up to $250,000 or twice the gross gain or loss caused by the offense, whichever is greatest.

Acting U.S. Attorney Honig credited special agents of the Food and Drug Administration, Office of Criminal Investigation, under the direction of Special Agent in Charge Jeffrey Ebersole, with the investigation leading to the charges.

The government is represented by Assistant U.S. Attorney Hayden M. Brockett of the Health Care Fraud Unit in Newark.

The charge and allegations contained in the complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.



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