Drug Executive Admits Making False Statements to FDA Over Weight Loss Drug

Pharmaceutical company executive Alain Bouaziz, a French citizen and resident of the United Arab Emirates, pleaded guilty before a U.S. district judge in a Newark, N.J. federal court to making false statements to the FDA.

Bouaziz had presented himself as CEO of Hexim Pharmaceuticals, previously known as Alkopharma USA. Beginning in February 2018, Bouaziz submitted forged documents and made false statements to the FDA to try to fraudulently gain control of Sanorex (mazindol), a weight-loss pharmaceutical drug owned by Novartis in the U.S., but licensed to NLS Pharmaceuticals in many countries in 2021.

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 U.S.

“These representations were false because neither Hexim nor Alkopharma owned the rights to distribute Sanorex,” the DOJ said.

Bouaziz is scheduled for sentencing on Dec. 14. He could face a five-year prison sentence and a fine of up to $250,000.