ALEXANDRIA, Va. – Two sales representatives for Gallant Pharma International, Inc., pleaded guilty Thursday to selling misbranded Botox and other drugs, following a joint investigation by U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) Washington; Food and Drug Administration’s Office of Criminal Investigations; Washington Division of the U.S. Postal Inspection Service; and the Arlington Police Department.
Patricia Durr, 49, of Hopkinton, Ma., and Lisa Coroniti, 46, of Philadelphia, are the sixth and seventh members of Gallant Pharma, respectively, to enter guilty pleas:
- On Oct. 3, sales representative Harvey Whitehead, 68, of Troy, Mich. pleaded guilty to selling misbranded chemotherapy drugs and to engaging in unlicensed wholesale prescription drug distribution;
- On Oct. 3, former sales representative Michael Merriam, 32, of Toronto pleaded guilty to selling misbranded Botox;
- On Oct. 8, Gallant Pharma office manager Robert Sparks, 30, of Springfield, Va., pleaded guilty to introducing misbranded drugs into interstate commerce;
- On Oct. 15, Gallant Pharma co-founder and co-owner Talib Khan, 42, of Montreal and Barbados, pleaded guilty to selling misbranded chemotherapy and cosmetic drugs, and conspiracy to commit importation fraud, sell misbranded drugs, distribute prescription drugs without a license, and defraud the FDA; and
- On Nov. 4, former Gallant Pharma office manager Tanya Smith, 40, of Springfield and Manassas, Va., pleaded guilty to introducing misbranded drugs into interstate commerce.
Between October 2010 and August, Durr sold more than $2.6 million in misbranded and non-FDA-approved intravenous chemotherapy drugs and injectable cosmetic drugs and devices (including tampered vials of Botox) to 33 doctors and medical practices in Massachusetts and Connecticut. Coroniti likewise admitted that, between June 2011 and August, she sold more than $1.1 million in misbranded and non-FDA-approved intravenous chemotherapy drugs and injectable cosmetic drugs and devices to 15 doctors and medical practices in the greater Philadelphia area.
Many of the drugs sold by Durr and Coroniti were required to contain a "black box" warning, the strongest warning issued by the FDA, which indicates that a drug has a significant risk of serious or life-threatening adverse effects. The versions sold by Gallant Pharma did not meet this or other FDA labeling requirements. Many of the drugs sold by Gallant Pharma were also subject to strict temperature controls and were required to be shipped in dry ice to protect the drug efficacy, which Gallant Pharma could not do.
Durr and Coroniti each face a maximum penalty of three years’ imprisonment when they are sentenced. Durr will be sentenced on Feb. 28 and Coroniti March 21.