Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
November 6, 2013
United States Attorney
Eastern District of Virginia
Contact: Press Officer
ALEXANDRIA, Va. - Patricia Durr, 49, of Hopkinton, Massachusetts, and Lisa Coroniti, 46, of Philadelphia, Pennsylvania, both sales representatives for Gallant Pharma International Inc., headquartered in Arlington, Virginia, pleaded guilty today to selling misbranded Botox and other drugs.
Dana J. Boente, Acting United States Attorney for the Eastern District of Virginia; Antoinette V. Henry, Special Agent in Charge of the Food and Drug Administration's (FDA) Office of Criminal Investigations; Gary Barksdale, Inspector in Charge of the Washington Division of the U.S. Postal Inspection Service; Acting Special Agent in Charge Scot R. Rittenberg for U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI) in Washington, D.C.; and M. Douglas Scott, Arlington Chief of Police, made the announcement after the pleas were accepted by United States District Judge Hilton.
Durr and Coroniti are the sixth and seventh members of Gallant Pharma, respectively, to enter guilty pleas:
- On October 3, 2013, sales representative Harvey Whitehead, 68, of Troy, Michigan, pleaded guilty to selling misbranded chemotherapy drugs and to engaging in unlicensed wholesale prescription drug distribution;
- On October 3, 2013, former sales representative Michael Merriam, 32, of Toronto, Canada, pleaded guilty to selling misbranded Botox;
- On October 8, 2013, Gallant Pharma office manager Robert Sparks, 30, of Springfield, Virginia, pleaded guilty to introducing misbranded drugs into interstate commerce;
- On October 15, 2013, Gallant Pharma co-founder and co-owner Talib Khan, 42, of Montreal, Canada 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 November 4, 2013, former Gallant Pharma office manager Tanya Smith, 40, of Springfield, Virginia, and Manassas, Virginia, pleaded guilty to introducing misbranded drugs into interstate commerce.
According to court documents, between October 2010 and August 2013, 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 2013, 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, Pennsylvania, 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 February 28, 2014 and Coroniti on March 21, 2014. A jury trial is scheduled for January 6, 2014, for alleged Gallant Pharma co-founder and co-owner Syed "Farhan" Huda, 38, of Arlington, Virginia; his wife and alleged Gallant Pharma administrator Deeba Mallick, 36, of Arlington, Virginia; alleged supplier Mirwaiss Aminzada, 44, of Dubai, United Arab Emirates, and Montreal, Canada; and alleged drop-shipper and customer Anoushirvan Sarraf, 47, of Rockville, Maryland.
This case was investigated by FDA's Office of Criminal Investigations, the Drug Enforcement Agency's Group 33 Diversion Task Force, ICE, and the U.S. Postal Inspection Service, with assistance from the Arlington County Police Department. Assistant United States Attorneys Lindsay Kelly, Ryan Dickey, Jay Prabhu, and Maya Song are prosecuting the case on behalf of the United States.
A copy of this press release may be found on the website of the United States Attorney's Office for the Eastern District of Virginia at http://www.justice.gov/usao/vae. Related court documents and information may be found on the website of the District Court for the Eastern District of Virginia at http://www.vaed.uscourts.gov or on https://pcl.uscourts.gov.