FDA Violations Lead To Disbarment

An attorney convicted on her plea of guilty to misprision of felony in Virginia federal district court has filed a motion for consent disbarment in Illinois

As part of that plea, Movant admitted that she  held various roles at Gallant including office manager, identifying prospective  customers for Gallant’s misbranded, non-FDA approved drugs, and arranging for  the importation and distribution of the drugs. Included as the imported drugs  were injectable chemotherapeutic agents, injectable cosmetic fillers, and  injectable agents used to treat side effects of chemotherapy, many of which were  subject to federally mandated strict temperature controls which were not  complied with by Gallant.

On May 16, 2014, the Honorable Claude M. Hilton  sentenced Respondent to nine months imprisonment in the Bureau of Prisons,  one-year of supervised release, and a fine of $75,000.

This press release from the United States Attorney for the Eastern District of Virginia summarizes the case

According to  information made public in court, between August 2009 and August 2013, Gallant  Pharma smuggled into the United States and sold more than $12.4 million in  non-FDA-approved chemotherapy drugs and injectable cosmetic drugs and devices,  generating profits of $3.4 million.  Many of these drugs were subject to  strict temperature controls to protect drug potency.  Gallant Pharma shipped  and received such drugs with ice packs, not dry ice as used by legitimate  distributors, and on at least one occasion, a shipment containing such drugs  took more than two weeks to arrive in Virginia from overseas during a July 2012  heat wave.  Many drugs sold by Gallant Pharma were also required to carry  a FDA “black box” warning, which indicates that a drug carries 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.

Law360 had this report on the criminal case against Gallant. (Mike Frisch)