The Department of Justice recently announced that an Athens, Texas woman has been sentenced to more than one year in prison for her role in the smuggling of imitation, unapproved, and misbranded prescription drugs from China.
The middle-aged defendant pleaded guilty in April 2015 to one count of conspiracy to smuggle the drugs into the United States. She was sentenced to 15 months in prison, followed by two years of supervised release. Two co-defendants, also of Athens, were each sentenced to 15 months in prison in October 2015.
“Consumers of prescription drugs need to know that what they are buying is legitimate, safe, and approved,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “This illegal operation introduced more than 100,000 bogus pills into the stream of commerce, potentially posing a huge public health and safety risk. Consumers should know that the drugs they are buying are exactly what they appear to be, and not false versions of name-brand products that could ultimately do them more harm than good.”
In 2009, the defendants smuggled at least 43 known shipments, totaling approximately 106,000 pills, from China to Texas. The shipments contained unapproved, bogus versions of several FDA-approved drugs that, because of the health and safety risks associated with their use, require valid prescriptions to dispense. The prescription drugs seized included: Xanax; Valium; sibutramine; Cialis; Viagra; and Stilnox, marketed in the United States as Ambien. None of the pills that were seized and tested were legitimate. Some were sub-potent, but most contained entirely different active ingredients from their legitimate, approved versions. The defendants attempted to hide their smuggling by using shipping labels that concealed the contents of their shipments and customs documents falsely describing the contents as “gifts” or “toys.” They used multiple addresses in an effort to reduce the likelihood of seizures by U.S. Customs and Border Protection authorities.
“This office remains committed to stemming the increasing flood of illegitimate prescription drugs that come into East Texas,” said U.S. Attorney John M. Bales for the Eastern District of Texas. “This case puts the very real, inherent dangers of counterfeit prescription drugs on full display. These pills looked almost exactly like their legitimate counterparts, but lacked any of the safety or efficacy of the legitimate versions.”
“FDA’s laws are in place to ensure that consumers have access to safe and effective prescription drugs,” said Director George M. Karavetsos of the FDA’s Office of Criminal Investigations. “Those who evade those laws risk harming the public’s health. We will continue to work with our law enforcement partners to keep the U.S. marketplace free of illegitimate medical products.”
See the DOJ Announcement
See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See the Medical Law Perspectives February 16, 2015, Blog: Pharmacy Owes Duty to Patient Not to Fill Excessive Prescriptions for Opioids
See the Medical Law Perspectives October 8, 2014, Blog: Opioid Pain Pill Abusers Switch to Heroin; Heroin Overdose Deaths Double