Combating Counterfeit Drugs May 2005 Update - Conclusion
Significant progress has been made towards implementing the measures outlined in FDA's Combating Counterfeit Drugs Report issued in February 2004. Although the use of electronic track and trace technology is still in the implementation stage, adoption and widespread use is closer to becoming a reality as stakeholders work diligently to find solutions to the challenges faced along the way. The use of authentication technologies is gaining acceptance as manufacturers realize that steps should be taken to protect their products from sophisticated counterfeiters. States are starting to adopt stricter laws and harsher penalties to ensure that only legitimate wholesalers do business in their state and they are taking measures to do their part in protecting supply chain integrity. Trading partners in the drug supply chain are also taking steps to ensure secure business practices are adopted and utilized as drug products are bought and sold. Educational efforts have been undertaken to help health professionals and consumers develop a greater awareness and knowledge about counterfeit drugs and how to minimize the risks of exposure. In addition, efforts are underway to tackle counterfeit drugs on a global level.
Despite the progress made, there remains a viable and concrete threat of counterfeit drugs entering the U.S. drug distribution system. We must all continue to work together to expeditiously pursue the measures outlined in the Report to further protect the safety and security of the U.S. drug supply.
APPENDIX: Significant Counterfeit Cases Closed in the Past Year
Below are a number of significant counterfeit drug cases that were closed in the past year:
During the first quarter of 2005, three men pled guilty to federal criminal charges in a multi-million dollar Lipitor smuggling and counterfeiting conspiracy. The pleas are a result of an ongoing OCI investigation involving the manufacturing, smuggling, and interstate distribution of counterfeit pharmaceuticals that was initiated by OCI in April 2003. To date, eight people have been indicted; four have pleaded guilty, and another was convicted by a trial jury.
In another counterfeit Lipitor case, an OCI undercover operation resulted in the arrest and conviction of a Belize citizen for violating Title 21, U.S.C. § 331 (a) – Introduction into Interstate Commerce of a Misbranded Drug. In September 2004 the defendant was sentenced to 10 months incarceration and 1 year probation.
Genapharm.com (Counterfeit Human Growth Hormone)
On March 9, 2004, an Austin, Texas man pled guilty to four counts of conspiracy to introduce misbranded and unapproved new drugs into interstate commerce, counterfeiting human growth hormone, and possessing controlled drugs with intent to distribute. Two other persons involved in these offenses were previously convicted and sentenced.
On June 23, 2004, an individual pled guilty to charges of conspiracy, trafficking in counterfeit goods, and a felony violation of the Federal Food, Drug and Cosmetic Act. In pleading guilty, the defendant admitted that he conspired with a manufacturer in Beijing to import thousands of counterfeit Viagra tablets into the United States, which he would then resell. The defendant was sentenced on March 25, 2005 to 18 months in prison, followed by 3 years probation and was fined $6000.
On June 16, 2004, an indictment was unsealed in San Diego that charged an individual with conspiring to unlawfully distribute human growth hormone and trafficking in counterfeit goods. According to the indictment, this individual obtained counterfeit Serostim and sold it to bodybuilders who did not possess lawful prescriptions for the drug. Another individual involved in this investigation pled guilty to similar charges on February 19, 2003. Serostim is a prescription drug containing the active ingredient "somatropin," a form of human growth hormone. Serostim is approved by the FDA for use in the U.S. to treat AIDS wasting disease.
Counterfeit Labeled Pharmaceuticals
An Alabama drug wholesaler was convicted for violating Title 21, U.S.C. § 331 (i) (3) – Selling and Holding for Sale a Counterfeit Drug. In October 2004 the company was sentenced to 5 years probation and fined $24,000.
In January 2005, a Southern California man pled guilty to importing counterfeit Viagra from China and manufacturing 700,000 counterfeit Viagra tablets at a lab in the U.S. An accomplice was convicted of similar charges in September 2004. The total value of the counterfeit Viagra in this case is more than $5.65 million.
World Express Rx
In January 2005, a San Diego man was sentenced to serve a 51-month prison term and forfeit substantial cash proceeds for his role in operating a large Internet pharmacy scheme. The drugs distributed included a variety of products counterfeited in Mexico, smuggled into the U.S. and sent throughout the country. Some of the ingredients for the drugs were shipped from India and China. In other instances, unapproved and counterfeit drugs made in India and Pakistan entered the U.S. via the Bahamas. At least 14 other individuals are also being prosecuted in California or Florida as part of this international conspiracy.