Cracking Down on Counterfeiting

Aug 02, 2006



In the fight against counterfeit drugs in the United States, there's good news and bad news. The good news is that the US drug supply remains the safest in the world and we have the technology to keep it that way. The bad news is that counterfeiters are more sophisticated than ever, and the pharmaceutical industry has been slow to take protective measures.

FDA raises the bar on regulations

On June 8, 2006, the US Food and Drug Administration endorsed the recommendations of its Counterfeit Drug Task Force as outlined in the Counterfeit Drug Task Force Report: 2006 Update (1).


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The 2006 document builds on the Task Force's 2004 and 2005 reports and reflects input from public comments and a February 2006 workshop. Among its major recommendations, the Task Force advised the agency not to extend the stay of the pedigree requirement of the 1992 Prescription Drug Amendments of the Prescription Drug Marketing Act of 1987 (PDMA).

As a result, drug distributors will be required to provide pedigree, or chain-of-custody, documentation about products that pass through their hands after Dec. 1, 2006 when the stay expires. FDA defines a drug pedigree as "a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them. Under the pedigree requirement, each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug" (2).

Because members of the pharmaceutical supply chain have known since the passage of the PDMA that pedigree documentation would be required at some point and several states have passed pedigree laws, the Task Force believes "FDA can no longer justify delaying implementation of these regulations" (1). It also thinks that "continuing the stay would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices to flourish" (1).

The Task Force also feels meeting federal pedigree requirements should be less of a burden now because members of the pharmaceutical supply chain are already working to comply with a growing number of state pedigree requirements.

Once the stay expires, the Task Force recommends the agency take a risk-based approach to enforcement and focus initially on the drug products that are most vulnerable to counterfeiting and diversion, thus allowing the industry to adopt a phased pedigree implementation. The agency has issued draft Compliance Policy Guide (CPG) 160.900 that describes four factors for field personnel to consider when enforcing pedigree requirements.

According to the draft CPG, pedigree requirements will be enforced initially for products that meet one or more of the following criteria:

  • high value in the US market because of high volume, price, or demand, with special attention to drugs for serious or life-threatening conditions and products in short supply;
  • prior history of counterfeiting or diversion of the drug itself or others in its class;
  • reasonable probability that a newly approved drug will be counterfeited or diverted;
  • entities that are violating the PDMA or other laws.

Guidance documents do not contain legally enforceable requirements, but rather describe the agency's current thinking and should be viewed as recommendations unless specific regulations or statutes are cited. Comments on the draft CPG were due July 14, 2006. A final document is expected to be published before the stay expires on Dec. 1, 2006.