A draft policy from the FDA’s counterfeit drug task force, concerns drugs marketed in the United States that do not have required FDA approval and emphasizes the regulatory actions and the use of new technologies for safeguarding the integrity of the U.S. drug supply.

Dr. Andrew C. von Eschenbach, the FDA’s Acting Commissioner say vigilance is needed to protect Americans from “an increasingly sophisticated criminal element engaging in a dangerous type of commerce”.

The FDA says in future it will fully implement regulations in regard to the marketing of prescription drugs which will entail drug distributors providing documentation of the ‘pedigree’ of drugs.

Early in 2004, the FDA granted the industry extra time to adopt electronic track and trace technology for following drugs through the supply chain.

Such technology was expected to be in widespread use by 2007, but it now appears that these expectations will not be met.

The FDA says the concerns raised in the past regarding the impact on small wholesalers do not now exist and allowing the hold to expire in December will provide clarity and clear the confusion in the drug supply chain regarding who is and is not required to pass a pedigree.

The FDA says the enforcement of the pedigree regulations will focus on products most susceptible to counterfeiting and diversion.

The draft compliance policy will provide guidance on the types of drugs that are currently of greatest concern to FDA and give wholesale distributors a better idea on how to comply with the regulations of the prescription drugs they distribute.

The FDA may also initiate regulatory action, including criminal prosecution, for pedigree violations that do not meet the factors listed in the guidance.

The Task Force’s report includes some advice on key issues which must be resolved regarding the electronic tagging of drugs including unique identifiers or serial numbers which are accepted as a nationwide universal drug pedigree with uniform information and the protection of consumer privacy to prevent unauthorized disclosure of information.

The report is the third in a series of documents exploring the means of ensuring the safety of the U.S. drug supply.

All Task Force Reports are posted on FDA’s Web at www.fda.gov/counterfeit.