Proposed Legislation to Help Fight Counterfeit Drugs

Democrats and Republicans might not agree on many issues, but the battle against counterfeit drugs has led to a bipartisan proposal that calls for a mandatory track and trace system.

Sponsored by Rep. Dan Burton (R-IN), the draft bill would require drug manufactures to use radio frequency identification (RFID) track-and-trace tagging technologies, tamper-indicating security measures, and blister security packaging when possible.

According to the bill, track-and trace technology could also be used to implement inventory control, verify shipment or receipt of prescription drugs, authenticate finished prescription drugs, and electronically authenticate the pedigree of prescription drugs.

In addition, the secretary of Health and Human Services would be required to publish a list of the 30 most frequently counterfeited prescription drugs in the United States within 180 days of the legislation's approval. The list would be named the National Specified List of Susceptible Prescription Drugs.

Drug products on that list would have to be made traceable no later than one year after the initial publication date or by Dec. 31, 2007, and the list would be revise every year until the end of 2009. The bill requires that all prescription drugs be have a supply-chain pedigree system by Dec. 31, 2010.

“This legislation is about safety and security,” Burton stated in a release. “We need to ensure the safety of the American consumer as well as ensure and verify the security of the prescription drug supply-chain in order to protect Americans from potentially harmful counterfeit drugs.”

The RFID Act has been referred to the Energy and Commerce Committee. The bill faces opposition from Rep. Steve Israel (D-NY) who feels that it relies too heavily on RFID, which has yet to receive industry-wide acceptance (see story in

PharmTech ePT

). Israel has proposed a separate legislation "Tim Fagan's Law" that gives the US Food and Drug Administration the authority to recall drugs; implement harsher penalties for criminals who pawn fake medicine off on innocent consumers, and requires paper pedigrees, according to release from Israel.