Electronic pedigree gains momentum in Congress

Congressman Steve Buyer (R, Ind.) and Jim Matheson (D, Utah) have introduced the Safeguarding America's Pharmaceuticals Act, which would mandate national e-pedigree standards. The measure is expected to be folded into a larger bill that will likely be introduced this summer by Rep. John Dingell (D, Mich.), chairman of the House Energy and Commerce Committee.

Rep. Buyer became interested in preventing counterfeit drugs from entering the U.S. drug supply after visiting U.S. mail facilities that process and ship incoming products from other countries.

"The FDA is confident that the United States and its closed drug supply is safe and we continue to work with manufacturers, wholesalers, and retailers to ensure this," said FDA spokesperson Christopher Kelly.

Currently, the FDA screens about 1% of the estimated 30,000 products that are processed each day through these facilities. The agency has found that more than 80% of products are counterfeit, adulterated, or misbranded during routine searches at the country's 12 international mail facilities.

National standard

If enacted, the Act would establish rigorous new pedigree requirements that would apply uniformly across all 50 states. States would continue their important role in licensing and enforcement. The bill would require e-pedigrees on all prescription medicines sold in the United States. Longer term, the legislation will require manufacturers, distributors, and pharmacies to put in place systems and technologies that will electronically track and trace individual prescription medicines.

A healthcare legislative aide from Rep. Buyer's office said that the measure is a technology-neutral bill "because we want to make sure the system can quickly react to new technologies because counterfeiters will always be one step ahead of us."

The Generic Pharmaceutical Association (GPhA) agrees with a technology-neutral approach. "A system with multiple technologies would create great confusion within the supply chain," said GPhA President and CEO Kathleen Jaeger. "Most of all, it would harm patients who will be left waiting for their medicines. Due to their low costs, generics are not really targets of counterfeiters. To keep costs affordable, we must work together to create a system that does not lead to less competition, delayed access, and higher costs for consumers."