House lawmakers pressed a Food and Drug Administration official on the need for a federal “track-and-trace” system that would boost the security of the pharmaceutical supply chain in the U.S. at a time when counterfeit or substandard drugs are increasingly of concern.
States, for the most part, regulate the drug supply chains in their regions, with some requiring paper or electronic transaction histories of drugs, which are called pedigrees.
Not all states require pedigrees, though—an issue that has prompted questions about the safety of the supply chain. Other states, such as California and Florida, are known for the more rigorous track-and-track policies that they are putting into place.
Earlier this week, Reps. Bob Latta (R-Ohio) and Rep. Jim Matheson (D-Utah) released draft legislation that would create a national standard for tracking drugs as they pass through a pharmaceutical supply chain that includes manufacturers, wholesale distributors, pharmacies and repackagers.
During a House subcommittee's hearing Thursday on the draft legislation, Rep. Fred Upton (R-Mich.) said he expects a bill to go to President Barack Obama before the August recess. The Healthcare Distribution Management Association said in a statement that it supports the draft bill.
“A comprehensive, practical approach would result in increased safety, continued efficiencies and minimal inconsistencies among competing state requirements—all of which will enable HDMA distributors and our supply chain partners to continue to deliver prescription drugs safely and efficiently every day,” Elizabeth Gallenagh, HDMA's vice president of government affairs and general counsel, said in the statement.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, testified during the hearing that the ultimate goal for the agency would be to have a system that tracks products down to the unit level. However, Woodcock expressed concern that any efforts to develop a national standard should not have a negative impact on the rules currently in place.
“The paper pedigree is a mainstay right now,” she said during the hearing. “We mustn't weaken that.”
A number of recent lapses in the drug supply chain have led to increased support for a national drug track-and-trace system.
As drug shortages have worsened, more hospitals have sought out alternative sources to purchase drugs in short supply. Some providers have said they had to forgo those purchases over safety and quality concerns of buying from pharmacies and distributors that operate in states that do not require a pedigree.
Other cases of substandard drugs in the supply chain include the tainted steroid injections that led to the deaths of 53 people. The contaminated drugs, which were manufactured by the New England Compounding Center, a now-closed compounding pharmacy that had distributed the products to healthcare facilities in 23 states, eventually prompted a broad investigation into how compounders operate in the U.S.
And, also last year, the FDA reported that counterfeit versions of Adderall and Vicodin ES were being sold online. The agency also had notify up to 500 medical practices in the U.S. that they may have purchased counterfeit versions of a cancer drug.
“Counterfeit drugs are not the only problem; stolen or diverted products also pose a threat to patients,” Woodcock said in her prepared remarks. “Once products leave the legitimate supply chain, we have no idea how they are being stored or handled—or even if they have expired.”
The Institute of Medicine released a report (PDF) in February that said poor-quality drugs can lead to treatment failure as well as increase costs to both patients and the health system. Among the IOM's recommendations was one suggesting governments should either establish or strengthen systems that detect illegitimate drugs, including that the U.S. develop a mandatory drug tracking system.
“The problem is getting worse,” Woodcock said.
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