At Senate HELP Committee Hearing, FDA Official Says Bennet’s Proposed Universal Pedigree System Would Help Avoid Drug Shortages, Improve Drug Safety
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A Food and Drug Administration (FDA) official today expressed support for Colorado U.S. Senator Michael Bennet’s call for a universal system to monitor pharmaceutical drugs through the supply and distribution chains to help avoid critical drug shortages and increase prescription drug safety.
At the Senate Health, Education, Labor and Pensions Committee hearing today Bennet asked Dr. Sandra Kweder, deputy director of FDA’s Office of New Drugs, “Even in this time of fiscal constraint, I am supportive of a drug distribution system. While it doesn’t create undue burdensome cost for any part of the supply chain, it would provide us knowledge about where drugs are in the system. And I wonder whether you think it would be helpful for FDA and other supply chain stakeholders to have information on the legitimacy and pedigree of a drug, particularly when a drug is in shortage?”
In response, Kweder said, “Yes. I think that it won’t solve a drug shortage problem, but it would allow hospitals, pharmacies and the agency to have a better idea of whether a product is a legitimate product. I already mentioned that one of the concerns that we have about the gray market is whether some of these are actual signals of counterfeit, and that would make assess that very much more straight forward.”
The FDA also recently responded to Bennet’s letter pushing for the FDA to consider a uniform pedigree standard as a component of a comprehensive solution to drug safety and drug shortage problems.
“We agree that implementation of a uniform pedigree or track-and-trace system may help further secure the integrity of the drug supply chain by providing transparent and accurate information on the origin, source, and handling of a drug throughout the supply chain,” Jeanne Ireland, assistant commissioner for legislation, wrote in the letter. “…A robust track-and-trace system may help protect consumers from threats posed by illegal or substandard products, which may result from a drug shortage situation, in addition to providing accountability and transparency of the supply chain.”
A uniform pedigree standard would allow the FDA to efficiently monitor individual drugs as they move through the supply and distribution chain, thereby ensuring that all drugs are manufactured, stored and distributed safely, and that they enter distribution channels legally.
Potential drug shortages would be easier to identify and avoid with a uniform pedigree standard because the FDA would be able to verify the amount of each drug currently available or in the manufacturing process. And providers purchasing products in short supply would be in a much better position to verify the safety and authenticity of a product.
In Colorado Springs, drug shortages have forced doctors at Penrose-St. Francis Hospital to delay therapy for some leukemia patients, and to substitute less effective antibiotic medications for those that are in short supply. Drug shortages can also lead to price gouging and prescription drug offers from the “gray market,” where doctors and hospitals cannot be sure of the safety, origin and handling of drugs through the supply chain.