May 23, 2013
How Safe is Your Medicine?
Yesterday, after several years of collaboration in the Senate with industry and consumer advocates, the Senate HELP Committee approved a bipartisan bill to strengthen and improve our nation’s drug distribution supply chain. It marks the first comprehensive effort in 25 years to establish safeguards for the drug distribution supply chain and follows several cases of counterfeit drugs like the Avastin cancer drug scare last year.
The Drug Supply Chain Security Act, which we introduced last week with Senator Richard Burr, HELP Committee Chairman Tom Harkin, and Ranking Member Lamar Alexander, will improve patient safety. It replaces today’s patchwork of state product tracing laws to track pharmaceutical drugs with a strong, uniform standard. It will ultimately result in electronic, interoperable unit-level product tracing for the entire country.
Currently, you can get more data from a barcode on a gallon of milk than you can from a bottle of aspirin two aisles over. Our bill will change that by establishing a track-and-trace system that will help us identify counterfeit drugs or detect stolen or recalled products. It is a comprehensive and practical approach that will increase safety and minimize inconsistencies among the current patchwork of state requirements.
The bill would establish a workable pathway to a unit-level tracing system over the course of a decade. It requires each participant in the drug supply chain to maintain detailed records about each transaction as pharmaceutical drugs change hands. No one in the supply chain would be allowed to accept products if information pertaining to transaction history is not provided as part of the change of ownership.
Over the course of seven years, the major participants in the pharmaceutical supply chain, such as manufacturers, re-packagers, wholesale distributors, and dispensers will all be passing along and holding onto transaction information and history, as applicable, for each drug product. Within that time, the Food and Drug Administration (FDA) will work to establish the details for the drug supply chain on uniform standards to make an interoperable, electronic drug tracing system.
The bill also strengthens licensing requirements for wholesale distributors and requires FDA to keep a database of wholesalers that will be available to the public through the FDA’s website. This empowers both consumers and members of the pharmaceutical distribution supply chain to identify appropriately licensed wholesalers.
Families in Colorado and all across the country deserve the peace of mind to know that the medicines they take are safe and effective. This bill will help restore confidence in our drug supply and distribution chain.