U.S. Rep. Troy Balderson (R-OH) helped lead a bipartisan contingent of 27 of his colleagues in warning the Food and Drug Administration (FDA) that it should prepare to take action to minimize the potential for disruptions to supply and patient care as the FDA approaches the final implementation of the Drug Supply Chain Security Act (DSCSA).
Congress in 2013 mandated that all U.S. manufacturers, distributors, and dispensers meet the DSCSA’s final requirements no later than Nov. 27, 2023, at which time manufacturers, distributors, and dispensers must begin electronically capturing and sharing interoperable data at the individual package level, according to an Aug. 1 letter Rep. Balderson and his colleagues sent to FDA Commissioner Dr. Robert Califf.
Currently, prescription drugs can only be traced at the lot level. The DSCSA has been phased in over the course of the last 10 years and ultimately will allow tracking of a product’s chain of ownership at the unit level from the manufacturer to the pharmacy, the lawmakers wrote.
“The FDA’s efforts to protect patients have been enhanced by the systems and processes implemented across the supply chain over the past decade,” the representatives wrote. “Further efforts required by the DSCSA will ultimately improve the ability to trace pharmaceutical products and remove potentially dangerous products from the pharmaceutical supply chain.”
Rep. Balderson was joined in signing the letter by U.S. Reps. Buddy Carter (R-GA), Brian Fitzpatrick (R-PA), Carol Miller (R-WV), Larry Bucshon (R-IN), Bill Johnson (R-OH), Michael Burgess (R-TX), John Joyce (R-PA), Bob Latta (R-OH), and Ann Kuster (D-NH).
In their letter, the members pointed out that some supply chain participants are facing difficulties meeting DSCSA’s full implementation requirements by the Nov. 27 deadline, and absent government intervention, they noted that there will likely be disruptions that could lead to patient access problems and further drug shortages.
“As you are aware, Congress is examining the issue of drug shortages and we are concerned about how these interruptions will affect our constituents, many of whom are already experiencing the consequences of various drug shortages,” the lawmakers wrote. “It is likely that FDA will need to take action to help avert significant disruptions in patient care and access to medications.”
To help the FDA ensure that the lack of readiness by some in the supply chain, as well as failures in data exchange, do not pose serious risks to patients, the members asked Califf to answer several questions by Sept. 15 to inform them about the steps the FDA is taking to address the issue of potential disruptions to patients as a result of DSCSA noncompliance.
The letter is supported by the Healthcare Distribution Alliance, the American Pharmacists Association, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, and the National Association of Chain Drug Stores.