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Balderson, Kuster Warn FDA of Looming Drug Supply Chain Disruptions

WASHINGTON D.C. – U.S. Representatives Troy Balderson (R-OH) and Ann Kuster (D-NH) led a bipartisan letter to the Food and Drug Administration (FDA) warning of possible drug shortages and supply chain disruptions if the FDA fails to act ahead of the enforcement deadline of the Drug Supply Chain Security Act (DSCSA).

The letter outlines issues facing pharmaceutical manufacturers, distributors, and dispensers as they work to bring the drug supply chain into compliance with DSCSA requirements. Beginning November 27, 2023, all drugs must be able to be tracked electronically on the unit level. Any drugs that do not comply with the new requirements cannot be distributed or dispensed to patients. While well intentioned, it is critical the FDA ensures that DSCSA requirements do not lead to shortages of life-saving drugs for Americans. 

“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.”

“However, it is our understanding that some supply chain participants are facing difficulties meeting DSCSA’s full implementation requirements. Based on what we are hearing from healthcare supply chain stakeholders about readiness for the November 27th deadline, absent government intervention, there will likely be disruptions that could lead to patient access problems and further drug shortages.”

The letter is supported by the Healthcare Distribution Alliance (HDA), American Pharmacists Association (APhA), National Association of Boards of Pharmacy (NABP), National Community Pharmacists Association (NCPA), and National Association of Chain Drug Stores (NACDS).

“HDA applauds the bipartisan efforts of Reps. Balderson and Kuster to engage with the FDA to ensure that the final implementation of DSCSA is done efficiently and effectively to minimize the very real, yet avoidable, risk to patient care if the supply chain is disrupted,” said Kristen Freitas, SVP of Federal Government Affairs and Alliance Development at HDA.

Balderson and Kuster are joined by Representatives Mariannette Miller-Meeks (R-IA), Buddy Carter (R-GA), Angie Craig (D-MN), Dan Crenshaw (R-TX), Don Davis (D-NC), Lori Trahan (D-MA), Brian Fitzpatrick (R-PA), Carol Miller (R-WV), Mike Carey (R-OH), Larry Bucshon (R-IN), Doug Lamborn (R-CO), Pat Ryan (D-NY), Bill Johnson (R-OH), Kim Schrier (D-WA), Bradley Schneider (D-IL), Michael Burgess (R-TX), Gus Bilirakis (R-FL), Claudia Tenney (R-NY), David Kustoff (R-TN), Diana Harshbarger (R-TN), Debbie Dingell (D-MI), John Joyce (R-PA), Bob Latta (R-OH), Susan Wild (D-PA), Marc Veasey (D-TX), and Greg Landsman (D-OH).

A copy of the full letter to the FDA can be found HERE.

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