White Paper on Preventing Drug Shortages
A new white paper by the Duke Margolis Center for Health Policy recommends that the federal government and Congress “take urgent action to establish a new coordinating effort, the Prevent Drug Shortages Initiative, with requisite authorities and funding to lead a cross-cutting effort to improve drug supply chain reliability, including producing measurable reductions in the frequency and severity of shortages of critical drugs.”
The paper’s top recommendation calls on the government and private sector to collaborate on developing and implementing tools that measure supply chain reliability, including FDA’s proposed Quality Management Maturity program (see earlier story), for drugs at high risk of shortages. “A system-wide lack of supply chain reliability insights makes it difficult to assess supply chain vulnerabilities and leaves purchasers to choose suppliers primarily based on price, not reliability of supply chains,” it says. The PDS Initiative should lead to a robust toolkit of actionable supply chain reliability measures that are readily available to purchasers, manufacturers, and other stakeholders, it adds.
The paper notes that QMM is the “state attained by having consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.” It says QMM supports sustained compliance and reliable production of quality drugs over time, and it is “one of the most important elements of supply chain reliability.”
It recommends adjustments to the QMM program based on learnings from the recently completed pilot program and other stakeholder feedback. “For example,” it says, “QMM should be carefully targeted towards essential generic medicines at risk of shortage and mechanisms to share useful information on supply reliability with the correct supply chain stakeholders, while appropriately protecting proprietary information…”
Additionally, the paper calls for the federal government to “pursue a proactive, coordinated focus on preventing the most impactful drug shortages, regardless of the cause… The PDS Initiative would ensure adequate, proactive focus on addressing economic and other issues to prevent supply-driven, chronic drug shortages.”
It says Congress should authorize and provide funding to staff and implement the PDS initiative with an initial focus on reducing chronic drug shortages. It also calls for Congress to provide additional funding to develop and implement FDA’s Quality Management Maturity (QMM) program or a similar program, either managed by FDA or through an independent third party with significant agency oversight.