Conclusion: A Review of FDA’s Approach to Medical Product Shortages
Medical product shortages are harmful to nearly all parties involved. This shared experience can help motivate stakeholders to collaborate in developing approaches that might serve to prevent, ameliorate, and resolve this significant public health problem.
However, the problem of medical product shortages is complex and stems from economic, legal, regulatory, policy, and clinical decisions that are deeply interconnected. Many parties along the entire supply chain, including essential raw ingredient suppliers, API manufacturers, final drug product manufacturers, wholesalers, GPOs, clinicians, and ultimately, patients, are affected. While FDA has taken on the task of working with manufacturers to help prevent and mitigate these shortages, preventing 38 drug shortages in 2010 and 99 to date in 2011, many of the root causes and potential solutions lie beyond its purview. The Agency is also limited in its authorities as it formulates a response to the problem. Nonetheless, this report has identified a number of respects in which FDA’s internal processes might be improved, so that FDA is maximizing its contribution to the prevention and mitigation of shortages.
There is no single or simple solution that can resolve the medical product shortage problem. Efforts to address the problem will need to be multifaceted, sustained over the long-term, and will require the engagement of all parties involved in the manufacture and distribution of medical products.