The Obama Administration issued an executive order to the FDA to combat continued drug shortages, the first to directly affect the FDA since 1985. The order is expected to have a significant positive impact on drug shortages per the order’s requirements that include: quickening the review process for applications to start or change production of drugs in shortage, widening the reporting of shortages, expanding notifications of shortages and sharing relevant information regarding possible price gouging with the Department of Justice.
ASA President Jerry A. Cohen, M.D. expressed ASA’s support for the Administration’s executive order:
"On behalf of our physicians and patients, we praise President Obama for his bold action in addressing the growing drug shortages pandemic. In particular, we praise the Administration for including many of the recommendations we proposed with other members of the Drug Shortages Summit. We look forward to continuing to work with the Administration to ensure our physicians have the medications they need to care for patients. "
Over the course of the last year, ASA has actively led efforts to deal with the drug shortage issue including co-convening a Drug Shortage Workgroup Summit with 20 relevant stakeholders--providers, drug manufacturers and other relevant organizations. Therefore, ASA was encouraged to see that in today’s executive order the Administration chose to adopt several of the recommendations found in the Drug Shortage Workgroup Summit’s report.
Read the executive order.
Read the Economic Analysis of the Causes of Drug Shortages.
Read the Review of FDA's Approach to Medical Product Shortages.
Learn more about ASA’s action regarding drug shortages.