ASHP has long advocated for aggressive policy actions to strengthen supply chains and increase transparency in the U.S. and global regulatory system. In 2020, we convened a July 2020 joint summit examining the resilience of the U.S. pharmaceutical supply chain in light of the current state of global pharmaceutical manufacturing. The 2020 summit proceedings, which build on findings from a similar 2018 joint meeting, include a number of findings and recommendations that heavily informed the shortage provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act and that we believe would be valuable to you during the 100-day review required by the EO. To assist in your work on the EO, ASHP has developed the following initial recommendations:
- Require FDA to provide ratings of the quality management processes of drug manufacturers that are predictive of supply chain and manufacturing vulnerabilities.
- Expand the Drug Supply Chain Security Act (DSCSA) to require manufacturers to provide transparency in API sources and manufacturing locations, including locations of contract manufacturers.
- Identify key starting materials, active pharmaceutical ingredients, and finished dosage forms of essential medicines that should have domestic manufacturing capacity to improve the resilience of the U.S. drug supply, and incentivize their production without limiting access to foreign sources of product.
- Improve the functioning of the Strategic National Stockpile (SNS) by:
- Finalizing and regularly updating a list of medicines necessary to respond to potential national-scale public health emergencies, which should be included in the SNS. These drugs may differ from those on the essential medicines list.
- Increasing transparency regarding the specific products and quantities of such products included in the SNS.
- Publishing a clear, nationally consistent process for making requests from the SNS, including publication of contact information for key personnel in each agency that has responsibility for the managing requests and distributions from the SNS.
- Engaging pharmacists and other supply chain experts to develop process for maintaining and refreshing products in the SNS.
- Creating a standard distribution logistics process for medications and related supplies from the SNS, that incorporates feedback from pharmacists and other supply chain experts, including clear expectations for how updates to these processes will be publicized, if needed, in the event of a national emergency.
- Publishing criteria that will be used to prioritize distribution of products from the SNS, including clear expectation for how updates to these criteria will be publicized, if needed, in the event of a national emergency.
- Incentivizing the creation of a private sector reserves of essential medicines not adequately provided by the SNS.
- Finalizing and regularly updating a list of medicines necessary to respond to potential national-scale public health emergencies, which should be included in the SNS. These drugs may differ from those on the essential medicines list.
ASHP is also collaborating with a group of healthcare organizations to develop additional consensus recommendations on a number of supply chain issues, including quality and manufacturing improvement (e.g., reducing contamination in finished pharmaceuticals) and medical supply and medical device supply chain reinforcement. We would welcome the opportunity to meet with you to share these recommendations, which are drawn from our members’ expertise and their real-world experience with utilizing complex, and often delicate, medical supply chains.