Letter to Joseph R. Biden, President of the United States - Menendez, Pascrell Lead New Jersey Members Sounding Alarm on Pharmaceutical Supply Chain Hole


Dear President Biden:

We are writing to advise you of a potentially dangerous situation affecting our nation's prescription drug supply and to request your assistance and attention to this emerging threat to our pharmaceutical supply chain. We are grateful for your February 24, 2021 Executive Order on America's Supply Chain (Executive Order 14017) and the resulting one-year reports from each government agency. However, critical packaging components of the pharmaceutical supply chain were not included in the report prepared by the Office of the Assistant Secretary for Preparedness and Response.

Shortages of certain critical raw materials used to package prescription drugs prior to distribution to pharmacies, hospitals, and physician offices have delayed the manufacturing and distribution of certain prescription drugs, many of which are COVID-19 therapeutics. Generally, these raw materials utilized in the packaging process, which are regulated by the U.S. Food and Drug Administration, consist of "board" stock used to manufacture individual cartons for prescription drugs containing the name of the product, along with other essential information, pressure-sensitive label stock used to identify various prescription drugs, ink, varnish, and pharmaceutical lightweight paper. Without these packaging components, prescription drugs cannot be distributed into the supply chain and eventually be prescribed by medical professionals for use by consumers, including vital COVID-19 therapeutics.

Shortages of certain raw materials used to manufacture these products have resulted in companies choosing to allocate the sale and distribution of these products to their customers who manufacture pharmaceutical packaging components based on a percentage of what the customer previously consumed. Thus, if a certain allocation is based on 80 percent of what the packaging component supplier consumed in 2021, that would result in a 20 percent shortfall of pharmaceutical packaging components, resulting in a delay to the manufacturing and distribution of certain prescription drugs until these raw materials eventually become available.

We urge you to work with manufacturers of board and pressure-sensitive label stock to afford the highest priority for the sale and distribution of these packaging components specifically for the manufacturing of cartons and labels for prescription pharmaceutical uses. At this point, the highest priority should be the manufacturing and distribution of potentially lifesaving COVID-19 therapeutics.

Thank you for your consideration and we look forward to working with you on this critical matter.