Shortages of critical drugs in the U.S. resulting from supply chain issues are occurring more frequently, and having devastating impacts on patient care and health.
Last year, there were shortages of nearly 300 medications — a 30 percent spike from 2021. Currently, there are nearly 140 active drug shortages, forcing doctors and families into impossible decisions to use less effective alternatives, stretch doses or even delay treatments as chemotherapy and other crucial drugs run low.
A study from May 2023 shows more than 90 percent of the major cancer centers nationwide are being impacted by chemotherapy drug shortages. Patients with ADHD have struggled to access Adderall, a treatment key to their daily lives, for nearly a year. Drugs essential to hospital care, like local anesthetics bupivacaine and lidocaine, have also had persistent supply issues. Last winter, even over-the-counter flu and children’s cold medications were difficult to get due in part to an increase in demand spurred by spikes in flu and RSV cases.
Re-authorizing the Pandemic and All-Hazards Preparedness and Response Act (PAHPA) and including needed authorities for the Food and Drug Administration (FDA) is a timely opportunity for Congress to prevent drug supply chain issues and alleviate shortages.
The FDA has been instrumental in mitigating drug shortages and ensuring Americans retain access to critical and life-saving drugs despite having limited tools to do so. Last year, the FDA successfully worked with drug manufacturers and stakeholders to prevent 222 drug shortages by using alternative drug sources, expedited reviews, data collected from manufacturers voluntarily on inventory and production plans, early notifications of discontinuances in manufacturing, and other regulatory flexibilities.
Yet, the agency could be even more effective with additional reporting authority over drug manufacturers.
PAHPA reauthorization is the most efficient way to get the FDA the tools it needs to monitor the drug market and get ahead of possible shortages. While the Senate HELP Committee has already included new authorities for the FDA in its bipartisan version of PAHPA, the same cannot be said for the House, where opposition to the FDA authorities by Republican members of the committee led to a version that excludes FDA authorities.
The pandemic exposed weaknesses in the medical supply chain as production temporarily halted in manufacturing facilities, international trade of pharmaceutical products was interrupted, and demand for drugs used to treat COVID-19 patients, such as sedatives and pain medications, increased. These supply chain vulnerabilities put the U.S. at risk of shortages. The U.S. pharmaceutical market relies heavily on foreign production, predominantly sourcing both key drugs and critical raw materials from China and India: 80 percent of the facilities that manufacture the active ingredients that give drugs their intended effect operate outside of the U.S. The lack of robust domestic sourcing leaves our supply chain susceptible to fluctuations in global trade.
Consolidation among drug manufacturers also threatens drug supply chains, by discouraging the production of less profitable drugs, thus limiting patients’ access to them. Consolidation among health care systems has also squeezed manufacturers out of the market. Both large health networks and smaller hospitals through group purchasing organizations award sole-source contracts to purchase drugs in bulk in exchange for steep discounts from manufacturers.
Extreme weather events, which are occurring more frequently due to climate change, are a threat to the drug supply chain and put manufacturing facilities at risk. Just last month, a tornado hit a North Carolina Pfizer plant’s warehouse storing hospital drugs like morphine. Fortunately, despite initial concerns, that event is not expected to cause any significant impact on drug supply, in part due to efforts by the FDA to secure additional sources and manufacturers for those drugs.
Another significant vulnerability in the drug supply chain is the lack of full visibility from a drug’s building blocks to it getting in the hands of consumers. Without transparency, the FDA is limited in its ability to ensure a safe and reliable drug supply. Expanding FDA’s reporting and notification authority, as Senate HELP’s bipartisan version of PAHPA does, to include requiring drug manufacturers to notify the FDA when they are not able to meet the demand for a drug — whether because of spikes in demand, export restrictions or other supply-side issues — and provide the FDA with information on their suppliers of raw ingredients, including active ingredients, would improve gaps in the drug supply’s visibility. Moreover, it will help identify critical supply gaps that can be mitigated through stockpiles, standby production facilities, or other measures.
Strengthening the FDA’s capacity to tackle drug shortages is central to a multi-pronged approach to improving drug supply resiliency, protecting the health of Americans, and ensuring the country is prepared to tackle future health threats that are inevitably coming. Whether expanded FDA authorities remain in the final reauthorization of PAHPA or are considered under separate legislation, it should be without question that part of the United States’s strategy on pandemic preparedness include building a resilient drug supply chain ready to meet the needs of the public.
Marquisha Johns is an associate director for Public Health Policy at the Center for American Progress.