Federal Bill Reintroduced to Strengthen Pharmaceutical Supply Chain
Senators Elizabeth Warren and Tina Smith have reintroduced the Pharmaceutical Supply Chain Defense and Enhancement Act originally established in 2020.
Senators Elizabeth Warren (D-MA) and Tina Smith (D-MN) reintroduced the Pharmaceutical Supply Chain Defense and Enhancement Act last week. The legislation aims to prioritize avoiding drug shortages and ensuring safety in the pharmaceutical supply chain.
“A strong, reliable supply chain for life-saving drugs will prevent shortages and protect American families,” Warren said in a statement, according to The Hill.1 “This bill will end our over-reliance on foreign countries and give us the tools we need to produce the critical drugs that millions of Americans depend on here at home.”
The bill has 3 main provisions designed to instruct government agencies on the importance of a safe and secure pharmaceutical supply chain in the US. | image credit: lurii / stock.adobe.com
The bill has 3 main provisions designed to instruct government agencies on the importance of a safe and secure pharmaceutical supply chain in the US. First, the bill requires the FDA and secretary of defense to work together and establish a list of drugs that are considered critical to public health and national security. Next, around $1 billion will be allocated to the Biomedical Advanced Research and Development Authority annually for the next 5 years to increase manufacturing capabilities and decrease US production costs.
The new law would also ensure that the Department of Defense, Veterans Affairs, Department of Health and Human Services, and Federal Bureau of Prisons to only purchase American-made drugs funded by each of the respective agencies. Finally, the new law would enact reporting requirements for the Federal Trade Commission as well as drugmakers to report to the FDA annually on the source of ingredients used in their medications.
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“I’m glad to work with Senator Warren on this bill that strengthens our country’s capacity to manufacture critical drugs on US soil and closes gaps in our supply chain,” said Smith.1 “This will help lessen our over-reliance on other countries and make sure Americans can get the drugs they need.”
Finding more affordable and convenient ways to facilitate the production of specific products has been a common yet controversial topic within a slew of various markets’ supply chains. For example, an American shoe company may outsource all of its manufacturing jobs to another country to save money on labor. However, where prescription drugs on the pharmaceutical supply chain are made is less common knowledge compared with other markets.
“We've had shortages because of hiccups in the downstream drug supply, but that's not the primary cause of drug shortages in the US. It does cause some, it can be managed to prevent some, but the primary cause is the upstream side, and yet that's the side that we're most blind to,” said Stephen Schondelmeyer, PharmD, PhD, FAPhA, Professor & Director at PRIME Institute, at the 2024 Developments in Pharmacy Law Seminar.2
In his presentation, titled “Drug Shortages and Building a Resilient Drug Supply Chain: An Examination of National Security Issues and Policy Solutions,” Schondelmeyer discussed the 2 sides of the pharmaceutical supply chain—exactly what Senators Warren and Smith are attempting to improve.
According to Schondelmeyer’s presentation, 100% of downstream supply chain activities for brand-name drugs are conducted in the US, but only 53% for upstream activities. For generic drugs, the upstream-to-downstream disparities are even more complicated with 100% of all upstream supply chain activity conducted outside of the US; mainly in India and China.3
The downstream supply chain, which is more familiar to average individuals than its counterpart, deals with the marketing, packaging, and distribution of prescription drugs. From television commercials for prescription drugs to the FDA’s role in approving them, the downstream supply chain is what most US patients are familiar with.
The upstream supply chain, however, is not as noticeable to average Americans because of its existence in foreign countries. The most important part of the upstream drug supply chain is the use and sourcing of active pharmaceutical ingredients (APIs). The APIs of every pharmaceutical product are what makes up the drugs themselves. And as Schondelmeyer mentioned, an egregious number of prescription drugs’ APIs are being produced overseas, forcing US patients to rely on foreign countries to access medications.
With supply chain issues leading to drug shortages in recent history, industry experts and political leaders like Schondelmeyer, Warren, and Smith are working to address issues within the supply chain. The 3 support the idea that supply chain concerns are a “matter of public health and national security.”1
“This is an unacceptable performance at the market and the drug supply system. We need to do something. We need to change how we operate our drug supply system and encourage this to get better,” concluded Schondelmeyer.2-3
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