Both Democratic and Republican legislators have proposed laws in Congress aimed at reducing drug shortages and protecting US security by onshoring medication manufacturing, especially for products currently originating in China, Homeland Preparedness News reports.
"Insufficient visibility into drug supply chains, economic drivers, and increased demand have made it difficult for healthcare professionals to treat patients due to drug shortages," said David Margraf, PharmD, PhD, pharmaceutical research scientist at the Resilient Drug Supply Project (RDSP), part of the University of Minnesota's Center for Infectious Disease Research and Policy (CIDRAP), publisher of CIDRAP News
"Advanced manufacturing capabilities to produce high-quality critical drugs on or near US soil, and the information needed to monitor supply chain vulnerabilities to anticipate possible shortages, should be incentivized to reduce reliance on foreign countries and prevent shortages," he added. "Our goal at RDSP has been to map and offer such policy advice to remedy shortages that have plagued patients for years."
Senate committee report spurs action
On March 28, several House members launched the bipartisan Domestic Pharmaceutical Manufacturing Caucus. Cochairs Georgia Rep. Buddy Carter (R), Michigan Rep. Elissa Slotkin (D), Pennsylvania Rep. Chrissy Houlahan (D), and Florida Rep. Gus Bilirakis (R) say they will push legislation that adds incentives for more US production of essential drugs to reduce reliance on foreign foes, prevent shortages, and ensure a flow of medications for public health emergencies.
On March 27, Washington state Rep. Cathy McMorris Rodgers (R), chair of the House Energy and Commerce Committee and lead investigator into the country's drug shortages and the Food and Drug Administration's (FDA's) response to the problem, wrote a letter to FDA Commissioner Robert Califf, MD, on the issue.
McMorris Rodgers and her colleagues called for Congress, the executive branch, academia, and industry to collaborate on securing supply chain visibility to identify vulnerabilities, invest in quality systems and advanced-manufacturing technology, and ensure supplier diversification through strategic onshoring of critical generic drugs that are regularly in shortage.
The legislators have asked Califf to answer questions by today on such issues as the country of origin for the manufacture and processing of each drug in shortage and whether the medication is approved under the Federal Food Drug and Cosmetic Act. They also want to know how data are used to prioritize foreign plant inspections, as well as specific information on ongoing shortages of albuterol, amoxicillin, acetaminophen, and ibuprofen, according to Homeland Preparedness News.
"New drug shortages in the country saw a 30 percent increase from 2021 to 2022, posing a risk to public health and national security," McMorris Rodgers wrote, quoting from a March 2023 report from the US Senate Committee on Homeland Security & Governmental Affairs, chaired by Michigan Sen. Gary Peters (D).
In that report, Peters and his colleagues wrote, "Both the pharmaceutical industry and the federal government, including the [FDA], lack the information needed to effectively detect and prevent shortages. Most significantly, this updated report found that our continued overreliance on foreign suppliers for the key materials needed to make critical drugs, primarily those in China, remains an unacceptable national security risk."
While the FDA works with manufacturers and other supply-chain stakeholders to prevent or reduce these shortages and has asked Congress for the authority to access more information on the supply chain, the agency may not be using the power it already has to take more action, the report said.
"Both the pharmaceutical industry and the federal government, including the [FDA], lack the information needed to effectively detect and prevent shortages.
"The FDA has not publicly released any summary of these reports in an aggregated way that may inform policy makers and provide the data Congress and others need as we examine ways to make sure the supply chain for drugs Americans need is secure," the authors wrote.
Recently introduced legislation
- Recent legislation to shore up the US drug supply includes a bipartisan bill sponsored by Florida Sen. Marco Rubio (R) and Massachusetts Sen. Elizabeth Warren introduced on March 29. The bill seeks to enact recommendations from a September 2021 US Department of Defense Office of Inspector General report addressing drug supply chain deficiencies, which they say are as important to national security as semiconductors, microelectronics, and rare-earth minerals.
- In January, Rubio also sponsored the bicameral Medical Manufacturing, Economic Development, and Sustainability Act, which would provide incentives for the onshoring of medical manufacturing and the manufacturer of medical products in economically depressed areas of the country.
- That same month, Texas Rep. John Carter (R) and Delaware Rep. Lisa Blunt Rochester (D) proposed the Essential Medicines Strategic Stockpile Act of 2023. The bill would update the Public Health Service Act to enable the stockpiling of generic medications and require the Department of Health and Human Services to draw up a list of the 50 generic drugs needed in public health emergencies. "When a parent goes to the store and sees an empty shelf where amoxicillin should be, the emergency stockpile of essential medicines is no longer an idea, it's a life-saving measure," Carter said.
Margraf said the bipartisan efforts to reduce drug shortages and onshore medication manufacturing are welcome. "It is essential to protect US security and ensure stable supplies of essential drugs," he said. "The reliance on foreign suppliers poses substantial risk to public health and national security."