U.S. Policymakers Acting to Bolster Drug Supply Chains Amid Critical Shortages
The FDA has the unenviable task of enforcing drug quality standards, Margraf added. “There is a need for comprehensive strategies that balance the need for affordable medications with stringent quality control measures,” he said. “Efforts must promote transparency, accountability, and collaboration among stakeholders with in the pharmaceutical market to ensure the availability of high-quality drugs at reasonable prices.”
An Issue the World Over
The American Society of Health-System Pharmacists has more than 900 drug and dose shortages on its drug shortage list, and the FDA lists more than 200. The number and length of supply disruptions has grown over the last 10 years, according to a March 2023 letter from Congress to FDA Commissioner Robert Califf, MD. “New drug shortages in the country saw a 30 percent increase from 2021 to 2022, posing a risk to public health and national security,” the letter said.
A June 15 news release from Ernst’s office said that 80% of active pharmaceutical ingredients come to the United States from overseas, a national security risk in the event of a national or world crisis.
“This bipartisan legislation will provide the federal government with a better understanding of how our over-reliance on foreign nations for critical drugs threatens our military readiness and creates health risks for Americans,” Peters said in the release.
The move comes on the heels of other policymaker actions to strengthen drug supply chains. Earlier this month, the House Energy and Commerce health subcommittee met to start negotiations to reauthorize the Pandemic and All-Hazards Preparedness Act, which would give the FDA more authority to require that drug manufacturers notify it of supply chain problems.
Drug scarcities are not unique to the United States, with European officials expressing concern about ongoing antibiotic shortages. For example, in mid-June, French President Emmanual Macron said he was seeking to onshore the manufacture of key pharmaceutical products and ingredients to avert future shortages.
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“The pursuit of low-cost production has led to outsourcing manufacturing to countries with lower production costs and less stringent regulatory standards.”
David Margraf, PharmD, PhD
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A June 15 news release from Ernst’s office said that 80% of active pharmaceutical ingredients come to the United States from overseas, a national security risk in the event of a national or world crisis.
“This bipartisan legislation will provide the federal government with a better understanding of how our over-reliance on foreign nations for critical drugs threatens our military readiness and creates health risks for Americans,” Peters said in the release.
The move comes on the heels of other policymaker actions to strengthen drug supply chains. Earlier this month, the House Energy and Commerce health subcommittee met to start negotiations to reauthorize the Pandemic and All-Hazards Preparedness Act, which would give the FDA more authority to require that drug manufacturers notify it of supply chain problems.
Drug scarcities are not unique to the United States, with European officials expressing concern about ongoing antibiotic shortages. For example, in mid-June, French President Emmanual Macron said he was seeking to onshore the manufacture of key pharmaceutical products and ingredients to avert future shortages.
Mary Van Beusekom is a reporter and editor for CIDRAP News. This article is published courtesy of the University of Minnesota’s Center for Infectious Diseases Research and Policy (CIDRAP).
