The Biden administration is investing $35 million in domestic production of sterile injectable medicines to address persistent drug shortages in the United States. This initiative is part of broader efforts by the White House to strengthen national supply chains, including the use of the Defense Production Act to boost domestic manufacturing of essential medicines, as detailed in a White House fact sheet released on November 27.
The investment comes amidst rising shortages in various drug categories, as highlighted in a July 2023 survey by the American Society of Health-System Pharmacists. The survey indicated 309 active, ongoing drug shortages in June and July, marking the highest number in nearly a decade.
Douglas Hoey, CEO of the National Community Pharmacists Association, noted that the shortages predominantly affect generic drugs. The debate on how to address the shortage involves differing perspectives, with some stakeholders advocating for a diversity of suppliers and manufacturers, while others focus on drug pricing issues.
A March report from the Senate Homeland Security and Governmental Affairs committee pointed out that the geographic concentration of raw drug ingredients in countries like China and India poses transparency and quality control risks for U.S. drug manufacturers. The Administration for Strategic Preparedness and Response estimates that 90% to 95% of generic sterile injectable drugs critical for acute care in the U.S. rely on key materials from these countries.
The Biden administration’s approach includes funding increases in domestic manufacturing as a solution to supply chain problems in pharmaceuticals, building upon measures initiated in 2021.
However, experts like Michael Ganio, VP of global resource development and consulting at the American Society of Health-System Pharmacists, argue that expanding domestic production is not a singular solution. Ganio cites past drug shortages involving medicines produced in the U.S. as evidence that onshoring operations may not fully resolve the issue. He emphasizes the need for greater transparency in the pharmaceutical supply chain.
Hoey also points to the role of pharmacy benefit managers in the drug manufacturing and supply chain issues, highlighting their significant market influence and impact on drug pricing.
The recent funding from the Biden administration is seen as a positive step, but Hoey suggests that more substantial investment and policy changes are necessary, particularly in how prescription drugs are paid for in the U.S. He stresses the need for an overhaul in drug pricing, considering the role of pharmacy benefit managers and the economic factors influencing drug availability.
The focus on sterile injectables by the Biden administration, a category with limited manufacturers due to stringent sterility requirements in the U.S., is crucial. Hoey emphasizes the importance of ensuring a robust supply of essential injectables like normal saline, used in numerous medical procedures.
For generic drugs, which face fewer production restrictions, Hoey notes that supply issues often stem from economic factors or market demand. He highlights the necessity of addressing both the supply and demand aspects to mitigate drug shortages effectively.
To further these efforts, the Department of Health and Human Services is set to appoint a supply chain resilience and shortage coordinator. This role will focus on strengthening critical medical product and food supply chains and addressing related shortages. Additionally, the Department of Commerce and the Administration for Strategic Preparedness and Response are collaborating to identify and resolve weaknesses in the U.S. public health industrial base supply chain, with priorities including influenza vaccine production, essential medicines, and high-impact biological medical countermeasures.
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