All articles tagged with #pharmaceutical supply chain
The FDA announced the new PreCheck program to enhance U.S. drug manufacturing by streamlining regulatory processes and encouraging domestic production, aiming to reduce reliance on overseas sources for pharmaceuticals and active ingredients, with a public meeting scheduled for September 30, 2025.
Experts warn that the national shortage of over-the-counter and prescription drugs poses a serious threat to patients' lives and health, with more than 250 active pharmaceutical shortages reported. The overdependence on international suppliers, particularly from India and China, has been identified as a major cause of the shortages, raising concerns about national security and patient safety. Lack of U.S. supervision and transparency in the pharmaceutical supply chain has led to quality issues, putting patients at risk and highlighting the need for congressional action to address the ongoing drug shortage crisis.
The ongoing drug shortage crisis in the United States, particularly in the cancer drug market, is not just a supply chain issue but also a quality-management crisis with life-and-death implications. More than 60% of drug shortages are due to quality issues that disrupt the drug supply, and the FDA's inadequate inspections of both domestic and foreign drug manufacturers contribute to the problem. The reliance on generic drugs, many of which are produced in India and China, further complicates the situation. To address these issues, there is a need to strengthen quality standards, increase funding for manufacturers to upgrade production facilities, and consider reducing reliance on foreign manufacturers.
Drug shortages in the US are approaching record levels, causing delays in treatments for cancer and other life-threatening diseases. Hospitals are struggling to find supplies of essential drugs, including chemotherapy, antibiotics, and even children's Tylenol. The White House and Congress are examining the underlying causes of the faltering generic drug market, which accounts for about 90% of domestic prescriptions. The American Cancer Society warns that delays caused by the shortages could result in worse outcomes for patients. The FDA is seeking authority from Congress to get additional information about the drug manufacturing and supply chain.