FDA’s Hidden Drug Import Waivers

To avoid shortages, the FDA quietly granted exemptions that let more than 20 foreign factories barred for quality problems keep shipping over 150 drugs or ingredients since 2013. Doctors, pharmacists, and Congress were largely kept in the dark—until a single footnote in a 2024 report—about which plants and products were waved through. Bipartisan Senate leaders now demand the agency name the companies and drugs and explain its process. — This spotlights a high‑stakes safety‑versus‑shortage tradeoff being made in secret, forcing a public reckoning over transparency and risk management in America’s generic drug supply.