Enduring drug shortages for certain products, along with sporadic drug recalls, have interrupted access to safe, effective, high-quality pharmaceutical products for U.S. consumers. Lawmakers and regulators subsequently are addressing the trend. They’re starting with symptoms of the larger problem: the global pharmaceutical supply chain and quality management.
As of 2020, for example, 74% of all registered facilities that manufacture active pharmaceutical ingredients (APIs) and 54% of registered facilities that make finished dosage form (FDF) human drug products were outside the United States. This lay of the land formed as 327 new shortages of drugs were identified between 2013 and 2020.
To address such disparities, President Joe Biden’s February 2021 executive order on America’s supply chains focused in part on pharma. Additionally, the Food and Drug Administration in 2022 will prioritize plant inspections of foreign pharmaceutical suppliers, and a newly introduced bipartisan…
Read the full story from the Washington Business Journal.
