At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with sickle cell disease. While this is good news for children in the U.S. born with this illness, the FDA’s approval may also benefit thousands of children beyond the U.S. border. About 70% of countries around the world have underdeveloped regulatory drug approval processes. So most rely, in whole or in part, on reviews conducted by agencies that the World Health Organization has designated as WHO-Listed Authorities. These authorities include 39 regulatory agencies from 38 countries plus the European Union that meet the highest international regulatory standards for experimental drugs. I am a pharmacist and clinical pharmacologist who has researched the FDA’s funding mechanisms and oversight of prescription and over-the-counter drugs for nearly 30 years. Since the 1980s, this model has been a win-win proposition for the countries, their citizens and the pharmaceutical companies. However, some recent changes at the FDA could hurt international confidence in their objectivity and rigor. An arduous process WHO-Listed Authorities oversee the approval of several types of experimental drugs, including vaccines, standard small-molecule drugs such as aspirin, diuretics, statins and antibiotics, and injectable large-molecule drugs…
Healthcare
FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation
Source: The Conversation Health — CC BY-ND 4.0