Believing FDA's Assurance of Quality Pharmaceutical Products Can Be Dangerous to Your Patients' Health.

Abstract

The Food and Drug Administration (FDA) exists to protect US consumers. However, while drug manufacturing has shifted dramatically to developing countries like India and China, the FDA first silently followed a "trust and not verify" strategy with virtually no overseas inspections until overwhelming evidence of patient harm had occurred. The implementation of the Generic Drug User Fee Act helped alleviate this problem, but the issue recurred after the COVID-19 pandemic set the FDA far behind in foreign inspections. Regardless, the FDA has never attained parity in inspection frequency and rigor in these countries versus the United States. The FDA still over relies on reports of adverse events, whistleblower reports, and independent laboratory findings to prompt an investigation. When serious issues are found in a manufacturing plant, they redact the products manufactured there so clinicians and patients are unprotected. This has directly harmed US citizens, exposed them to cancer-causing agents, and provided products without the expected benefits. When rates of adverse events were recently compared by manufacturer location, they were found to be markedly higher for manufacturers in emerging countries than advanced countries, especially when a drug's patent has been expired for a longer time. Clinicians may be dismissive of patients claiming that a new version of a generic drug isn't as effective as their previous one or is causing new adverse events, but that could be the case. Healthcare professionals should report these cases to the FDA to raise awareness of potential issues.