Science of detecting, assessing, and preventing adverse effects of pharmaceutical products
Pharmacovigilance is the science and practice of monitoring pharmaceutical products after they reach the market to detect, assess, understand, and prevent adverse effects. It encompasses the collection and analysis of adverse event reports, signal detection from real-world data, risk management planning, and regulatory action when safety concerns emerge.
The pharmacovigilance system is supposed to serve as the safety net that catches problems missed during clinical trials, which typically involve limited populations over limited timeframes. In practice, the system is compromised by multiple structural weaknesses. Adverse event reporting is voluntary and massively underreported. Pharmaceutical companies control much of the data. Regulatory agencies are understaffed and subject to industry pressure.
The FDA's approach to pharmacovigilance has been criticized as reactive rather than proactive. The agency has been slow to issue warnings or withdraw dangerous drugs, sometimes taking years after safety signals emerged. The GAO has repeatedly found that the FDA's post-market surveillance capabilities are inadequate. Whistleblowers within the FDA, including former drug safety officer David Graham, have testified that the agency's culture prioritizes drug approval over safety monitoring — a structural bias that puts pharmaceutical industry interests above patient protection.
