Why do government agencies regulate the safety and effectiveness of medicines?

Government agencies regulate the safety and effectiveness of medicines to protect public health by ensuring that the benefits of a drug outweigh its potential risks. Because all medications carry some degree of risk—including adverse reactions, toxic impurities, or potential for abuse—regulatory oversight is essential to maintain a favorable risk-to-benefit ratio for the population.123

These agencies, such as the Food and Drug Administration (FDA) in the United States, oversee the entire lifecycle of a drug, including:

• Premarketing Approval: Requiring rigorous scientific studies and clinical trials to verify that a new drug is both safe and effective before it reaches the market.134
• Surveillance: Monitoring drugs already in use to identify rare or serious side effects that may not have appeared during initial testing.34
• Quality Control: Ensuring that manufacturing methods are sound and that products are not adulterated, fake, or counterfeit.2
• Labeling and Advertising: Preventing false or misleading claims to ensure patients and physicians have accurate information.3

Historically, regulations have often been strengthened following drug-related catastrophes, such as the thalidomide crisis, which underscored the ethical necessity of protecting the public from preventable harm.5