All medications – over the counter and prescription – have side effects. Patients assume some level of risk whenever they take a drug, but they do not have to accept debilitating, life-altering harm.
How Are Drugs Regulated?
Pharmaceutical companies have a duty to consumers to take necessary steps to ensure their products are safe for use. The Federal Food and Drug Administration (FDA) oversees the industry, demanding compliance with rigorous research, testing, reporting, manufacturing, and labeling requirements. Unfortunately, companies do not always satisfy these commitments, which can have devastating results for patients. When a drug manufacturer or the FDA recognizes a problem, a drug recall may occur. Sometimes market withdrawals prevent public harm, if they pull a contaminated product out of the commerce stream before it reaches consumers. However, more often, drugs are recalled after reported harm from sick patients.
