Final answer:
Before the Federal Food, Drug, and Cosmetic Act of 1938, drugs did not require proof of safety and effectiveness. Substances like morphine and cocaine were found in over-the-counter medicines, and consumers were exposed to the risks of addiction and health issues. Today, the FDA requires extensive testing and continuous monitoring post-approval.
Step-by-step explanation:
Drugs before 1938 did not require proof of safety and effectiveness for approval. The Food and Drug Administration (FDA), established in the early 20th century, initially did not have the authority to mandate such rigorous testing. It wasn't until the Federal Food, Drug, and Cosmetic Act of 1938 that stricter regulations were enacted. Before that, drugs like aspirin were sold without the rigorous testing we see today.
An example that highlights the potential danger of this lack of regulation is the widespread sale of medicines containing harmful substances such as morphine, opium, and even cocaine during the 19th and early 20th centuries. Products like Mrs. Winslow's Soothing Syrup for children contained morphine, and Cocaine Toothache Drops were sold for dental pain relief. Without regulations, consumers faced the risk of addiction and other serious health issues.
Today, drug approval is a comprehensive process where the FDA requires extensive pre-market testing to ensure both safety and efficacy. This process can take several years and involves clinical trials with human participants. Post-approval, there is a continuous monitoring of the drug through pharmacovigilance systems to track long-term safety and effects on different patient subgroups.