Final answer:
The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 is the federal statute that requires drugs to prove they are safe and be properly labeled. This law ensures safety and efficacy but can also delay access to new treatments and burden companies with the cost of extensive testing requirements.
Step-by-step explanation:
The federal statute that requires drugs to prove they are safe and properly labeled is the Federal Food, Drug, and Cosmetic Act (FD&C Act), initially passed in 1938. This cornerstone regulation underwent numerous amendments to ensure that drugs sold in pharmacies across the United States meet the highest standards for safety and efficacy. Drug makers must conduct extensive testing, which can last for years, before their products can access the market. The FD&C Act also mandates accurate labeling and marketing, including the need for a fair balance in advertisement between the benefits and the risks of the drug.
While the public generally benefits from such regulations because they are protected from unsafe drugs, there can be anonymous losers in this system. These are often patients with urgent needs for new treatments that are delayed by the lengthy approval process, or companies—especially smaller enterprises—that struggle to bear the high costs associated with the extensive testing requirements.
The Pure Food and Drug Act of 1906 is another landmark law that paved the way for later legislation by requiring drug makers to list ingredients on products, setting the stage for the development of modern food and drug laws, including the FD&C Act.