Final answer:
The amendment that requires safety and efficacy for drugs is the Food and Drug Administration Amendments Act (FDAAA) of 2007. This act ensures that the FDA regulates drugs effectively but can lead to delays in getting new, potentially life-saving drugs to patients.
Step-by-step explanation:
The amendment to the Federal Food, Drug, and Cosmetic Act that requires safety and efficacy for approval of drugs is the Food and Drug Administration Amendments Act (FDAAA) of 2007. This act was enacted to strengthen the FDA's abilities to regulate drugs, ensuring that they are both safe for consumption and effective for their intended use. Prior to this, the Kefauver-Harris Amendment of 1962 also stressed the importance of drug efficacy, in response to the thalidomide tragedy where a drug caused severe birth defects.
While the FDAAA aims to protect the public from unsafe and ineffective drugs, there are some unintended consequences. These stringent regulations require that a company must diligently test a drug for years before it can be sold in the market. This process can be costly and time-consuming, leading to delayed access to potentially life-saving medications for patients. Therefore, the "losers" in this situation could be patients with urgent medical needs who are waiting for new therapies that are stuck in the regulation pipeline.