Which accomplishment is attributed to the Kefauver-Harris Amendments of 1962?

• A. Mandated efficacy and safety data before a drug could be marketed
• B. Created the Department of Homeland Security
• C. Prohibited prescription drug advertising
• D. Required cosmetic labeling for safety

Answer: (A)

The main idea tested here is that this amendment established that a drug must prove both effectiveness and safety before it can be approved for marketing. In response to the thalidomide tragedy, it required that new medications demonstrate substantial evidence of efficacy as well as safety through well-controlled clinical studies, before the FDA could authorize their sale. This shift gave the FDA stronger authority over drug testing, manufacturing standards (Good Manufacturing Practices), and post-market safety monitoring, including adverse reaction reporting and more transparent advertising. The other options don’t fit: creating the Department of Homeland Security is unrelated to pharmaceuticals, prohibition of prescription drug advertising isn’t what these amendments did, and cosmetic safety labeling was not addressed by these changes.