Which act requires new drugs to be shown safe before marketing?

The correct answer is the 1938 Food, Drug, and Cosmetic Act, as this legislation established the requirement that new drugs must be proven safe before they can be marketed to the public. Prior to this act, the Food and Drug Act of 1906 only ensured that drugs were accurately labeled, but it did not mandate any testing for safety or efficacy.

The 1938 Act introduced more comprehensive regulations concerning drug safety and specifically required manufacturers to provide evidence of safety to the FDA before a drug could be sold. This marked a significant step forward in consumer protection and pharmaceutical accountability, as it meant that drugs needed to undergo rigorous testing to assess potential side effects and toxicity.

The 1951 Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act differentiated prescription drugs from over-the-counter drugs but did not establish safety requirements for new drugs. The 1990 Omnibus Budget Reconciliation Act primarily focused on pharmacy practice standards, including patient counseling and medication reviews, rather than the safety evaluation of new drugs. Therefore, it is the 1938 Food, Drug, and Cosmetic Act that stands as the landmark legislation requiring the demonstration of safety for new drugs before marketing.