Which law requires new drugs to be proven safe and effective before approval?

The correct response to this question is grounded in the Kefauver-Harris Amendment, which was enacted in 1962 as an important update to the Food, Drug, and Cosmetic Act. This amendment specifically established the requirement that new drugs must not only be proven safe for use but also demonstrate efficacy for their intended use before they can receive approval from the FDA.

Before the Kefauver-Harris Amendment, the emphasis was primarily on safety, which meant that drugs could be approved without sufficient evidence of their effectiveness. The amendment arose in response to public health concerns and notable drug-related tragedies, such as the thalidomide incident, highlighting the need for stricter drug evaluation.

As a result, the Kefauver-Harris Amendment plays a crucial role in the drug approval process and ensures a higher standard for the marketing of pharmaceuticals by requiring comprehensive clinical trial data for both safety and efficacy.