Which amendment declared that all new drugs marketed in the U.S. must be proven safe and effective?

The Kefauver-Harris Amendment, enacted in 1962, plays a crucial role in drug regulation in the United States by requiring that all new drugs demonstrate not only safety but also efficacy before they can be approved for marketing. This amendment was a response to public health concerns, particularly following the thalidomide tragedy that highlighted the risks of inadequately tested medications.

Before the Kefauver-Harris Amendment, the standard for drug approval primarily focused on safety, which allowed numerous ineffective drugs to enter the market. The amendment established a more rigorous process for drug evaluation, mandating that pharmaceutical companies provide substantial evidence of both safety and therapeutic effectiveness through controlled clinical trials.

Other legislative acts mentioned each address different aspects of drug regulation and public health. For example, the FDA Modernization Act aimed to streamline the drug approval process and improve access to medications, but it did not set the foundational requirements for safety and efficacy established by the Kefauver-Harris Amendment. The Pure Food and Drug Act of 1906 focused on prohibiting adulterated or misbranded food and drugs but did not require proof of safety or effectiveness. Lastly, the Orphan Drug Act encourages the development of treatments for rare diseases but does not pertain to the overarching standards for all