South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What was a result of the Kefauver-Harris Amendment of 1962?

1. Drugs can be marketed without FDA approval

2. Manufacturers must prove safety and effectiveness

3. No more requirements for reporting adverse drug reactions

4. Creation of orphan drug status for rare diseases

The correct answer is: Manufacturers must prove safety and effectiveness

The Kefauver-Harris Amendment of 1962 resulted in manufacturers being required to prove both the safety and efficacy of drugs before they could be marketed. This amendment was a significant change to the law, as it tightened the regulations surrounding drug approvals. Prior to this amendment, drugs only needed to be shown as safe, and it was not mandatory to demonstrate that they were effective for their intended use. The law was enacted in response to concerns over the thalidomide tragedy, where a drug that was marketed as safe caused serious birth defects. Thus, the amendment sought to ensure that all new drugs not only had a safety profile but also provided evidence that they were effective for their claimed purposes. This requirement fundamentally changed the landscape of pharmaceutical regulation and has remained a crucial part of the approval process by the FDA. The other choices do not accurately reflect the outcomes or stipulations introduced by the Kefauver-Harris Amendment. Options concerning marketing drugs without FDA approval, the elimination of requirements for reporting adverse drug reactions, and the creation of orphan drug status involve different aspects of drug regulation and are not direct results of this specific amendment.