South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What requirement does the Kefauver-Harris Amendment impose regarding drug advertisements?

1. Advertisements must be approved by the NABP

2. Advertisements can make unverified claims

3. FDA has authority to regulate prescription drug advertisements

4. Advertisements are unnecessary for prescription drugs

The correct answer is: FDA has authority to regulate prescription drug advertisements

The Kefauver-Harris Amendment, enacted in 1962, established significant regulations concerning the marketing and advertising of prescription drugs, particularly enhancing the FDA's oversight in this domain. This amendment requires that any advertisement for prescription drugs must be truthful and not misleading, effectively placing the responsibility on the FDA to ensure compliance. This includes a mandate for the approval and regulation of promotional materials related to prescription medications, ensuring that they provide accurate information regarding the drug's efficacy and safety. The FDA's authority extends to evaluating the claims made in advertisements, reinforcing the safety and efficacy standards that were bolstered by the Kefauver-Harris Amendment. It also ensures that advertisements contain essential information, including potential side effects and contraindications, thereby protecting public health. In contrast, other potential choices do not accurately reflect the specific requirements of the Kefauver-Harris Amendment. The approval by the NABP is not a requirement under this amendment, nor does the amendment allow for unverified claims in advertisements. Additionally, while advertisements for prescription drugs may be less emphasized than those for over-the-counter medications, they are not deemed unnecessary, as they still play a role in the pharmaceutical marketing landscape, albeit under stricter regulations.