Regulatory Affairs Certification (RAC) Practice Exam

The Federal Trade Commission (FTC) has primary authority over which of the following?

1. Over-the-counter (OTC) drug advertising.

2. Prescription drug advertising.

3. Generic drug advertising.

4. Restricted medical device advertising.

The correct answer is: Over-the-counter (OTC) drug advertising.

The Federal Trade Commission (FTC) has primary authority over the advertising of over-the-counter (OTC) drugs because its mandate is to protect consumers from deceptive or misleading advertisements in commerce, including the healthcare sector. OTC drugs are available for purchase without a prescription, making their advertising subject to FTC regulations ensuring that such advertisements are truthful and not misleading. Prescription drug advertising is primarily regulated by the Food and Drug Administration (FDA) due to its role in ensuring the safety and efficacy of pharmaceuticals before they reach the market. The FDA has specific guidelines for prescription drug advertising, including the requirement for risk information to be clearly presented. Similarly, generic drug advertising falls under the jurisdiction of the FDA, which controls how drugs are marketed, ensuring that the generic products are adequately represented in a way that is compliant with federal laws concerning drug safety and efficacy. Restricted medical device advertising also typically falls under the authority of the FDA. While the FTC monitors general advertising practices, the specifics regarding the promotion of medical devices — especially those that are classified as restricted — are closely overseen by the FDA to ensure that the devices meet regulatory standards and that any claims made in their advertising do not mislead consumers. Thus, the answer is rooted in the FTC's regulatory scope and its focus on