Direct-To-Consumer Advertising

Question 1

Prescription drug advertising is regulated by…

Answer 1

the FDA. This was included in the Kefauver-Harris Amendment of 1962.

Question 2

OTC drug advertising is overseen by…

Answer 2

the Federal Trade Commission (FTC)

Question 3

FDA requires an ad to have 3 elements:

Answer 3

1) the name of the drug (brand and generic)
2) at least one FDA-approved use for the drug
3) the most significant risks of the drug
* Any false or misleading statements could be considered misbranding

Question 4

The advertised price of a prescription drug shall be in effect for:

Answer 4

The period of time stated in the ad

Question 5

What are acceptable methods of advertising professional services to the public?

Answer 5

newspapers, periodicals, professional directories, radio, TV (Note: When advertising prices, any additional charges for related services that are an integral part of the overall service being offered must also be included in the advertisement)

Question 6

Is there any record-keeping requirement related to advertisements?

Answer 6

Yes

Question 7

Exact copies of advertisements must be kept by the licensee releasing such advertisements for at least how long after their last appearance?

Answer 7

1 year (should be kept in the appropriate medium in which they were released)