The Fact
In 1997, the U.S. Food and Drug Administration issued guidance explaining how prescription-drug companies could satisfy the "adequate provision" requirement for consumer-directed broadcast advertising. Instead of placing complete labeling information inside a television or radio ad, companies could provide the major risk statement and direct consumers to additional sources of detailed information. FDA later finalized broadcast-ad guidance in 1999.
What This Means
The rules governing prescription-drug advertising changed in a way that made broadcast product-claim advertising more practical. The rapid expansion of televised prescription-drug advertising occurred in the years that followed.
Sources
- U.S. Food and Drug Administration, Consumer-Directed Broadcast Advertisements guidance; Donohue JM, Cevasco M, Rosenthal MB. A Decade of Direct-to-Consumer Advertising of Prescription Drugs. N Engl J Med. 2007;357:673-681; related historical reviews.