Direct-to-Consumer Advertising

Flashcard History's post.

Before 1980, there was no such thing as Direct-to-Consumer Advertising (DTCA) of prescription drugs.

The key phrase in the Regulations that they took advantage of was that ads require a brief summary unless there are “adequate means” of disseminating the full prescribing information.

So FDA crafted a set of rules that would be considered ”adequate means.” 

But in 1981, a few drug companies experimented with ads. The reaction of the Food and Drug Administration (FDA) was to impose a moratorium on all DTCA so it could research the issue.

After a few years, the moratorium was lifted, but essentially it only allowed print advertising in magazines. It took 14 more years before the FDA issued rules on TV advertising.

Why print and not TV?
The answer is in the fine print — the package insert or the full prescribing information (the brief summary).

So in the early days, if there was no brief summary, no drug ads were allowed on TV.
In 1995, during Democrat President Bill Clinton’s administration, the FDA devised a scheme to justify DTCA.

The key phrase in the Regulations that they took advantage of was that ads require a brief summary unless there are “adequate means” of disseminating the full prescribing information.

So FDA crafted a set of rules that would be considered ”adequate means.” The ads would have to have four components: a toll-free number for people to call to obtain the PI (prescribing info);
a reference to see a magazine where they were concurrently running a print ad (so the person could read the accompanying brief summary); a Web site where the PI could be found; and lastly, instructions to ask your doctor or pharmacist for more complete information.

https://www.everydayhealth.com/…/a-history-of-drug-ads-on-…/