Before 1980, there was no such thing as DTCA. The times just weren't right. But in 1981, a few drug companies made small forays into this unchartered territory. 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 and the like. But it took 14 more years before the FDA issued rules on how to undertake TV advertising.

Why print and not TV? The answer is in the fine print - the fine print in this case being the package insert or the full prescribing information (you know, that little folded up piece of paper that comes in drug boxes and magically opens into something the size of a towel?). More specifically, the fine print refers to the so-called brief summary.

So in the early days, it was in a nutshell: no brief summary no drug ads on TV. But some of you may recall the early days of TV DTCA during which there were a number of very bizarre TV ads that seemed to say nothing. The prototype were the original ads for Rogaine, which said ?Did you know that Rogaine was minoxidil?? or ?I didn't know that minoxidil was Rogaine.? Unless you already new what Rogaine was, these ads were quite baffling.

This happened because the FDA Regulations stated that a product could advertise itself on TV if it only presented the brand and generic names (both are required) and more importantly there could be no representation of what the drug was for. The regulations were intended to allow drug companies to detail doctors on their products, and since they would then know what the drugs were for, reminders that just called attention to the name would be worthwhile (for the drug companies).

Now we understand the premise behind those seemingly absurd ads. As reminder ads, they were perfectly legal, but they caused a whole lot of confusion, particularly among regular people who might not have known what those drugs were for. All they could do was to sit and scratch their heads. You still occasionally see these ads such as the ones with people surfing through corn fields saying nothing more than ask your doctor about, let's say, Allegra (fexofenadine).

We're coming into the home stretch here, the modern era of DTCA on TV. In 1995, the FDA relented and devised a scheme that they felt everyone could live with. 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, 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 - got that? Well, the drug companies sure did, and the rest, as they say, is history.

Is TV DTCA here forever? Not necessarily. The FDA has been charged with studying the impacts of DTCA and if they or others were to prove significant negative outcomes, it wouldn't take FDA very long to say: ?Remember that stuff about ?adequate means?? well we just decided that the four criteria aren't enough, and you must now include the entire brief summary.? Of course, they could just as easily say the same thing without any data, but even the FDA likes to practice safe regulating! And lastly, Congress could always write new laws precluding TV ads for prescription drugs. Stay tuned.