Seems like you’ve gotten loads of feedback on your second question, so I’ll endeavor to give the skinny on the first.
I’m a Regulatory Affairs manager for a Medical Device company, so this is essentially how I whittle away my days.
It is legal for pharmaceutical companies to market their products directly to consumers (DTC), provided that the marketing items meet certain requirements stipulated in the Code of Federal Regualtions. Since the FDA considers “any statements, claims…” etc. to be labeling, and since the FDA has strict requirements for labeling content, the FDA made some laws governing DTC advertising of prescription pharmaceuticals.
Let me summarize:
-DTC ads have to provide consumers with either an 800 number or other means of obtaining “additional” information (i.e. a package insert). Telling the millions to “ask your doctor” seems to satisfy this requirement.
-DTC ads for prescription drugs have to balance claims of effectiveness with truthful and accurate disclosure of side effects. In other words, if you say that Viagra helps sustain erections, you’d also have to say that it could raise blood pressure. If you don’t state any claims in your ad, then you don’t need to mention side effects. Pointing consumers to “ask the doc.” is one way around having to list out side effects publicly. This way the pros and cons can be discussed in private and with personal emphasis.
-The most obvious reason of all for the “ask you doc” statement is that this is a prescription drug and is not available over the counter.
There are loads of other requirements, including the size of text and logos to be present in the ad, but I think these get to the heart of your question.
If you’re having trouble sleeping, check out FDA’s Center for Drug Evaluation and Research at http:\www.fda.gov\cder