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Q: Prescription Drug Commercials ( Answered 5 out of 5 stars,   2 Comments )
Subject: Prescription Drug Commercials
Category: Health > Medicine
Asked by: handlit33-ga
List Price: $5.00
Posted: 01 Oct 2004 12:04 PDT
Expires: 31 Oct 2004 11:04 PST
Question ID: 409004
Why do some prescription drug ads on TV not say what the drug is for? 
Is it against the law for them to in some instances?
Subject: Re: Prescription Drug Commercials
Answered By: tar_heel_v-ga on 01 Oct 2004 13:12 PDT
Rated:5 out of 5 stars

Great question and one I wondered myself.  Turns out that in 1997, the
FDA clarified the rules as it relates to direct-to-consumer
advertising.  Prior to 1997, all commericals for medication had to
list the name of the drug and what it was indicated for as well as all
of the side effects that a drug had.  This could lead to massive ads
as any and all reported side effects and contraindications (adverse
interactions with other drugs, pre-existing conditions, etc) had to be
listed.  That is why in print ads for drugs, the back of the ad often
has a full page of small print listing this information.  The rules
changed to where if the name of the drug and the indication of the
drug is not mentioned together (the ailment that it treats) then the
side effects did not have to be listed or reported.  That is why you
see ads where the name of the drug is mentioned, but not what it
treats.  Pharma companies will often do this type of advertising prior
to a full launch of the drug.  After full launch (which can cost, from
beginning to end, anywhere from $250-$500 million), this is when you
start seeing the ads that list the side-effects and contraindications.

There are two types of ads regulated by the FDA,  Reminder and
Product-Claim.  Reminder ads, according to Janet Woodcock, Director,
Center for Drug Evaluation and Research, are ads that "regulated by
FDA and are ads that may disclose the name of the product and certain
specific descriptive information such as dosage form (i.e., tablet,
capsule, or syrup) or price information, but they are not allowed to
give the product?s indication (use) or to make any claims or
representations about the product. They specifically are not allowed
for products with serious warnings (called ?black box? warnings) in
their labeling. The regulations specifically exempt ?reminder? ads
from the risk disclosure requirements because they were historically
designed generally to remind health care professionals of a product?s
availability. Health care professionals presumably know both the name
of a product and its use."

While Product-Claim ads " which generally include both the name
of a product and its use, or make a claim or representation about a
prescription drug. Claims of drug benefits, such as safety and
effectiveness, must be balanced with relevant disclosures of risks and
limitations of efficacy...."

I hope this answers your question.  If you need any additional
information, please let me know.



Search Strategy:
pharmaceutical advertising regulations television
personal knowledge of pharma industry

Direct-to-Consumer Advertising

22, 2003
handlit33-ga rated this answer:5 out of 5 stars
Very good answer, thanks for the quick response!

Subject: Re: Prescription Drug Commercials
From: pinkfreud-ga on 01 Oct 2004 13:53 PDT
Great answer! I had wondered about this myself. There are so many ads
for prescription drugs that show people (often middle-aged and older)
having a wonderful time, vacationing, doing tai chi, smooching each
other, playing with kids, and so on. The ads seem to imply that if you
take this drug you, too, will be good-looking and healthy and athletic
and sexually desireable, etc., but there is no info about the drug
other than "Ask your doctor about Panacea" [or whatever the drug's
trade name is).
Subject: Re: Prescription Drug Commercials
From: kriswrite-ga on 01 Oct 2004 14:07 PDT
I, too, have wondered about this. Thank you for sleuthing out the answer!


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