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?
handlit33..
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 "...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.
Regards,
-THV
Search Strategy:
pharmaceutical advertising regulations television
personal knowledge of pharma industry
References:
Direct-to-Consumer Advertising
http://www.phrma.org/publications/quickfacts/05.11.2000.189.cfm
STATEMENT BY JANET WOODCOCK, M.D. DIRECTOR, CENTER FOR DRUG EVALUATION
AND RESEARCH U.S. FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH
AND HUMAN SERVICES BEFORE THE SENATE SPECIAL COMMITTEE ON AGING JULY
22, 2003
http://www.fda.gov/ola/2003/AdvertisingofPrescriptionDrugs0722.html Ask your doctor ; For more information; Just how good are drug ads ::
The pharmaceutical industry spent $2.7 billion in 2001 on promotion directly to consumers, more than triple the amount it spent in 1996, according to IMS
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