Transcript Product Claim Ads

 Three
main types of DTC Ads.
› Product Claim Ads – these ads name the drug and the
condition it treats, and talk briefly about its benefits and
associated risks.
› Reminder Ads – this type of advertisement provides the
drug’s name, but doesn’t mention the drug’s uses.
› Help-seeking Ads – describes a specific disease or
condition, but stop short of recommending or suggesting
a specific drug.
Source:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm
 Quick
Facts and Regulatory
Agencies.
› The United States is one of only two developed
nations that currently allow DTC pharmaceutical
advertising, with New Zealand being the
second.
› The FDA’s Division of Drug Marketing,
Advertising, and Communications (DDMAC) is
responsible for ensuring that all prescription drug
promotion provided by drug firms is truthful,
balanced, and accurately communicated.
Source:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm
 Requirements
advertisers.
placed upon DTC
› Product claim ads are required to provide full
disclosure of a drug’s known risk information.
• In print ads this information can be found near the
end in a font so small its difficult for the eye to
read.
• TV ads are allowed the liberty to highlight only the
main points so long as the location on where to
obtain the complete information is disclosed to the
targeted consumer.
Source:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm
•
Doctors are being
influenced by the perks
offered by major
pharmaceutical
manufacturers and reps.
•
These representatives are
offering doctors free
samples when they visit
them and when they are
not, they are sending
invitations to expensive
and elegant
“informational” events.

Pharmaceutical Companies treat Doctors to extravagant
dinners and all expense paid junkets for the purpose of
influencing their decisions in which drugs to prescribe. This has
driven the patients cost up in some cases by as much as $160
per day when prescribed the newer more expensive drugs.

Pharmaceutical Companies give Doctors all expenses paid trips,
the only requisite of the Doctors is to agree to listen to several
lectures detailing new market offerings by the hosting company.
In a research study conducted, this type of marketing influenced
Doctors choice of prescription drugs prescribed by as much as
200%
Source:
http://www.scu.edu/ethics/publications/submitted/morreim/prescribing.html


In 1969, FDA issued final regulations governing drug
advertising at 21 C.F.R. § 202.1.47
Under these regulations, advertisements must have four basic attributes:
› (1) - they cannot be false or misleading
› (2) - they must present a “fair balance” of information about the
risks and benefits of using the drug
› (3) - they must contain “facts” that are “material” to the
product’s advertised uses
› (4) - in general, the advertisement’s “brief summary” of the drug
must include every risk from the product’s approved labeling.
Source:
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252
005.pdf

From 1969 to early 1997 advertisers and drug
companies relentlessly championed against
the disclosure regulations.
› Given the short timeframe, often 60 seconds or less, it
was considered too cumbersome to include all the
required information within the ads.
› In regards to print ads, the space limitations posed the
same drawback and deterrent.
Source:
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252
005.pdf

According to Jon Swallen, a research analyst at TNS Media
Intelligence, pharmaceutical companies spent about $4.7
billion in magazine and television advertising in 2008.
›

This money could be diverted to research and development of new
drugs, and assist in making existing drugs more effective
However, many peoples livelihoods depend on this ad
revenue.
›
In a period of one year (2008), magazines as a group would have lost roughly $210
million, or 0.8% of the approximately $25 billion in total ad revenue it took in for the
year, had there been a moratorium on DTC print media.
›
Similarly, television outlets would have lost some $423 million, or 0.7% of its $60 billion
in total ad revenue for the year.
Source:
http://www.time.com/time/business/article/0,8599,1876679,00.html

In 1997, the FDA issued draft guidance to advertisers and
pharmaceutical companies on how to best comply with the
regulations in place since 1969.

The guidance was finalized in 1999, expanded in 2004 to
include print media, and outlined the following key points.
› Required DTC broadcast advertisements to include the
advertised products most important risks (referred to as a “major
statement” by the FDA.
› For print ads, a “brief summary” was now required by law to be
included.
Source:
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252
005.pdf
In 2007, the President signed into law the
Food and Drug Administration
Amendments Act.
 The FDAAA gives FDA the authority to “.
. . require the submission of any television
advertisement for a drug . . . not later
than 45 days before dissemination of the
television advertisement”

Source:
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/
RL3285303252005.pdf
Sponsors have the option of submitting any
proposed prescription drug television ad to
FDA for advisory review before publicly
disseminating the ads.
 In this way, sponsors can benefit from FDA’s
input on whether or not ads are accurate,
balanced, and non-misleading before they
disseminate the ads.

Source:
http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/R
L3285303252005.pdf
•
Are the regulations in
place enough?
•
Do they do enough to
ensure the safety and
general well being of the
intended audience?
•
Tobacco is known to be
a carcinogen, but the
population was once
bombarded with print
and media ads for these
products, also regulated
by the FDA.

In 1970 – congress passed law ending
Tobacco advertising on radio and
television.

Heavily medicated public = heavy profits

Less money spent on advertising means
more available funding for R & D.
FDA. "Keeping Watch Over Direct-to-Consumer Ads."
FDA.gov. Food and Drug Administration, 10 May 2010.
Web. 05 Nov. 2012.
 Gregory, Sean. "Are Direct- To-Consumer Drug Ads
Doomed?" Time.com. Time Warner, 04 Feb. 2009. Web.
05 Nov. 2012.
 Morreim, E. Haavi. "Prescribing Under the Influence." Drug
Company Gifts to Doctors. Santa Clara University, 2012.
Web. 06 Nov. 2012.
 United States of America. Congressional Research Service,
The Library of Congress. Domestic Social Policy Division.
Direct-to-Consumer Advertising of Prescription Drugs.
By Donna U. Vogt. Washington D.C.: Congressional
Research Service, 2005. Www.law.umaryland.edu.
University of Maryland, 03 Mar. 2005. Web. 05 Nov.
2012.
