Direct to You: TV Drug Ads That Make Sense

[FDA]

[1]FDA Home Page [2]Table of Contents

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[U.S. Food and Drug Administration]

Direct to You: TV Drug Ads That Make Sense

by Tamar Nordenberg

The secret's out. The prescription drug Claritin is an antihistamine
for seasonal allergies, new TV commercials reveal. Before August 1997,
the Claritin television ads said little beyond, "At last, a clear day
is here" and "It's time to see your doctor."

Not much to go on in those earlier ads, and the commercials for
Claritin's main competitor, Allegra, were equally unrevealing. Why the
secrecy? Because, by stating the drug's name but not what it was used
for, the ads were exempt from a Food and Drug Administration
regulation that generally requires prescription drug advertisements to
disclose the risks of the medication as well as its benefits. From the
drug companies' perspective, it was impractical to include detailed
risk information in a 30- or 60-second TV spot.

But the so-called "reminder ads" for Claritin and other drugs left
consumers puzzled. "We used to get a tremendous amount of phone calls
saying, 'What is Claritin? What is it for?'" says Alex Giaquinto,
senior vice president for worldwide regulatory affairs for
Schering-Plough Corp., the drug's manufacturer. "You'd be surprised.
We got calls from gynecologists saying patients were asking if they
were candidates for Claritin."

In part because of the consumer confusion and concerns that some TV
and radio advertisements might be misleading, FDA reviewed its
policies on broadcast ads and, in August 1997, issued a draft guidance
for public comment. The new guidance describes how prescription drug
companies can advertise a product directly to consumers on TV or
radio, including the product's use, without scrolling the type of
detailed risk information that accompanies magazine and other print
advertisements.

The makers of Claritin and Allegra soon began airing revised ads.
"Only one tablet means 24-hour, nondrowsy seasonal allergy relief,"
announced the new Schering-Plough commercial.

Not everyone agrees that these "direct-to-consumer" ads are
beneficial. At a 1995 public hearing on consumer-directed advertising,
FDA heard from scientists, drug companies, patient advocates, and
medical professionals. Some objected to direct-to-consumer ads, saying
that they mislead consumers because they don't provide a complete
picture of the drug. Others favored the ads, telling the agency that a
consumer-directed ad can be an important educational tool in an era
when patients want to be more involved in their own health care.

But, says Nancy Ostrove, a public health analyst in FDA's division of
drug marketing, advertising, and communications, "Direct-to-consumer
advertising is not inherently bad or good. It can be useful or
harmful, depending on how it's done."

_Truth in Advertising_

FDA has regulated the advertising of prescription drug products since
1962, under the Federal Food, Drug, and Cosmetic Act and related
regulations. Most other advertising, including the advertising of
over-the-counter drugs, is regulated by the Federal Trade Commission,
under a different set of rules.

FDA generally interprets the term "advertisement" to cover information
other than labeling that promotes a product. The term includes
promotions broadcast on television or radio, conducted by telephone,
or printed in magazines or newspapers. (Also see [3]"Drug Promotion in
Cyberspace.")

For many years, prescription drug makers promoted their products
exclusively to health-care professionals. But about 15 years ago, some
manufacturers began to produce ads targeted to consumers.

Graph showing Direct-to-Consumer Advertising of Prescription
Medications 1993-1996

Since then, direct-to-consumer advertising has become a popular
promotional tool. In 1996 alone, prescription drug manufacturers spent
almost $600 million on this type of advertising, according to
Competitive Media Reporting, which projects 1997 spending to be at
least twice that.

And consumer-directed ads seem to be capturing consumers' attention.
In a 1996 study by drug industry consultant Scott-Levin,
three-quarters of the doctors surveyed said their patients have talked
about drug ads they heard or saw.

FDA regulates consumer-directed ads under the same regulations as
professional-directed ones. Like promotions directed to health-care
providers, consumer ads may only make claims that are supported by
scientific evidence and that are not inconsistent with the
FDA-approved product labeling. And, like professional-directed
advertisements, they may not be false or misleading.

FDA oversight helps ensure that consumers understand both the benefits
and limitations of an advertised drug. (See [4]"In Trouble with FDA.")
The agency monitors ads to make sure they are tailored for the target
audience. For example, a consumer-directed ad may be considered
misleading unless it explains the drug's benefits and risks in words
that people who aren't medical professionals can understand.

FDA regulations call for "fair balance" in every ad. FDA reviewers
look at the entire advertisement to see if it is balanced. The risks
as well as the benefits must be clearly identified, with the risks
presented prominently and readably so that the benefits are not
unfairly emphasized.

Under the Federal Food, Drug, and Cosmetic Act, most ads must include
a "brief summary" describing the effectiveness of the drug and its
risks. In print ads, drug companies usually meet the requirement by
including entire risk-related sections of the approved labeling. Many
people have expressed concern to FDA that, because drug labeling is
primarily written for doctors, much of it cannot be understood by
consumers.

"The brief summary might be fine for someone who went through medical
school," says Linda Golodner, president of the National Consumers
League. Even then, she says, "you have to get out a magnifying glass
to try and sort out the information."

FDA is considering what steps can be taken toward a more
consumer-friendly format. In the meantime, says Ostrove, "We encourage
manufacturers to write the brief summary information to be more
understandable to consumers."

_TV Reality_

In a short television or radio ad, manufacturers have found it
difficult to meet the brief summary requirement. "Scrolling a long,
detailed brief summary on a television screen is not practical on
commercial television," writes drug law expert Wayne Pines in the
Thompson Publishing Group's Advertising and Promotion Manual.

So, for television commercials and sometimes print ads, companies have
historically opted for two types of ads--"reminder" ads and
"help-seeking" ads--that are exempt from the brief summary
requirement.

Reminder ads, like the original version of the Claritin commercial,
call attention to a drug's name, but don't state the condition it is
used to treat.

Help-seeking ads tell consumers only that there are treatments
available for a particular condition and encourage them to talk to a
health-care professional. To be considered a help-seeking
advertisement, an ad may not state or imply the name of a particular
product, although it can mention the manufacturer's name. One such
magazine ad said simply, "Life without ulcers. It is now possible. See
your doctor."

The reminder and help-seeking ad "each has only part of the
information a consumer wants, which can create a lot of confusion,"
Ostrove says.

_Completing the Puzzle_

FDA regulations have always permitted sponsors of television and radio
ads to present a brief summary. Or, instead, they could make "adequate
provision" for interested people to get the approved labeling.

Before August 1997, FDA had not described "adequate provision" for
consumer-directed ads, so drug companies were not taking advantage of
the option because they were uncertain about whether their ads would
meet FDA's standards.

The draft guidance doesn't change the regulation, but rather describes
one way to meet the requirement. Under the approach described in the
guidance, "adequate provision" is accomplished if the ad contains the
following:
* a toll-free telephone number so consumers can request the approved
package labeling by mail, fax, or prerecorded telephone message
* a reference to print ads about the product in consumer magazines
so consumers can read more detailed drug information, or to
brochures containing the package labeling that a consumer can find
conveniently in public places such as libraries, pharmacies,
doctors' offices, and grocery stores
* a statement that additional product information is available from
a doctor or pharmacist
* an Internet address where package labeling can be found.

Whether the brief summary or "adequate provision" is used, however,
the most important risk information must always be included in the ad
itself. This information is often referred to as the "major
statement."

_Joint Responsibility_

Some consumer-directed ads can raise awareness that drugs are
available to treat certain conditions, including diseases such as
seasonal allergies that might not require a doctor's care, and
undertreated conditions such as depression and impotence. "We have a
huge patient population for which there are drugs available to help
them live longer and better lives," says John Kamp of the American
Association of Advertising Agencies. He adds that government agencies
and medical professionals "can use their tools until they're blue in
the face and not reach the people who will be reached through
television."

While a doctor's prescription is necessary to get these medications,
some at the 1995 public hearing expressed a concern that this
alternative source of drug information would interfere with the
doctor-patient relationship. The National Consumers League's Golodner
and others, however, feel that consumers will communicate with their
physicians more, not less, if they are aware that a drug exists for
their condition.

"In health care," Golodner says, "there is a general trend toward
having consumers more responsible for their own health. Now, consumers
can go to their physicians with a little more information."

A related issue raised at the 1995 public hearing is whether such ads
would lead to patients pressuring doctors to prescribe unneeded
medications. Many speakers emphasized the doctors' duty to advise
their patients responsibly. Mary Jane Sheffet, from Michigan State
University's marketing department, told FDA, "The doctor needs to be
there as a gatekeeper."

With the health concerns of both supporters and opponents in mind, the
agency continues to review its policies on direct-to-consumer
promotion. FDA will finalize the draft guidance on consumer-directed
broadcast advertising, the first step of the review, after considering
all comments received during the 60-day comment period, which ended
last Oct. 14.

As more ads have been reviewed by FDA, Ostrove says, the agency "has
become more and more confident that the appropriate information,
including risk information, can reach consumers and be helpful to
them."

But the foremost goal of advertisers will always remain the same: to
get people to use their products. So Ostrove urges consumers to regard
prescription drug ads with thoughtfulness.

"These are prescription drugs with real potential downsides," she
says. "We don't want people going to their doctor and saying, 'I want
this drug.' The message should be, 'I saw this ad. Is it right for
me?'"

Tamar Nordenberg is a staff writer for FDA Consumer.

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In Trouble with FDA

Generally, FDA does not require pre-clearance of promotional
materials. But the agency often reviews drug companies' draft
promotional materials at their request.

If FDA finds that an advertisement a company is using is false or
misleading, the agency may take enforcement action against the
company. The agency regulates all of a drug company's prescription
drug promotions, including the promotional tactics of its salespeople.

For the least serious violations of advertising regulations, FDA will
send the drug company an "untitled letter" outlining FDA's findings.

For more serious violations, FDA may issue a "warning letter"
requesting that the company immediately stop the violative advertising
and, in many cases, take other corrective steps.

For example, the company may be asked to send a "Dear Doctor" letter
to alert those who prescribe the medication to FDA's finding. The
company may also be asked to run corrective advertisements setting
forth FDA's concerns and bringing the ad's language into compliance.
Finally, a warning letter may request that a company send its future
promotional materials to FDA for clearance before they are used.

Beyond sending untitled letters and warning letters, FDA may stop
violative promotions by seizing affected products or enjoining the use
of promotions that make the same or similar claims. These actions and
the most serious remedy, criminal prosecution of the company or the
individuals involved, are used rarely--generally when intentional and
serious misstatements are involved.

The threat of agency action isn't the only thing that keeps companies
honest, says John Kamp of the American Association of Advertising
Agencies. "A drug company won't play fast and loose with the rules
because its most important asset is its reputation with the American
people."

--T.N.

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Drug Promotion in Cyberspace

Like many other companies, prescription drug marketers are beginning
to take advantage of the extensive reach of the Internet to promote
their products. FDA monitors the Internet to check the quality of the
information provided, and encourages consumers to remain vigilant to
separate the good information from the bad. (See [5]"Health
Information On-Line" in the June 1996 FDA Consumer.)

"Generally, FDA is treating Internet promotion like it does other
forms of promotion," says Melissa Moncavage, a public health advisor
with FDA's division of drug marketing, advertising, and
communications. "Although the Internet is brand new, the promotion
content issues are largely the same as print, broadcast, and other
traditional media."

To address those issues that are unique to the Internet, FDA held a
public meeting in October 1996 to hear from consumers, patient groups,
health professionals, manufacturers of FDA-regulated products, and
others.

The questions discussed at the meeting included:
* Where should promotional product information be located on a
company's Website?
* How can promotional information on the Internet be clearly
distinguished from other information?
* How can Internet users be ensured access to a balanced
presentation of risks and benefits?
* Should Websites distinguish between Internet promotions directed
to health professionals and consumers? How?
* How should the promotional materials of multinational companies be
addressed to ensure compliance with U.S. drug laws and
regulations?

Also, in a Sept. 16, 1996, Federal Register notice, FDA requested
written comments on some of these same Internet-related drug promotion
issues. The agency is considering the written comments, suggestions of
meeting participants, and information received since the meeting, and
plans to publish a draft guidance to clarify its policies.

--T.N.

FDA Consumer magazine (January-February 1998)
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References

1. http://www.fda.gov/fdahomepage.html
2. http://www.fda.gov/fdac/198_toc.html
3. http://www.fda.gov/fdac/features/1998/ly3879.html#cyberspace
4. http://www.fda.gov/fdac/features/1998/ly3879.html#trouble
5. http://www.fda.gov/fdac/features/596_info.html
6. http://www.fda.gov/fdahomepage.html
7. http://www.fda.gov/fdac/198_toc.html