July 30, 2002

Dockets Management Branch

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

RE: Docket No. 02N-0209

> Comment on Direct to Consumer Advertising of Pharmaceuticals
>
> Public Health Impact

To Whom It May Concern:

Please accept these comments, on behalf of Community Catalyst, Health
Care For All and Health Law Advocates, on direct-to-consumer
pharmaceutical advertising (DTCA). Community Catalyst is the convener of
the Prescription Access Litigation Project (PAL). PAL is a coalition of
84 organizations from 34 states and the District of Columbia whose
mission is to reduce the price paid by American consumers for
prescription drugs by creating a consumer voice on the key issue of
pharmaceutical pricing practices. Health Care For All and its law firm,
Health Law Advocates, are Massachusetts-based nonprofit organizations
dedicated to making affordable and quality health care available to
everyone, regardless of income or social status.

As advocates of improved access to health care, including affordable,
therapeutic prescription drugs, we are concerned about the impact of
DTCA on consumer behavior, prescribing trends and drug costs. We
strongly believe that the FDA's regulation of DTCA[^1] is more than
justified by the potential public health impact of DTCA, and is
consistent with First Amendment free speech law.[^2] DTCA was approved
in order to expand consumer knowledge of pharmaceuticals, thereby
allowing consumers informed participation and choice in their own health
care. In order for DTCA to serve this purpose, it is essential that the
FDA vigorously impose and maintain standards regarding the type and
extent of information that is included in any DTCA. Without these
requirements, DTCA will fail to serve the limited and important purpose
for which it was first allowed.

I.  **[Introduction]{.underline}**

While pharmaceuticals offer the hope of health improvements to many
Americans, substantial costs and risks accompany any potential benefits
of consuming prescription drugs. Aided in part by direct-to-consumer
advertising, our nationwide prescription drug market continues to grow
at a phenomenal rate,[^3] burdening an increasing number of consumers
with the astronomical costs of brand-name drugs as well as the potential
health risks posed by consumer-driven prescribing patterns.[^4] Although
the full extent of DTCA's health effects is a matter of ongoing
research,[^5] preventive regulation of this powerful industry marketing
tool is necessary and prudent to protect the public's health.

These comments support the public health need for the regulation of
DTCA, and propose ways in which we believe the FDA's regulations in this
area should be strengthened to better protect consumers. First, DTCA
influences risk perception, consumer behavior and physician prescribing
patterns. Second, adverse drug events (ADEs) due to inappropriate
prescribing are a known and dangerous health risk. Third, the
pharmaceutical market in the United States has reached unprecedented
proportions, and DTCA contributes to rising pharmaceutical consumption.
In every sense of the phrase, this is truly a "public health" issue
requiring FDA regulation, as vast numbers of Americans shoulder the
potential risks, costs, and benefits involved. While the pharmaceutical
industry reaps huge profits as a result of its expanded marketing
capacity, it should not also enjoy completely unregulated advertising
freedom where the public's health may be put at risk. Finally, these
comments conclude with recommendations for improved regulation of DTCA.

# **The Evidentiary Basis for Protecting the Public's Health By Regulating DTCA** 

###  DTCA Fosters Misperception of Pharmaceutical Risks

Direct-to-consumer advertisements, in both broadcast and print media,
manipulate individuals' perceptions of marketed drugs through sleek
appeals to emotion. Even while in full compliance with current FDA
marketing guidelines, consumer-oriented advertisements "play up the
positive features of a drug and down-play the negative or unknown
aspects. Side effects... are almost always discussed last \[and\] are
buried in the narrative."[^6] This imbalance in risk perception serves
the manufacturers' interests, not the consumers'. "When consumers are at
least partially aware of health and safety risks, manufacturers have
incentives to manipulate risk perceptions in the manner that benefits
them most."[^7]

Television commercials prove particularly effective in manipulating risk
perception. In the dilution of risks by positive aural and visual
messages, televised pharmaceutical advertisements "lull" consumers into
a state of reduced vigilance regarding self-protection from risk.[^8]
Evidence shows that viewers of televised prescription drug commercials
gain awareness of the benefits of specific drugs and fail to understand
all of the potential side effects,[^9] resulting in documented
"miscomprehension" of drug ads.[^10] By using all of the seductive
marketing techniques available in this most absorbing, pervasive medium,
pharmaceutical manufacturers convince consumers of the benefits of their
products while failing to communicate the risks.

Print advertisements also use techniques to downplay risk perception and
bolster benefit perception and emotional response. For example,
pharmaceutical manufacturers commonly purchase both the front and back
of one magazine page for an advertisement. This allows them to display
the eye-catching, wholly positive and emotion-oriented message on the
front of one page while hiding the "brief summary" of risks and
contraindications on the back, often in unreadable and unappealing type.
Deciphering the "brief summary" requires a professional-level reading
proficiency and a grasp of biostatistics, such that these advertisements
fail to communicate risk or efficacy information to most consumers.
Considering that the vulnerable elderly, in particular, make up a large
percentage of prescription drug consumers, the opaqueness of this risk
information may prevent any meaningful communication. Pharmaceutical
companies use both broadcast and print media to present stylish
advertisements that appeal to deep fear, anxiety, and hope, while
obscuring or down-playing risk information, in order to influence
patient's perceptions of how the advertised drugs may improve their
lives.

Our national experience with product advertisement and public health,
particularly the lessons learned from the tobacco industry's mass
marketing campaigns, provides a cautionary tale against allowing the
manufacturers of potentially harmful products to enjoy unregulated
marketing freedom. While we do not equate potentially beneficial
pharmaceutical advertising to the intentionally misleading tobacco
campaigns, comparing the two industries illustrates how manufacturers
influence consumer behavior with well-crafted product promotion. For
example, through the presentation of glossy, seductive advertisements
meant to target very specific public concerns, tobacco manufacturers
succeeded in lowering consumer risk perceptions.[^11] The tobacco
industry effectively responded to trends in consumer culture, for
example, by promoting "low-tar" cigarettes as a "healthier" alternative
when public awareness of smoking risks began to increase.[^12] Even more
troubling, tobacco advertisements "succeeded in creating demand...by
conveying to smokers a sense of independence, autonomy, and
sexuality."[^13] Instead of focusing on the cigarette products
themselves, many advertisements promoted wonderful feelings associated
with consuming the products.[^14]

Similarly, pharmaceutical advertisements promote prescription drugs
through highly stylized campaigns that appeal to emotion. Consider the
Viagra advertisement showcasing an attractive middle-aged man zooming
around a race track behind the wheel of a sports car, or the
advertisement for Rogaine hair loss treatment, where a good-looking
female "state\[s\] unequivocally, 'I know that a man who can afford
Rogaine is a man who can afford me.'"[^15] These ads, echoing the
manipulative techniques used in the tobacco product campaigns, also
influence consumer perceptions and behavior by insidiously playing to
emotion.

### DTCA Influences Physician Prescribing Patterns

Advertising-induced patient demand may adversely influence physicians'
prescribing patterns. In fact, physicians cite patient demand as the
most common reason for inappropriate prescribing.[^16] The influence of
DTCA may substantially increase the potential for ill-considered,
patient-driven prescribing decisions, particularly within managed care
systems where physicians face limitations on the amount of time they can
spend with each patient. Furthermore, in a health care culture
increasingly dominated by notions of patient autonomy and collaborative
patient-physician relationship models, patient demand plays a crucial
role in determining the course of treatment. Although objective
information about therapeutic options and possible side effects may
empower patients and lead to informed conversations with providers,
direct-to-consumer advertising does not necessarily effect such a
balanced approach.

## [Adverse Drug Events Pose Serious Risk to Consumers]{.underline}

Nationwide growth in pharmaceutical consumption threatens "sizable and
increasing numbers of people" with adverse drug events from medication
errors.[^17] One compelling analysis of "62,216 visits to an emergency
department... found that 1,074 (1.7 percent) were related to medication
noncompliance or inappropriate prescribing."[^18] Evidence also shows
that the number of medication-related deaths between 1983 and 1993
increased at a faster rate for outpatients (8.48-fold) than for
inpatients (2.57-fold), reflecting our new national appetite for
pharmaceuticals.[^19] Furthermore, outpatient adverse drug events are
estimated to account for between 2.4 and 11 percent of hospital
admissions, a majority of which are preventable, as well as an
increasing number of visits to physician offices and emergency
departments.[^20] Prescription drugs, while offering therapeutic
benefit, also cause serious harm. In light of this potentially serious
harm, it is critical that DTCA be as accurate and informative as
possible.

## [The Pharmaceutical Market in the United States Affects a Sizeable and Growing Number of Consumers]{.underline}

The current prescription drug market in the United States surpasses all
previous proportions.[^21] As a country, we consume more[^22] and pay
more for[^23] our pharmaceuticals than ever. For example, between 1993
and 1998, the number of prescriptions filled increased from 1.9 to 2.5
billion.[^24] Within the same interval, "the number of antidepressant
prescriptions filled increased by 111 percent, and that for
cholesterol-lowering drugs rose by 162 percent. For oral antihistamines,
the increase was fully 500 percent."[^25] Furthermore, the categories
with the greatest increases are also those most commonly advertised. The
bill for this increased consumption hits consumers hard. Patient
spending on prescription drugs jumped more than 17 percent in 2001, to
\$175.2 billion.[^26]

The increasing demand and rising profits in the pharmaceutical industry
result in part from aggressive direct-to-consumer advertising.[^27]
Between 1996 and 2000 alone, the industry increased spending on DTCA by
212 percent, and by a factor of 7 for televised DTCA in particular.[^28]
Manufacturers target the consumer through broadcast media with good
reason. The pervasiveness of television exposure in the average American
home provides a powerful marketing opportunity. By some measures, the
average American household watches over four hours of television per
day.[^29] Approximately 76 percent of American homes have 2 or more
televisions, and the television is on for 7 hours, 40 minutes per day on
average in each home.[^30]

In the face of this powerful marketing opportunity, and with some state
governments pushing legislation to curb direct-to-*provider* marketing
techniques,[^31] DTCA is likely to become an even more prominent method
of pharmaceutical promotion in the near future. Although drug
manufacturers still spend most of their advertising dollars promoting
drugs to providers,[^32] DTCA continues to grow disproportionately,[^33]
evincing the growing interest of manufacturers in promoting drugs
directly to patients. Furthermore, evidence demonstrates that DTCA is
just as effective, if not more, than direct-to-provider
advertising.[^34] The possibility of shifting an increasing proportion
of promotional dollars to DTCA, while experiencing the same huge
profits, would allow the pharmaceutical industry to market in a realm
that may be less vulnerable to legislative reform.[^35]

One would hope that the growing magnitude of the pharmaceutical market
only bodes well for the health of the public. However, to assume as much
and allow the proliferation of unregulated DTCA would put Americans at
risk. Given the prevalence and severity of adverse drug events from
inappropriate prescribing, the behavioral effects of DTCA, and the
ability of consumers to influence physician prescribing patterns, there
is considerable public health justification for continuing to require
the balanced presentation of risk information in pharmaceutical
advertisements. The FDA must continue to uphold its mandate to protect
the public's health[^36] by regulating the content of DTCA.

II. [Recommendations for Strengthening the FDA's Regulation of DTCA to
    Protect the Public Health]{.underline}

Many aspects of the FDA's current regulation of DTCA[^37] serve the
interests of public health, particularly the required inclusion of risk
information in advertisements that explicitly promote drug benefits. It
is imperative, in light of the public health risks involved in
advertising potentially dangerous pharmaceutical products, to maintain
at least this baseline level of consumer protection. Three key areas in
the FDA regulations require adjustments that would serve the public
health but not unduly infringe on the pharmaceutical industry's right to
advertise freely.

1.  [FDA Regulations Should Require Clear, Balanced Risk Information In
    All DTCA]{.underline}

Consumers deserve clear, complete risk information in all pharmaceutical
advertisements. Currently, drug commercials put the onus on the consumer
to seek out a balanced understanding of a drug's risks and benefits,
which does nothing to protect the public from the important (and usually
only) impression of a drug made by its advertisement. Our suggested
modifications to the FDA regulations would prevent DTCA from
communicating imbalanced risk/benefit messages. First, for broadcast
advertisements, because most individuals watch television or listen to
the radio in a relatively passive state, the FDA should temper the
distracting positive auditory and visual messages that embroider risk
messages in DTCA. For example, the FDA should require manufacturers to
*present risk information in louder, clearer, more audible voice-overs.*
For print advertisements, manufacturers should have to *print risk
information in highlighted text boxes on the main promotional
advertisement,* not relegated to the unreadable "brief summary" on the
opposite side of the page.

In addition, we urge the FDA to require *the inclusion of understandable
efficacy information* in DTCA. This information is meaningful and
important in making treatment decisions, and if DTCA is serving the
educational purpose for which it was initially approved, presentation of
efficacy information is indispensable. The efficacy data in most "brief
summaries" are far too technical to communicate anything meaningful to
consumers. Instead, we recommend that the FDA require manufacturers to
distill results from drug trials in a one- to two-line, easily
understood efficacy statement, which must be included in all DTCA "major
risk statements." This would help ensure that DTCA serves an
educational, awareness-raising purpose, as originally intended, instead
of allowing it to mislead consumers for the financial benefit of
pharmaceutical manufacturers.

2.  [FDA Regulations Should Eliminate the "Reminder Advertisement"
    Exception to Required Inclusion of Risk Information]{.underline}

One way to combat inappropriate prescribing would be to limit the
ability of manufacturers to cultivate brand-name popularity through
"reminder advertisements" without disclosing product risks. For this
type of DTCA, the FDA currently waives its risk disclosure requirements
if the manufacturer refrains from describing the drug's benefits or
indications.[^38] This *waiver of risk inclusion requirements should be
eliminated.* Allowing prescription drug suppliers to induce consumer
demand and reinforce irrational preferences for certain brands may have
negative public health implications, including both rising drug
expenditures and increased incidence of adverse drug events.

Furthermore, "reminder advertisements" fail to serve any identifiable
educational purpose. They allow the manufacturer of a drug to enjoy an
exemption from describing its risks, while still using the mass media to
imply benefits and reinforce a glamorous brand-name image for the
product. "Reminder advertisements" foster "'irrational' consumer
preferences"[^39] in the hopes of developing patient brand loyalty. This
marketing technique may help account for the fact that in 2001 the 50
drugs with the largest price increases were brand-name options, and they
showed disproportionately high increases in sales: 34 percent compared
to an average of 9 percent.[^40]

3.  [The FDA Should Continue to Prohibit Advertisement of Off-Label
    Uses]{.underline}

*Allowing the advertisement of off-label drug uses would subvert the FDA
drug approval process and put the public health at risk.* Permitting
off-label DTCA would reinforce an incentive for manufacturers to submit
drugs to the FDA only for those indications that are easiest to approve
for sale (where, for example, efficacy is easy to prove), and then
promote more lucrative, unapproved uses to physicians and consumers.
Because physicians may legally prescribe drugs for unapproved uses,
off-label drug sales are only limited by the manufacturer's capacity to
convince physicians and consumers of the off-label benefits. Off-label
DTCA would drastically expand this marketing capacity and effectively
replace the FDA's drug approval process with promotional campaigns. The
FDA would be sanctioning the use of unapproved drugs and putting
consumers at risk. We are opposed to allowing DTCA of off-label
prescription drug products because of the considerable risks to
consumers.

III. [Conclusion]{.underline}

The FDA must continue to regulate the advertisement of pharmaceuticals
to protect the public from the dangers of consumer-driven prescribing
patterns and adverse drug events. *DTCA regulations should require all
advertisements to include some mention of risks and efficacy data, and
this information should be presented in a clear, easy-to-understand
format.* These small measures may help offset the documented confusion
and misperceptions that result from the bombardment of positive messages
inherent in current DTCA. While FDA's regulations should respect the
pharmaceutical industry's right to advertise its products, the burdens
of effective risk communication in DTCA are minimal, and pale in
comparison to the potential public health burden imposed by unregulated
DTCA.

Thank you for your consideration. If you have any questions please
contact Clare McGorrian at Health Law Advocates.

Sincerely,

Ahaviah D. Glaser

Prescription Access Litigation Project Director

Community Catalyst

Michael Miller, Policy Director

Health Care For All

Clare D. McGorrian, Senior Staff Attorney

Emilia VandenBroek, Legal Intern

Health Law Advocates

Cc: The Massachusetts Congressional Delegation

[^1]: 21 C.F.R. §202.1, as authorized by 21 U.S.C. §352(n), and the
    Kefauver-Harris Amendment of 1962, PL 87-781, 76 STAT. 780 codified
    in section 21 U.S.C. §502(n).

[^2]: The Supreme Court recently held that the FDA's ban on the
    promotion of compounded drugs by providers violated the First
    Amendment because it amounted to an undue restriction on free
    speech. *Thompson v. Western States Medical Center,* 122 S.Ct. 1497
    (2002). However, nothing in *Thompson* justifies the elimination of
    FDA regulation of DTCA. *Thompson* concerns a ban on *all* promotion
    of compounded drugs, including truthful information. In contrast,
    the DTCA regulations do not prevent the dissemination of truthful
    promotional information on approved pharmaceuticals, and only
    require the inclusion of risk information in the advertisements to
    help protect consumers. DTCA regulations are minimal and reasonable
    in comparison to those at issue in *Thompson*.

[^3]: Schweitzer, Stuart O. and Comanor, William S. "Chapter Five:
    Pharmaceutical Prices and Expenditures." [Changing the U.S. Health
    Care System: Key Issues in Health Services Policy and
    Management]{.underline}. Ed. Ronald M. Andersen, Thomas H. Rice, and
    Gerald F. Kominski. San Francisco: Jossey-Bass, Inc., 2001.

[^4]: [To Err Is Human: Building a Safer Health System]{.underline}. Ed.
    Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson. Institute
    of Medicine. Washington: National Academy Press, 2000. p. 33.

[^5]: Lyles, Alan. "Direct Marketing of Pharmaceuticals to Consumers."
    [Annual Review of Public Health]{.underline}. 23 (2002): 73-91.

[^6]: Wilkes, Michael S., et al. "Direct-to-Consumer Prescription Drug
    Advertising: Trends, Impact, and Implications." [Health
    Affairs]{.underline}, 19 (2000): 110-128, 116.

[^7]: Hanson, Jon D., and Kysar, Douglas A. "Taking Behavioralism
    Seriously: Some Evidence of Market Manipulation." 112 Harv. Law
    Review 1420, 1466. (1999).

[^8]: See footnote 7, p.1456.

[^9]: "Understanding the Effects of Direct-to-Consumer Prescription Drug
    Advertising." The Henry J. Kaiser Family Foundation. (Nov. 2001).

[^10]: See footnote 9, generally.

[^11]: See footnote 7, p. 1469.

[^12]: See footnote 7, p. 1473

[^13]: See footnote 7, p. 1471

[^14]: See footnote 7, p. 1471.

[^15]: See footnote 7, p. 1471.

[^16]: Schwartz, RK, Soumerai, SB, and Avorn, J. "Physician Motivations
    for Nonscientific Drug Prescribing." [Social Science and
    Medicine]{.underline} 28 (1989): 577-582.

[^17]: See footnote 4.

[^18]: See footnote 17, p. 35

[^19]: See footnote 17, p. 32-33

[^20]: See footnote 17, p. 35

[^21]: See footnote 3.

[^22]: See footnote 3.

[^23]: Freudenheim, Milt. "Drug Spending Rises Sharply at Pharmacies and
    by Mail." [New York Times]{.underline} 29 Apr. 2002, Washington
    ed.:. A18.

[^24]: See footnote 23.

[^25]: See footnote 3.

[^26]: See footnote 23. The \$175.2 billion total includes \$154.5
    billion spent on prescriptions filled in pharmacies as well as
    \$20.7 billion spent on mail-order prescription filling services.

[^27]: See footnote 23. See also: Waxman, Judith, Deputy Executive
    Director of Families, USA. Testimony before the U.S. House of
    Representitives Committee on Government Reform Subcommittee on
    National Security, Veterans Affairs and International Relations.
    Boston, Mass., 22 July 2002., and Rosenthal, Meredith B., et al.
    "Promotion of Prescription Drugs to Consumers." [The New England
    Journal of Medicine]{.underline}. 346 (2002): 498-505.

[^28]: See footnote 6, p. 116.

[^29]: "Facts and Figures about our TV Habit." TV Turnoff Network, at
    [http://www.tvfa.org/images/facts&figs/factsheets/Facts%20and%20Figures.pdf](http://www.tvfa.org/images/facts&figs/factsheets/Facts and Figures.pdf),
    accessed 4.28.02. Citing: Neilsen Media Research 2000.

[^30]: See footnote 29.

[^31]: For example, on June 13, Vermont Gov. Howard Dean signed a bill
    to "require pharmaceutical company representatives to publicly
    disclose all gifts valued at or above \$25, excluding drug samples,
    given to doctors, hospitals, and nursing homes." Proponents hope the
    bill will discourage providers from prescribing more expensive
    brand-name drugs due to the influence of physician-oriented
    advertisements. "Vermont Governor Signs Bill Requiring Reporting of
    Gifts to Doctors by Drug Companies." Kaisernetwork.org Daily Health
    Policy Report, Prescription Drugs, 14 June 2002. Retrieved from:
    http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=3&DR_ID=11739.

[^32]: Rosenthal, Meredith B., et al. "Promotion of Prescription Drugs
    to Consumers." [The New England Journal of Medicine]{.underline}.
    346 (2002): 498-505.

[^33]: See footnote 32.

[^34]: See footnote 32.

[^35]: See footnote 31.

[^36]: The 1938 Food, Drug and Cosmetic Act gave the U.S. Food and Drug
    Administration its mission, which includes promotion of the public
    health through "appropriate action on the marketing of regulated
    products," and protection of the public health in "ensuring
    that...human and veterinary drugs are safe and effective." 21 U.S.C.
    §393 (b).

[^37]: See footnote 1.

[^38]: 21 CFR 202.1(e)(2)(i)

[^39]: McCarthy, S. "McCarthy on Trademarks and Unfair Competition." S
    2:38, 4^th^ ed.

[^40]: See footnote 23.