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Improving Healthcare through Better Information is one of
five initiatives established for FDA to address five critical
challenges facing the agency.
Through this initiative, FDA will provide information to consumers,
health professionals, and other constituencies that will enable
them to make prudent decisions regarding the use of FDA-regulated
products. A well-informed constituency will raise the likelihood
that product risks will be reduced and improved health outcomes
will be realized.
Enable consumers to make smarter decisions
by getting them better information to weigh the benefits
and risks of FDA-regulated products. |
For all that the FDA can accomplish through efforts to improve
enforcement and regulatory protections for the public--as well
as to help encourage the development of safer, more effective,
and affordable food and medical technologies--people, through
their own choices, can have an even greater impact on improving
their health. For example, in 2000, total costs of obesity were
calculated to be $117 billion ($61 billion direct and $56 billion
indirect). As the prevalence of obesity continues to rise, the
long-term health and economic consequences of obesity will be
astounding. Lack of physical activity and poor nutrition account
for approximately 300,000 deaths each year, making these risk
factors second only to tobacco use in causes of preventable
death.11
It has been estimated that up to 48 percent of
English-speaking patients in the United States lack functional
health literacy--the ability of an individual to understand,
access, and use health-related information and services.12
U.S. Surgeon General Richard H. Carmona recently recognized
low health literacy as a widespread problem affecting public
health preparedness, addressing health care disparities, and
disease prevention.13
Combined with the increasing incidence of many
health problems, such as diabetes and obesity, this is a serious
public health problem. Clearly, making sure that health information
available to consumers is clear, informative, and effective
in helping them to improve their health is more important than
ever. And the importance of protecting consumers from misleading
information is greater than ever as well.
From encouraging better guidance to patients in pharmacy labels,
to giving clearer guidance on communicating risk and benefit
information in direct-to-consumer advertising, to launching
new enforcement initiatives against dietary supplement manufacturers
who make health claims without scientific foundation, the FDA
is undertaking major new efforts to help consumers make better-informed
decisions about how to use their health care dollars.
All non-prescription, over-the-counter (OTC) drug labels
must have detailed use and warning information for consumers.
The FDA accomplishes this important task in a number of ways.
First, the FDA takes steps to ensure that information provided
by a product's sponsors is accurate and that it communicates
information consumers need to know in order to safely use a
product. Second, the FDA itself communicates directly with the
public and through health care providers concerning risks and
benefits of regulated products.
The scope of this communications responsibility is especially
significant when it comes to food, as the FDA regulates some
75 percent of all foods consumed here, and given the current
national epidemic of obesity and the related consequences, such
as heart disease and diabetes.
The FDA knows that consumers want the best information available
about each of the products they use. And consumer research has
demonstrated that more and better information helps consumers
make smarter and better-informed decisions. A recent study by
the Federal Trade Commission on peoples' interpretation of food
nutrition and health claims in advertising found that people
are able to accurately interpret these kinds of qualified claims,
even in cases where there are limitations in scientific support,
so long as the specific disclosures are clear and accurate.
Recent innovations, such as the new label on over-the-counter
(OTC) drugs (Figure 2) and direct-to-consumer (DTC) advertising,
have had positive effects on consumer health decision-making.
For example, consumer research conducted in developing the OTC
drug label showed that the new label would increase consumers'
confidence in their ability to use the information on the label
and better enable them to make correct product-use decisions.
Yet the FDA also knows that information can at times be confusing
to some consumers, and too much information can provide a cacophony
of data that can obscure the most important facts. Obviously,
scientific accuracy is a key element of effective communication
for consumers. Some other factors that affect the value of written
medical information include, for example, the vocabulary and
grammar used, the size of the typeface, and patient-related
factors having to do with the patient's literacy.14
Consider the situation with the nutrition information on food
products. Since 1993 consumers have been able to use the Nutrition
Facts panel on food packages to help decide what foods to purchase.
These labels were developed with the intent of enhancing the
ability of Americans to make healthy diet choices. However,
data on the health of Americans, particularly the growing problem
of obesity, suggest that we are making dietary and other lifestyle
choices that adversely affect our health despite access to this
information (see below).
Obesity
and Nutrition-Related Illness in the United States |
- The World Health Organization
considers obesity one of the top five health problems in the
developed world, including the United States.15
- Almost 65 percent of U.S. adults
were overweight (BMI = 25) in 1999–2000.16
- Obesity is associated with type
2 diabetes, cardiovascular disease, hypertension17,18
and some cancers.
- There was a 10-fold increase
in incidence of type 2 diabetes among children between 1982
and 1994.19
- Obesity is estimated to account
for 5.5 to 7.8 percent of all health care expenditures.20
The FDA's strategic plan calls for the agency to improve its
knowledge about effective communications to consumers and health
care providers throughout all of its major activities, including
drugs, medical devices, and food products. The agency's current
and future communication strategies for conveying risk, as well
as the promotional activities of FDA sponsors, will be scientifically
evaluated for their effectiveness in reaching target audiences
and conveying information that is accurate and not misleading.
The agency will be seeking out communications experts in academia,
other government agencies, and industry to assist in these efforts.
Other key strategies include:
- Taking steps to improve the FDA's
processes for reviewing industry communications to consumers
and health care providers
- Enhancing the FDA's processes
for reviewing message content and delivery
- Ensuring that critical health
messages are being delivered in ways that meet the health
needs of targeted groups, including the underserved and at-risk.
Empowering Consumers: FDA's Objectives
Objective 1 – Develop an FDA-wide consumer communications
infrastructure.
Action Item Highlight: Provide new important information
on pediatric labeling to advocacy groups and health care providers.
About 75 percent of all drugs prescribed for children are not
tested for use in children,21 and
as a result they may be ineffective or even harmful. The 2002
Best Pharmaceuticals for Children Act (BPCA) was intended to
encourage the study of drug therapies in children. The BPCA
also required public dissemination of important news about pediatric
drug information and labeling changes.
Objective 2 – Enhance the FDA's efforts to help ensure
that industry communications to consumers and health care providers
are truthful and not misleading, provide information about product
risks and benefits, and appropriately convey the degree of scientific
uncertainty associated with such product messages.
A well-informed public is one of the best weapons against some
of the biggest public health threats facing the country. Better
information means that consumers can make better choices. And
some of the most important health choices that people make are
about the foods they choose to eat. Our choices about our diets
are choices about our health. Those choices should be based
on the best and latest scientific information. One of the FDA's
most important public health tasks is to help ensure that Americans
can rely on that information to make smart decisions about food.
To make these smart decisions, people need good, clear information
about the nutritional value of their foods. They also need to
be protected from misleading information, from "snake oil"
claims that create false hopes and can get in the way of improving
their health.
The Task Force on Consumer Health Information for Better Nutrition
was charged, among other things, with developing a system for
the FDA to help consumers get more accurate information about
the health consequences of their food choices. The FDA believes
that this process for making science-based health claims, when
combined with the agency's strong enforcement work, will help
people choose healthier products. More effective enforcement
of the law against companies that make false or misleading health
claims also means that consumers can rely on the science-based
information on the label.
The health claims that the FDA believes are highest priority
to go through this enhanced FDA-regulated process are the ones
where the evidence seems quite good already--not definitively
settled, but good enough that many expert organizations believe
people should know about it in making their diet choices. The
claims that the agency intends to review for possible inclusion
on food labels in the months ahead include:
- Consuming 5 to 9 servings of
fruits and vegetables a day may reduce your risk of cancer
and other chronic illnesses
- Substituting foods that are high
in unsaturated fats for foods high in saturated or trans fats
(vegetable oils instead of solid fats) may reduce your risk
of heart disease
- A diet that features foods high
in omega-3 fatty acids, or that substitutes tree nuts instead
of proteins high in saturated fats, may reduce your risk of
heart disease
In order to create an environment for good information, the
agency is committed to aggressively pursuing those who make
false and misleading claims. In 2002, the FDA inspected more
than 80 dietary supplement firms, several of which voluntarily
corrected identified violations. In February 2003, the FDA seized
dietary supplements from a firm in Florida in light of illegal
claims that the products would treat a variety of medical conditions,
including prevention of cancer and treatment of arthritis. More
recently, the FDA worked with the FTC in May 2003 to crack down
on Internet marketers of products claimed to protect against,
treat, and even cure Severe Acute Respiratory Syndrome (SARS).
Direct-to-Consumer (DTC) advertising has become an important
source of patient information about prescription drugs. Research
demonstrates that these ads can have a positive impact on patient/physician
communications. For such advertising to best inform consumers,
it must effectively communicate not just the potential benefits
of the advertised prescription drug, but also potential risks,
such as those associated with drug interactions and the specific
health condition of the individual considering taking the drug
(see box).
Direct-to-Consumer Advertising
The pharmaceutical industry estimates that in 2001 it spent
$2.7 billion on direct-to-consumer (DTC) ads. In 1999 and
2002, the FDA conducted surveys looking at the impact of
DTC ads on the doctor-patient relationship. Considerable
research suggests that DTC advertising helps people who
have untreated conditions get the treatment they need and
encourages consumers to get more involved in understanding
their health problems, both of which improve health outcomes:
- 81 percent of consumers
had seen a DTC ad in the previous 3 months, and of those
consumers who asked their doctors about a particular
brand-name drug, 88 percent had the condition the drug
treats.
- About 30 percent of the
patients and half the doctors said that the advertising
helped them have better patient-doctor discussions about
the patient's health.
- About 40 percent of the
patients and 45 percent of the doctors felt that the
ads encouraged information-seeking about potentially
serious medical conditions.
On the downside, many doctors and others believe that DTC
ads may not be giving patients an accurate picture of the
risks and benefits of the treatments involved:
- 75 percent of the doctors
felt that ads made it seem like the drugs would work
for everyone or that patients believed the drug to be
more efficacious than it actually is.
- Half the doctors felt that
the ads created unnecessary anxieties about health,
and more than half felt that they were at least a little
pressured to prescribe the specific medication.
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Highlights for Objective 2
- Develop draft guidance on a scientific
evidence-based rating system for qualified health claims for
conventional foods and supplements.
- Expand efforts, in conjunction
with the Federal Trade Commission (FTC), to take action against
unsubstantiated claims on dietary supplements through warning
letters, seizures, and/or injunctions against misbranded products.
- Develop guidance for industry
on the content of the "brief summary" for direct-to-consumer
advertising.
Objective 3 – Improve and increase FDA-initiated health
benefit-risk information
- Action Item Highlight: Implement joint campaign with
the CDC to educate the public and health care providers about
antimicrobial resistance.
Addressing the growing problem of resistance of antibiotics
used to treat human illnesses, the FDA recently issued a final
rule requiring that labeling for all systemic antibacterial
drugs intended for human use include statements that the improper
use of antibiotics will lead to drug-resistant bacterial strains.
The rule encourages physicians to prescribe antibiotics only
when clinically necessary, and to take the time to counsel their
patients on the proper use of these drugs.
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Footnotes
11CDC, Unrealized Prevention Opportunities
2000.
12Andrus MR, Roth MT. Health literacy:
a review. Pharmacotherapy. 2002 Mar; 22(3): 282-302.
13Carmona, RH. Remarks before the
American Medical Association House of Delegates meeting. June
14, 2003.
14Koo MM, Krass I, Aslani P. Factors
influencing consumer use of written drug information. 37 Annals
of Pharmacotherapy: 259-267 (2003).
15Hill JO, Wyatt HR, Reed GW, Peters
JC. Obesity and the environment: where do we go from here? Science
299" 853-855 Feb. 7 2003.
16Flegal KM, Carroll MD, Ogden CL,
Johnson CL. JAMA 2002 Oct 9; 288(14): 1723-7.
17Flegal KM, Carroll MD, Ogden CL,
Johnson CL. JAMA 2002 Oct 9; 288(14): 1728-32.
18Okosun, IS, Chandra, KMD, Choi
S, Christman, J, Dever, GEA, Prewitt TE. Hypertension and type
2 diabetes comorbidity in adults in the United States: risk
of overall and regional adiposity. 9 Obesity Res. 1: 1-9 (2001).
19Hill JO, Wyatt HR, Reed
GW, Peters JC. Obesity and the environment: where do we go from
here? Science 299" 853-855 Feb. 7 2003.
20Hill JO, Wyatt HR, Reed
GW, Peters JC. Obesity and the environment: where do we go from
here? Science 299" 853-855 Feb. 7 2003.
21Doran T. Testimony on
behalf of the American Academy of Pediatrics before the Federal
Trade Commission on Health Care and Competition Law and Policy.
Feb. 27, 2003. Accessed at http://www.aap.org/advocacy/washing/doran%5F2%5F27%5Ftestimony.htm(June
23, 2003).
Complete FDA Strategic
Plan
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