Improving Healthcare through Better Information

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.

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).

• 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, hypertension^17,18 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).

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