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Protecting and Advancing Consumer Health and Safety

Executive Summary

Consumer health and safety form the core of FDA’s mission to protect and advance the public health, which is more important today than ever. Upon taking office in November 2002, FDA Commissioner Mark McClellan highlighted various key challenges facing American consumers and patients – such as the growing epidemics of obesity and diabetes, the dangers posed by counterfeit drugs, the persistent harm caused by medical errors, and new and sophisticated forms of terrorism.

In response to these public health threats, the Agency has developed a core set of consumer-focused goals – including better consumer information, improved patient and consumer safety, more effective counterterrorism, and a stronger, science-based FDA. These goals were developed and refined in conjunction with a number of key healthcare stakeholders, and were based on important feedback from the consumer and patient communities. Furthermore, they were designed to build upon key initiatives underway through the Department of Health and Human Services (HHS) and the Bush Administration.

Over the past year, FDA has taken many actions to address these consumer goals, from bioterrorism preparedness to better information on nutrition and disease to increased access to safe, affordable drugs. The following is a brief summary of some of these steps to protect and advance the public health:

  1. Bolstering consumer safety through significant industry regulations and risk communications
  2. Protecting Americans from new forms of terrorism and emerging diseases
  3. Cracking down on false products and false promises
  4. Reducing preventable medical errors
  5. Speeding access to safe and affordable medicines
  6. Helping consumers improve their health through better information and greater "health literacy"

I. Bolstering consumer safety through significant industry regulations and risk communications

Over the past year, FDA has issued comprehensive regulations that bring all new levels of consumer protection and patient safety to Americans. These significant regulatory actions, along with various communications and guidances to industry and consumers, have improved the safety and security of all of FDA’s regulated products. Following are some of the most notable consumer safety regulations and actions taken over the past year.

Strengthening food safety and security
In 2003, building on an HHS strategic goal, FDA implemented new food security regulations that amount to the most substantial expansion of FDA’s food safety activities in three decades. The Agency has also undertaken various new risk communications to improve upon more routine food safety for consumers.

Most comprehensive regulation ever of potentially unsafe dietary supplements
In 2003, the Agency issued groundbreaking regulations against unsafe dietary supplements.

Protecting Americans from unsafe drugs and biologics
FDA introduced important new regulations to improve medical safety, as well.

Promoting more balanced, informative advertising and claims
In addition to enhancing the safety of FDA-regulated products, the Agency has worked to improve the information and claims surrounding these products through better risk communications.

II. Protecting Americans from new forms of terrorism and emerging diseases

In the wake of September 11th, Americans face new, sophisticated threats of terrorism, including risks posed by the possible contamination of the nation’s food supply. Consumers are also confronted with deadly emerging diseases like SARS and the West Nile Virus. In direct response to these heightened threats, over the past year FDA has implemented a number of fundamental enhancements to the Agency’s food and medical safety activities.

Countering bioterrorism
Countering bioterrorism has been a major priority for the Department of Health and Human Services and, in particular, Secretary Thompson. In the event of a bioterrorist attack on America’s food supply, the consequences for public health and safety could be catastrophic. In direct response to this heightened threat, and in conjunction with HHS’s larger counterterrorism initiatives, FDA has implemented new steps in food security that represent the most fundamental enhancements in the Agency’s food safety activities in many years.

Combating emerging diseases
In addition to sophisticated terrorist threats, Americans face increasing risks from various emerging diseases – most notably, SARS, the West Nile Virus, and bovine spongiform encephalopathy (BSE or "mad cow disease"). Over the past year, FDA has taken several important steps to fight these and other deadly diseases and improve consumer safety nationwide, and worldwide.

Speeding the development of safe countermeasures to improve protection against terrorism and emerging diseases
Protecting consumers against terrorism and emerging disease also requires that Americans have access to safe and effective medical countermeasures. This year, FDA has worked closely with scientists and product developers and has taken new steps to speed the development of these safe, effective treatments.

III. Cracking down on false products and false promises

While significant new regulations and collaborative initiatives have helped protect Americans and shape the public health roadmap for the future, the Agency has also made major strides in cracking down on past and present violations of the nation’s health through active enforcement. Over the past 12 months, FDA has taken a number of significant enforcement actions to ensure consumer safety. The Agency’s enforcement strategy has focused on the most efficient way to get the most compliance with the law and the greatest safety benefits for consumers; the Agency has used the full range of its enforcement tools to get the most "bang for the buck" in terms of protecting the public health. In 2003, FDA made particular headway in addressing two serious, growing threats – counterfeit and unsafe drugs and false claims.

Strengthening enforcement actions where they matter most
FDA’s most decisive enforcement actions remain those that remove violative products from the market and that bring criminal charges against people whose actions violate FDA laws and regulations and threaten the public health. These efforts have increased the most over the past year.

(All above numbers are for FY2003)

Preventing counterfeit and other unsafe drugs
The volume of counterfeit and other unsafe drugs has risen sharply in recent years, and technologies for distributing tainted, dangerous drugs over the Internet have become more sophisticated. Everything from table punch tools to advanced dyes is more widely available to criminals. The result is that, more than ever before, well-organized criminals stand ready to exploit any crack in the country’s regulatory system to profit at the expense of the public health. In response, FDA has taken new actions to help safeguard the drug supply from fake and adulterated medicines.

Countering false claims
The last few decades have witnessed a major increase in the amount of labeling claims and direct advertising to consumers regarding new products that purport to improve their health. This has many benefits for consumers, as there are more scientific insights and more products than ever that can help consumers enhance their health. However, ads and labeling claims can also be misleading or deceiving, and FDA has focused its enforcement efforts over the past year to ensure consumers are not being harmed as a result of claims that overstate the effectiveness of a product or suggest treatment for a broader range of conditions than a drug was approved for.

IV. Reducing preventable medical errors

Every year, Americans suffer thousands of deaths, millions of hospitalizations, and tens of billions in added health care costs all stemming from avoidable medical errors. According to recent estimates, between 1% and 3% of hospital admissions are attributable to medication errors, and the direct cost of preventable drug-related mortality and morbidity may be as high as $77 billion annually (excluding cost of pain and suffering).

Preventing adverse medical events is a top priority at the Department of Health and Human Services and at FDA, and over the past year, FDA has introduced a number of solutions that are enabling a more sophisticated and effective 21st century patient safety system, thus helping lower healthcare costs and ensure longer, healthier lives for Americans. As a result of these new strategic initiatives, more programs are now in place to improve consumer safety than at any time in the Agency’s history.

Modernizing regulations and improving surveillance to improve health and save lives
FDA is taking steps to automate and integrate critical medical data so that the Agency can get the right information at the right time in the hands of doctors, patients, pharmacists, and other key healthcare partners. In particular, over the past year FDA has placed a major emphasis on electronic medical records and other information technology.

Individualizing medicine through pharmacogenomics
Pharmacogenomics deals with the small genetic differences that help define why people respond differently to the same medication. FDA believes better analysis of pharmacogenomic data can close current information gaps regarding why different people derive different benefits and experience different side effects from new drugs.

Proposing new safety standards
FDA is introducing several new medical standards to further reduce the incidence of adverse events.

V. Speeding access to safe and affordable medicines

Today, there is more spending on biomedical R&D; than ever before, and there are more new drugs and devices in development than ever before, and yet there are fewer new medical products reaching consumers than at any time in more than a decade. It’s getting harder and more uncertain than ever to develop new treatments. At the same time, Americans are also facing unprecedented challenges involving affordability and access to the treatments that do make it onto the market, especially prescription drugs. Many Americans cannot afford the necessary treatments for their health ailments, and are unable to realize the full benefit of the products that are available. Too often, consumers are forced to make difficult choices between safe and affordable treatments.

The challenge is to ensure access to safe and affordable medical products and to get critical treatments in the hands of Americans who need them. With this in mind, FDA has taken a number of unprecedented actions over the past year, designed to get more affordable and innovative medical treatments to Americans, wherever possible, without compromising safety.

Saving consumers billions by increasing access to generic drugs
When approved by the FDA, generic drugs are just as safe and effective as brand-name drugs, but they often cost 70 percent less. Since 2002, FDA has launched several major initiatives to improve patient access to generic drugs. These steps are expected to save consumers well over $3 billion per year. Improved consumer education and generic drug science could also lead to billions in additional savings from greater consumer confidence and wider use of generic drugs. Specifically, FDA’s generic drug initiatives include:

Getting treatments to patients faster by speeding innovation
In January 2003 FDA launched a broad new agency-wide initiative to help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products while maintaining FDA’s traditional high standards of consumer protection. FDA is committed to reducing total review time for new drugs and biologics across the board by approximately 10.5% through this initiative. Such reductions in review time for drugs and biologics, as well as for new devices, will place much needed treatments in the hands of patients faster, thus helping to prevent deaths, avoid other adverse events, and improve overall health. Specifically, the innovation initiative includes:

VI. Helping consumers improve their health through better information and greater "health literacy"

A well-informed public is one of the best weapons against some of the biggest public health threats facing the country. Simply put, better information means that consumers can make better health choices.

Better information for better nutrition
One key area where consumers need better information is nutrition. Today, almost two-thirds of all Americans are overweight, and according to some estimates, at least 300,000 deaths each year and tens of billions of dollars in health care costs are associated with heart disease, diabetes, cancer, and other serious chronic diseases that result in part from unhealthy nutritional choices and lack of physical activity. Secretary Thompson has made obesity and nutrition a top priority for all of HHS. In line with this effort, FDA has focused on getting the latest and safest science-based information to consumers, helping them to make smarter decisions about the foods they eat.

Better information for safer medical usage
The need for better consumer information also extends to the medical products FDA approves. Better information about the risks, benefits and costs of drugs and other treatments is critical to ensuring safer medical usage, as well as to helping consumers get more for their money – particularly with generic drugs.

Conclusion

The FDA Strategic Plan unveiled in 2003 set ambitious goals for protecting and advancing consumer health and safety. Thanks to strong efforts from all of FDA’s professional staff, sound science, and effective risk management, the Agency made tremendous progress toward these public health goals in 2003.

Over the past 12 months, FDA has issued a vast number of new regulations and notices aimed at protecting and promoting the health and safety of consumers – and Agency enforcement remains very active. These efforts are defending Americans against increasingly sophisticated health threats, and are opening up all new opportunities for health innovation and improvement.

In 2004, FDA will continue to build on its strategic initiatives and will work aggressively to protect and advance the public health. Specifically, FDA will continue its rigorous regulatory activities, and will look to further define a strategic planning process for enforcement that will include: identifying and targeting violations that have the greatest public health significance; identifying the best enforcement tools to maximize the Agency’s enforcement impact; focusing inspection resources in those areas where the Agency finds violations with the greatest public health significance, and focusing resources based on the element of risk associated with the violations encountered. FDA will also build on its efforts to educate citizens to recognize fraud when they see it and warn them of the potential dangers of these products when they arise.

In fighting terrorism and emerging diseases, the Agency will maintain and extend key collaborations with sister agencies, foreign governments and industry partners, as necessary, in order to protect the public as efficiently and effectively as possible. Furthermore, FDA will continue to roll out its comprehensive food security regulations to stem the possible threat of bioterrorism.

To further reduce adverse medical events, FDA will continue to support the development and implementation of electronic medical records and other safety standards and innovative technologies that reduce risks for patients.

Over the coming year, FDA expects to take further steps to improve its review processes for generic drugs, and to issue further regulations under its new authorities from Congress to remove litigation barriers to generic competition. Additionally, FDA will continue to explore ways to make the overall development process as clear, as fast, and as cost-effective as possible. The Agency will look to further define the “critical path” for therapeutic development – i.e. the most efficient and effective pathway leading from initial concept and discovery through research and development and eventually through market approval and beyond.

Finally, in 2004, the Agency will look to further improve the flow of key health information to American consumers. Whether by building on nationwide education campaigns, or finalizing guidances on health claims, nutrition and other important health topics, FDA will do whatever it can to help consumers get better science-based information on how they can improve their health

In all of these ways, the FDA will continue to uphold its public health mission and will help all Americans live longer, healthier, and happier lives.

Press Release

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