An Overview of FDA: Protecting Consumers, Promoting Public Health
The Food and Drug Administration is one of the nation's oldest and most respected consumer protection agencies. This presentation will tell you about FDA's responsibilities, the tools we use to fulfill those responsibilities, and our priorities for improving the way we serve the public.
Stated most simply, FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use.
What Have We Done For You Lately
Our purpose today is to put a human face on the Food and Drug Administration.
First, here are a few examples of our accomplishments and how they may have affected you and your family.
Medical Breakthroughs
FDA has streamlined its review process in recent years to help speed important new medical treatments to patients. For example, the average review time for an innovative new drug is now only 6 months, and some have been approved even faster.
Products receiving accelerated reviews include new treatments for breast cancer; a rapid, reliable diagnostic test for pneumonia; and devices to improve the monitoring and treatment of diabetes.
Safer Foods
The last several years have seen an increase in the number and severity of food-borne illnesses around the country. FDA has launched a major initiative to prevent the spread of these food-related infections. The initiative promotes safer food-handling practices by producers and consumers, and more effective detection, tracking and prevention of food-borne illness.
Safer Blood Supply
A similar initiative aims at improving the safety practices in the blood banking and plasma industries.
FDA works to continuously improve donor screening, blood testing, and other quality control procedures in blood donation and blood banking. The agency helps the industry develop and use new, more accurate tests to detect hazards in the nation's blood supply.
Broad Responsibilities
Every day, every American comes in contact with a host of FDA-regulated products.
Varied products
. . . Everything from the most common food ingredients to complex medical and surgical devices, lifesaving drugs, and radiation-emitting consumer and medical products.
$ 1 trillion a year
In fact, FDA-regulated products account for about 25 cents of every consumer dollar spent.
Varied approaches
FDA's regulatory approaches are as varied as the products it regulates.
Some products -- such as new drugs and complex medical devices -- must be proven safe and effective before companies can put them on the market.
Other products -- such as x-ray machines and microwave ovens -- must measure up to performance standards.
And some products -- such as cosmetics and dietary supplements -- can be marketed with no prior approval.
These differences are dictated by the laws we enforce and the relative risks that the products pose to consumers.
Benefits vs Risk
At the heart of all FDA's product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks.
No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great -- especially for products used to treat serious, life-threatening conditions.
Next, let's look a the product areas we regulate--
Safe, Whole and Sanitary Foods
FDA safeguards the nation's food supply by making sure that all ingredients used in foods are safe, and that food is free of contaminants -- like disease-causing organisms, chemicals, or other harmful substances.
The agency must approve new food additives before they can be used in foods.
FDA also monitors the safety of dietary supplements and the content of infant formulas and medical foods.
Meat and poultry products, however, are regulated by the USDA.
Safe and Effective Medicines, Biologics, Medical Devices
Medical products need to be proven safe and effective before they can be used by patients. The product categories covered by this requirement include:
Medicines used for the treatment and prevention of disease,
Biologics -- a product category that includes vaccines, blood products, biotechnology products and gene therapy -- and
Medical Devices: FDA regulates all medical devices, from very simple items like tongue depressors or thermometers to very complex technologies such as heart pacemakers and dialysis machines. However, only the most complex medical devices are reviewed by the agency before marketing.
Safer Consumer and Medical Radiation Products
FDA also protects the public from unnecessary exposure to radiation from electronic products. These include microwave ovens, cell phones, x-ray equipment, lasers, medical ultrasound and MRI machines, and many other consumer, industrial, and medical products.
Our responsibilities in this area include special monitoring of mammography facilities to be sure that their equipment is safe and they are properly run.
Save and Effective Animal Drugs
FDA regulates drugs and devices used for animals, both pets and animals that produce food. Before manufacturers can market animal drugs (including drugs used in animal feeds), they must gain FDA approval by providing proof of their safety and effectiveness.
Veterinary medical devices do not have to be pre-approved by FDA before marketing, but they still must be safe, effective, and properly labeled.
Livestock drugs are evaluated for their safety to the environment and to the people who eat the animal products. FDA makes sure that any drug residues that remain in these foods aren’t harmful to the consumers who eat them.
Safe Cosmetics
FDA monitors cosmetic products to be sure that they are safe and properly labeled. But these products and their ingredients are not reviewed or approved by FDA before they are sold to the public, and FDA cannot require safety testing.
Truth and Informative Labels
Consumers rely on product labels to know what the product is and how to use it. FDA regulates what's on these labels to ensure that they are truthful and that they provide useable information that helps consumers make healthy, safe decisions when using the product.
In recent years we have redesigned the labeling for foods, over-the-counter medicines and dietary supplements, making them much more informative and easy to read.
We also oversee the labeling for drugs and medical devices used by health professionals to ensure that the products have the information needed for proper use.
What Does It Cost?
All of this is a bargain for America's taxpayers.
When you pide FDA's budget by the number of people we protect, it costs just over a penny a day per person.
Who We Are
Most of FDA's budget goes toward paying its highly skilled and internationally respected work force. Our employees are drawn from a wealth of science and public health professions -- including biologists, chemists, physicians, biomedical engineers, pharmacologists, veterinarians, toxicologists, and specialists in public health education and communication.
Since 1906...
We've come a long way from the time when the safety of food additives was determined by feeding them to a "Poison Squad" of federal employees.
Congress laid the foundation for modern food and drug law when it passed the Food and Drugs Act of 1906. This first nationwide consumer protection law made it illegal to distribute misbranded or adulterated foods, drinks and drugs across state lines.
New Hazards New Laws
In 1937, a public health disaster tragically drove home the need for a stronger federal law. A new antibiotic preparation, Elixir of Sulfanilamide, was formulated and marketed for use in children. But the drug contained a poison, the same chemical used in antifreeze, and it killed 107 people, most of them children. The earlier law did not require the drug's manufacturer to test the formulation for safety before it was sold.
Congress corrected this weakness in the law the next year when it passed the Federal Food, Drug, and Cosmetic Act. This law, for the first time, required companies to prove the safety of new drugs before putting them on the market. The new act also added the regulation of cosmetics and therapeutic devices, and generally updated the law to improve consumer protection.
Congress has continued to give FDA new responsibilities over the years, including the requirement that drugs and medical devices be proven effective as well as safe before they can be sold.
Science, Regulation, Consumer Protection
FDA's role today has evolved to respond to the challenges of regulating complex and sophisticated industries. Our work is a blending of law and science aimed at protecting consumers.
FDA in the Neighborhood
To carry out its mission, FDA employs some 9,000 staff who work in locations around the country.
The network of 167 field offices is generally the first point of contact for the public and regulated manufacturers. The employees in these offices focus on inspection and surveillance, laboratory work, and public and industry education.
The FDA staff who work in the greater Washington, D.C., area focus on product review and regulatory policy.
How We Do Our Job
FDA's work can be described as five types of jobs or activities. Here is a brief look at what FDA does:
New Product Review
FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself.
We do this pre-market review for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs.
Keeping Watch
Once products are on the market, FDA keeps track of how they are manufactured and responds to reports of problems or newly identified risks.
Safe manufacturing and handling.
To ensure the safety of marketed products, FDA staff inspect domestic and foreign manufacturers, check shipments of imported products, and collect and test product samples for signs of contamination.
Last year we made more than 16,000 visits to facilities that handle FDA-regulated products. We also have cooperative arrangements with many state governments to help increase the number of facilities that are checked.
Monitor for new risks
Because initial testing of products is based on a relatively small number of users, and because variations in quality can happen in manufacturing, FDA keeps careful watch on reports of adverse experiences with products after they are marketed. The agency receives more than 400,000 problem reports a year.
If this monitoring turns up a problem that needs to be corrected, FDA can ask the manufacturer to recall the product, withdraw approval (of a drug, for example), require labeling changes, or send warnings to physicians or other health practitioners.
Standards and Regulations
FDA uses regulations and product standards as the "yardsticks" that define specific requirements manufacturers must follow to assure product safety and to provide accurate information to health professionals and consumers.
FDA works with foreign governments to encourage the safety and quality of imported products by making sure that foreign standards are equivalent to those enforced by FDA.
Research
FDA's research activities provide the scientific basis for its regulatory decisions and the tools needed to identify and assess risks.
The agency uses its research results to guide standard setting, evaluate new products, develop test methods and other support for product monitoring, and to study emerging risks.
Enforcement-Correcting Problems
When a problem arises, FDA can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily.
If that fails, legal remedies include asking the manufacturer to recall a product, having federal marshals seize products if a voluntary recall is not done, and detaining imports at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law.
Our Challenges
Today, more than ever, FDA needs to respond to a rapidly changing world. There are many obstacles to overcome if we are to continue our high standards of consumer protection. The most important of these challenges are:
Scientific breakthroughs
FDA scientists will need to keep up with rapidly-advancing technologies in all product areas.
More sophisticated products
These technologies will translate into products with new complexities and risks.
New public health threats
We'll need to be prepared to respond rapidly to unexpected health risks, such as tougher strains of antibiotic-resistant bacteria or more dangerous foodborne illnesses.
International commerce
Monitoring of imports and cooperation with foreign regulators will become more important as international commerce continues to grow.
Consumer information
Finally, today's sophisticated consumers and the wide availability of information about FDA-regulated products will challenge us to be sure consumers are getting the information they need from the right sources.
Working With Partners to Meet the Challenge
As we respond to these challenges and future challenges, we will be changing our ways of doing business while maintaining our high standards for consumer protection.
We will work more collaboratively with our partners in government, industry, health professions, and educational institutions. We are also asking these partners and the general public what they think about how FDA can do a better job.
Priorities for the Year 2000 and Beyond
FDA's priorities -- as we begin the new century -- focus on building the capacity to make sound, responsive regulatory decisions, and improving the safety of products that have the greatest public health impact.
Strong Science
FDA will need to strengthen its scientific capabilities to keep up with the technology of the products and industries it regulates.
Expanded scientific knowledge and better research must provide the foundation for our regulatory decisions, and they will help us better understand health risks and respond to them more quickly.
Product Safety
The ultimate goal, of course, is to improve the safety of all products used by U.S. consumers.
Want to Know More
If this quick overview of FDA and how it does business has piqued your curiosity, there are several ways you can learn more:
FDA's Website
FDA's Website is the entry point to a wealth of information about all of our programs and product areas.
You can find information for consumers, health professionals, industry, and the latest news on FDA-regulated products.
Call Us
Here are our toll-free numbers, one for all FDA topics, call 1-888-INFO-FDA (1-888-463-6332), and the other for food and food safety, call 1-888-SAFEFOOD (1-888-723-3366).
Contact your local FDA office by looking in the phone book's blue government pages under U.S. Government/Food and Drug Administration.
Get It In Writing
FDA's consumer publications are a great source of information about new products and other topics of interest.
FDA Consumer is a bimonthly magazine that provides in-depth coverage of the latest FDA topics, plus reports of FDA regulatory and enforcement activities. We also distribute backgrounders on current topics, easy-to-read brochures, posters, films, and slide shows like this one.
To get any of these publications, contact your local FDA office, call the toll-free numbers or visit the FDA Website.
Your Views Are Important
FDA's primary "customer" is the public, and we want to know what you think about our existing and proposed policies.You can tell us what you think in a number of ways, including:
Commenting on new and revised FDA regulations through the Federal Register and our electronic dockets on the Web,
Attending public meetings,
Serving on an FDA advisory committee, as a scientific expert -- or consumer, health professional or industry representative, and,
Using our problem reporting systems to let us know when you have a concern about a product.
FDA's public affairs specialists, located in our offices around the country, are your first resource and can give you guidance about the best way to take advantage of these opportunities.
Protecting Consumers, Promoting Public Health-The End
We hope that this presentation has given you a clearer picture of the Food and Drug Administration's mission and how we protect consumers and promote the public health.
Please take advantage of the information available from the agency about all of the topics we've touched on today. And be in touch -- we want to hear from you! Thank you!
