Protecting Consumers,
Promoting Public Health

Slide 1

U. S. Food and Drug Administration: 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,
  • To monitor products for continued safety after they are in use, and
  • To help the public get the accurate, science-based information needed to improve health.

Slide 2

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 by the relative risks that the products pose to consumers.

Slide 3

Benefits vs. Risks

• At the heart of all FDA's regulatory activities is a judgment about whether a new product's benefits to users will outweigh its risks.
• Science-based, efficient risk management allows the agency to provide the most health promotion and protection at the least cost to the public.
• 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--

Slide 4

Safe, Wholesome, 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.

Slide 5

Safe and Effective

• 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

• Medicines used for the treatment and prevention of disease,

Biologics

• 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 new medical devices are reviewed by the agency before marketing.

Slide 6

Safe 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.

Slide 7

Safe 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.

Slide 8

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.

Slide 9

Truthful 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.

Slide 10

What does it cost?

• All of this is a bargain for America's taxpayers.

Less than 2¢ a Day

• When you divide FDA's budget by the number of people we protect, it costs just over a penny a day per person.

Slide 11

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.

Slide 12

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.

Slide 13

New Hazards, New Laws

• In 1937, a public health disaster tragically drove home the need for a stronger federal law. Sulfanilamide, the first "wonder drug" and a popular and effective treatment for diseases like strep throat and gonorrhea, was formulated into an Elixir of Sulfanilamide and marketed for use in children. But the liquid formulation 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.

Slide 14

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.

Slide 15

FDA In Your Neighborhood

• To carry out its mission, FDA employs some 9,000 people who work in locations around the country.
• The network of 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.

Slide 16

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:

Slide 17

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 premarket review for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs.

Slide 18

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.
• We make more than 16,000 visits a year 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.

Slide 19

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.

Slide 20

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.

Slide 21

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.

Slide 22

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 the threat of terrorism, 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.

Slide 23

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.

Slide 24

FDA Priorities

• FDA's priorities focus on building the capacity to make sound, responsive regulatory decisions and improving the safety of products that have the greatest public health impact. The agency will:

Risk Management

Target our resources for enforcement, product approval, and monitoring domestic manufacturing and imports at the areas that present the greatest public health risks

Better Consumer Information

Make sure people have the accurate, science-based information they need to make smarter health decisions

Postmarketing Safety

Greatly enhance our ability to identify and correct risks from medical products that emerge after they are marketed

Counterterrorism

Strengthen our capability to identify, prepare for, and respond to terrorist threats

Effective Regulation/Strong Workforce

Recruit and train a world-class professional workforce, build efficiency in operations, and have the resources needed to accomplish our mission.

Slide 25

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:

Slide 26

www.fda.gov

• FDA's Web site 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.

Slide 27

Read All About It

• The FDA’s consumer publications are a great source of health 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.
• Our other publications include reprints from FDA Consumer magazine, easy-to-read brochures, FDA fact sheets, and public service announcements.
• To get any of these publications, visit the FDA Web site, contact your local FDA office, or call our toll-free numbers.

Slide 28

Call Us…

• Here are our toll-free numbers, one for all FDA topics, and the other for food and food safety.
• Contact your local FDA office by looking in the phone book's blue government pages under U.S. Government/Food and Drug Administration.

Slide 29

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.

Slide 30

Consumer protection, health promotion

• 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!

An FDA Overview: Protecting Consumers, Protecting Public
Health produced by FDA Office of Public Affairs, August 2004