# Presentation: 481464

## Integration Activities

**June 5,  2002**

- ACE-ITDS-DHHS/FDA
**Trade Support Network Meeting **

## Slide 2

**Notes:**
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. 

## Varied Products

**Varied Products**

**$1 Trillion A Year**

**Varied Approaches**

**Notes:**
Every day, every American comes in contact with a host of FDA-regulated products.

Varied products (adds text line)
.  . . 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 (adds text line)
In fact, FDA-regulated products account for about 25 cents of every consumer dollar spent.

Varied approaches (adds text line)
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.

## Slide 4

**Notes:**
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.

## Medicines

**Medicines**

**Biologics**

**Medical Devices**

**Notes:**
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 (Adds text to slide)

Medicines used for the treatment and prevention of disease,

Biologics (Adds text to slide)

Biologics -- a product category that includes vaccines, blood products, biotechnology products and gene therapy -- and

Medical Devices (Adds text to slide)

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.

## Slide 6

**Notes:**
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

**Notes:**
FDA also approves drugs and devices used for animals, including pets and animals that produce foods. 

Livestock drugs are evaluated for their safety to the environment and to the people who eat the animal products.  FDA assures the safety of drug residues that remain in these foods when consumers eat them.

## Slide 8

**Notes:**
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

**Notes:**
FDA regulates what's on product 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.

Medical products, like other consumer products, need labels so consumers know what the product is and how to use it.  

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

**Notes:**
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.

## Slide 11

**Notes:**
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--

## Slide 12

**Notes:**
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’s Office of Regulatory Affairs

- _FDA’s Office of Regulatory Affairs_

**Notes:**
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.

(Speaker may want to compare the size of FDA's work force with that of a familiar local corporation or other organization)

## Slide 14

**Notes:**
FDA's work can be described as five types of jobs or activities.  Here is a brief look at what FDA does:

## Scientific

**Scientific**
**Breakthroughs**

**More Sophisticated**
**Products**

**New Public Health**
**Threats**

**International**
**Commerce**

**Consumer**
**Information**

**Notes:**
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 (Adds text to slide)
FDA scientists will need to keep up with rapidly-advancing technologies in all product areas.

More sophisticated products (Adds text to slide)
These technologies will translate into products with new complexities and risks.

New public health threats (Adds text to slide)
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 (Adds text to slide)
Monitoring of imports and cooperation with foreign regulators will become more important as international commerce continues to grow.

Consumer information (Adds text to slide)
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 16

**Notes:**
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.

## Initial Focus on Food Safety

## Product Safety:

_***Understanding the Lifecycle of the Imported Product!***_
- Product Ingredients & Sources
- Product Manufacture
- Product Handling/Shipping/Chain of Custody
- Product Adverse Event Reports
- Product Manufacturer “History”

**Notes:**
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.

## Product Safety (Continued):
Refresh Standard Data Set Element Requirements - Critical Data Review
Prepare FDA/CFSAN integration requirements for ACE - Concept of Operations 
Establish Supporting Data Mapping and Data Flows, as Appropriate
Assess Innovations to Risk Assessment & Management
Finalize High- Level Requirements 

- Refresh Standard Data Set Element Requirements - Critical Data Review
- Prepare FDA/CFSAN integration requirements for ACE - Concept of Operations
- Establish Supporting Data Mapping and Data Flows, as Appropriate
- Assess Innovations to Risk Assessment & Management
- Finalize High- Level Requirements

## Product Safety (Continued):
Assess and establish a more effective “Product
Code/Commodity ID System”
“Upgrade” FDA’s Operational and Administrative System for Import Support”
“Link” FDA’s Internal Databases
Utilize advances in Information Technology to facilitate Risk Assessment/Management and Decision Making

- Assess and establish a more effective “Product
- Code/Commodity ID System”
- “Upgrade” FDA’s Operational and Administrative System for Import Support”
- “Link” FDA’s Internal Databases
- Utilize advances in Information Technology to facilitate Risk Assessment/Management and Decision Making

## "Wishful thinking might bring comfort, but not security."

**-PRESIDENT BUSH****  **

**Notes:**
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.

## Product Security:

_*Product Security:*_
_***Mitigation of risks to prevent FDA products from becoming vectors of terrorism.***_
- Testing for Rapid Detection of Adulteration
- Permissive Debarment
- Registration of Facilities, I.e., Manufacturers, Packers, Processors, Holders
- Maintenance and Inspection Records

**Notes:**
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.

## Product Security (Continued):

- Prior Notice
- Marking articles refused entry
- Prohibitions against “Port Shopping”

## Features of ACE that can be leveraged in FDA:

Enhanced Data (By synchronizing the Manifest with entry declaration)
Additional Data (Use opportunity to include data requirements that are legally mandated in trade filings)
Leverage lifecycle/account management concepts
Leverage Portal infrastructure to set up FDA inspector in-boxes
Leverage Rules-based selectivity engine to maintain dynamic screening criteria
Establish Port actions based on screening results
Leverage ACE communication channels with trade to improve FDA communication to trade. example; send an electronic message to trade (importer /broker and shipper) if a hold on a shipment is released after examination.

- Enhanced Data (By synchronizing the Manifest with entry declaration)
- Additional Data (Use opportunity to include data requirements that are legally mandated in trade filings)
- Leverage lifecycle/account management concepts
- Leverage Portal infrastructure to set up FDA inspector in-boxes
- Leverage Rules-based selectivity engine to maintain dynamic screening criteria
- Establish Port actions based on screening results
- Leverage ACE communication channels with trade to improve FDA communication to trade. example; send an electronic message to trade (importer /broker and shipper) if a hold on a shipment is released after examination.

- Leveraging of ACE

## Backup Slides

_***Backup Slides***_

## Slide 26

**Notes:**
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.

## Safe Manufacturing

**Safe Manufacturing**
**And Handling**

**Monitor For**
**New Risks**

**Notes:**
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 (Adds text to slide)

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 (Adds text to slide)

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 28

**Notes:**
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 29

**Notes:**
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 30

**Notes:**
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.