NPR: FDA's High Impact Agency Goals Status Report

Summary Status Report on FDA Reinvention Goals, August 2000

The Food and Drug Administration, designated by the National Partnership for Reinventing Government as a High Impact Agency, presents this semi-annual progress report on its four "reinvention" goals. The status of each goal is summarized below.

Select the name of each goal to obtain more information.

Goal Full Goal Statement Progress Highlights

More Efficient Drug Development By the year 2000, reinvent the drug development and review process, thereby lowering the development costs and, more importantly, reducing by an average of one year the time required to bring important new drugs to the American public. FDA will accomplish this through early and frequent consultation with product sponsors, implementation of an automated application filing process and an electronic document management system, and reauthorization of an enhanced user fee program.
The Industry Meeting Tracking system (IMTS) is fully operational with review divisions entering meetings into the system. PDUFA meetings guidance to industry was issued in March and the comment period ended in May. Comments are currently being reviewed.

Guidance on full electronic NDAs (for archive) was published. Agency is now ready to receive and review NDAs electronically. Previously, only case report forms and tabulations were being received and reviewed electronically.

Guidance on submitting regulatory data for ANDAs in electronic form was published this fiscal year. Guidance on electronic ANDAs (for archive) will be published in FY 2001.

The electronic document management system is operational. An enhanced version is under development and will be released later this year.

Better Medical Product Information According to legislative mandate, 75 percent of all consumers receiving new drug prescriptions will be given more useful and readable information about their product by the year 2000. Usefulness is defined in terms of scientific accuracy, unbiased content and tone, specificity and comprehensiveness, and timeliness. Based on national surveys conducted by FDA, the percentage of people who received useful information on new drug prescriptions was only 32 percent in 1992. To achieve the 75 percent goal, FDA will work closely with industry, health care providers and the consumer. Simultaneously, FDA will revise prescription drug and OTC labels to make them more readable. These information and labeling initiatives will improve the accurate use of medications and reduce risks associated with medication misadventures.
Final regulation was issued on March 11 to provide new, easy-to-understand labeling on non-prescription drugs. The new labels will have a standardized format and will be easier for consumers to read and understand.

Agency currently developing proposed rule for prescription drug labeling and various labeling guidances. The goal is to make prescription drug labeling easier to access, read and use.

Public and advisory committee meetings were held to inform consumers and health care professionals about the Agency's work on making the pregnancy section of labeling more useful.

1998 National Telephone Survey completed, and findings now available.

Risk/Benefit Communication study of gender differences in risk communication completed; publication anticipated in early 2000.

Stronger Food Quality Assurance By the end of FY 2000, assure improved quality of the American food supply, through a collaborative system encompassing government and private sector stakeholders.* Eighty percent of the domestic seafood industry will be operating a system of preventive controls for safety as evidenced by functioning HACCP (Hazard Analysis Critical Control Point) plans. HACCP is a newly instituted, industry-based monitoring system, and represents one element in the President's multi-strategy Food Safety Initiative. FDA will be working closely with USDA, EPA and the Centers for Disease Control and Prevention (CDC) to implement this initiative.
* Assumes funding of the Food Safety Initiative through the year 2000.
All seafood firms have been HACCP inspected.

More partnerships are being initiated with states, leading to greater uniformity in inspections.

National Seafood HACCP data base has been established using standard HACCP inspection form. This means increased compatibility between FDA and states.

In evaluating the public health outcome of HACCP implementation in this industry, we feel that the Agency has met the intent of using HACCP as a strategy or to prevent microbial contamination of seafood produced in the United States.

Faster Access to Important New Medical Devices By the year 2000, reduce the review time for important medical devices by two-thirds or 67 percent. (Important medical devices are products that present a major clinical benefit or those that may pose a significant risk to patients). This will be accomplished by reinventing the screening and review process for product applications. The impact of this goal is that millions of Americans will have faster access to safe and effective medical devices. FDA is reinventing the medical device review process and redefining the concepts of high risk and high impact products. The new definition will be applied to establish a baseline to measure review time for important medical devices.
The goal to reduce review time for important medical devices has been raised from the original goal of 30% to two thirds or 67% -- this is based on a $7 million increase over FY 99 for premarket activities.

Final FY 99 performance was 74% of the PMA's reviewed on time.

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Web page updated by CB 2001-FEB-15.

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Goal	Full Goal Statement	Progress Highlights
More Efficient Drug Development	By the year 2000, reinvent the drug development and review process, thereby lowering the development costs and, more importantly, reducing by an average of one year the time required to bring important new drugs to the American public. FDA will accomplish this through early and frequent consultation with product sponsors, implementation of an automated application filing process and an electronic document management system, and reauthorization of an enhanced user fee program.	The Industry Meeting Tracking system (IMTS) is fully operational with review divisions entering meetings into the system. PDUFA meetings guidance to industry was issued in March and the comment period ended in May. Comments are currently being reviewed. Guidance on full electronic NDAs (for archive) was published. Agency is now ready to receive and review NDAs electronically. Previously, only case report forms and tabulations were being received and reviewed electronically. Guidance on submitting regulatory data for ANDAs in electronic form was published this fiscal year. Guidance on electronic ANDAs (for archive) will be published in FY 2001. The electronic document management system is operational. An enhanced version is under development and will be released later this year.
Better Medical Product Information	According to legislative mandate, 75 percent of all consumers receiving new drug prescriptions will be given more useful and readable information about their product by the year 2000. Usefulness is defined in terms of scientific accuracy, unbiased content and tone, specificity and comprehensiveness, and timeliness. Based on national surveys conducted by FDA, the percentage of people who received useful information on new drug prescriptions was only 32 percent in 1992. To achieve the 75 percent goal, FDA will work closely with industry, health care providers and the consumer. Simultaneously, FDA will revise prescription drug and OTC labels to make them more readable. These information and labeling initiatives will improve the accurate use of medications and reduce risks associated with medication misadventures.	Final regulation was issued on March 11 to provide new, easy-to-understand labeling on non-prescription drugs. The new labels will have a standardized format and will be easier for consumers to read and understand. Agency currently developing proposed rule for prescription drug labeling and various labeling guidances. The goal is to make prescription drug labeling easier to access, read and use. Public and advisory committee meetings were held to inform consumers and health care professionals about the Agency's work on making the pregnancy section of labeling more useful. 1998 National Telephone Survey completed, and findings now available. Risk/Benefit Communication study of gender differences in risk communication completed; publication anticipated in early 2000.
Stronger Food Quality Assurance	By the end of FY 2000, assure improved quality of the American food supply, through a collaborative system encompassing government and private sector stakeholders.* Eighty percent of the domestic seafood industry will be operating a system of preventive controls for safety as evidenced by functioning HACCP (Hazard Analysis Critical Control Point) plans. HACCP is a newly instituted, industry-based monitoring system, and represents one element in the President's multi-strategy Food Safety Initiative. FDA will be working closely with USDA, EPA and the Centers for Disease Control and Prevention (CDC) to implement this initiative. * Assumes funding of the Food Safety Initiative through the year 2000.	All seafood firms have been HACCP inspected. More partnerships are being initiated with states, leading to greater uniformity in inspections. National Seafood HACCP data base has been established using standard HACCP inspection form. This means increased compatibility between FDA and states. In evaluating the public health outcome of HACCP implementation in this industry, we feel that the Agency has met the intent of using HACCP as a strategy or to prevent microbial contamination of seafood produced in the United States.
Faster Access to Important New Medical Devices	By the year 2000, reduce the review time for important medical devices by two-thirds or 67 percent. (Important medical devices are products that present a major clinical benefit or those that may pose a significant risk to patients). This will be accomplished by reinventing the screening and review process for product applications. The impact of this goal is that millions of Americans will have faster access to safe and effective medical devices. FDA is reinventing the medical device review process and redefining the concepts of high risk and high impact products. The new definition will be applied to establish a baseline to measure review time for important medical devices.	The goal to reduce review time for important medical devices has been raised from the original goal of 30% to two thirds or 67% -- this is based on a $7 million increase over FY 99 for premarket activities. Final FY 99 performance was 74% of the PMA's reviewed on time.