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The following is an excerpt describing this initiative from FDA's FY 2004 Annual Performance Plan.
Problem
Desired Outcome
Key Strategies
FY 2004 Goal Highlights
Current Status
FY 2002 Performance Goals
FY 2001-2002 Highlights
Related Information
FDA oversees the public health standards of an industry that produces almost $1.5 trillion worth of regulated products. The products include the entire food supply, except for meat and poultry; over-the-counter and prescription medications; blood products; vaccines; tissues for transplantation; medical equipment and implantable devices; devices that emit radiation; animal drugs and feeds; and cosmetics.
FDA faces two challenges in assuring that U.S. citizens fully reap the health benefits of modern medical technology, and enjoy a safe and nutritious food supply:
1. FDA must assure the safety and effectiveness of drugs, biologics, food additives, medicated animal feeds, and medical devices before they are allowed on the market. This challenge means keeping pace with the increasing scientific complexity of products that emerge from a $50 billion a year research and development effort. FDA scientists must accurately judge the readiness of these products to be marketed, and help these innovative products reach the market as quickly as possible.
There must also be a sufficient number of reviewers to handle the product review workload to provide timely feedback to application sponsors to identify and address deficiencies. Any delays might:
2. FDA must also monitor the safety of products once they are on the market. U.S. consumers spend an estimated $326 billion annually on medical products that are produced world-wide, and make their way to the market throughout a wide variety of distribution channels.
To ensure that these products are safe, the Agency must oversee their entire life cycle -- from production through distribution, and use/consumption.
FDA's long-term goal is to contribute to improving the health status of U.S. citizens by minimizing the risks associated with use of medical products and the consumption of food in the U.S. This becomes more likely when informed consumers and health professionals make wise choices concerning the dissemination and use of these products. FDA is examining specific outcome measures that will reflect progress towards this goal, and will be working to identify data sources to accurately measure this progress.
FDA recognizes that improvements in U.S. public health will only be possible through a coordinated effort on the part of many partners in the public and private sectors, as well as the consumer. In this joint effort, FDA makes a significant contribution in several ways:
These multiple roles will contribute greatly to the availability and appropriate use/ consumption of FDA-regulated products. Although product availability and safe use are still only part of the equation they are necessary ingredients that must be present to improve public health outcomes.
The discussion that follows outlines specific strategies that FDA is embarking on in the areas of premarket review, postmarket inspection and enforcement; and risk analysis that underpin the entire effort:
Premarket
Postmarket
Premarket Review
Human Drugs and Biologics:   For new drugs and biologics, the story is one of great success. FDA has moved from criticisms of a "drug lag" with other countries a decade ago to the current situation in which new drugs are approved in the U.S. as fast as or faster than anywhere in the world, with the same high standards Americans expect. This was accomplished largely by the assurance of sufficient scientific staff funded by industry fees that supplement appropriated funds.
Generic Drugs:   In the area of generic drugs, recent increases have enabled the program to raise performance targets.
OTC Drugs:   For over-the-counter (OTC) drugs, the FDA has finalized 52 monographs or "recipes" for marketing these drug products without the need for FDA preclearance. The monographs save manufacturers costs and reduce barriers to competition, as they allow both large and small companies to enter the market place with OTC drug products that have to meet the same, uniform criteria. By the end of FY 2004, the Agency expects to have initiated the review process (e.g. submit as advance notice of proposed rulemaking (ANPR)) for as many as 110 major drug category monographs. In the next 10 years, FDA expects to review and complete approximately 25 monographs, a number of which are major product categories (e.g. internal and external analgesic, and health care antiseptics). The road from ANPR to when a monograph is finalized is a complex and time-consuming rule-making process and can take several years.
Pediatric Medicine:   The original pediatric exclusivity provision of FDAMA has done more to generate clinical studies and useful prescribing information for the pediatric population than any other regulatory or legislative process to date. As a result of this provision, FDA has worked with NIH to develop off-patent drugs and to elicit study proposals from industry. FDA has issued over one hundred written requests for studies that could affect thousands of pediatric patients. The Agency has also issued a number of grants of pediatric exclusivity. The Best Pharmaceuticals for Children Act (BPCA), enacted on January 4, 2002, will continue to provide incentives for the effective development and dissemination of information on how to properly use therapies in children.
Postmarket
Global Vigilance - Imports of all FDA regulated products have been increasing over the last several years - growing at an annual rate of 10 to 12 percent. In FY 2001, FDA physically examined less than one percent of all entries offered for import into the United States. Plans for a highly integrated web-enabled import monitoring system are being developed to allow the Agency to prevent unsafe import entries on a cost-effective basis. Alternatively, FDA would need restructured regulatory authority that would place more responsibility on exporters to assure that products entering the U.S. are safe.
Domestic Industry Monitoring - The law requires that FDA inspect certain biologics, human and animal drugs and feeds, and medical device manufacturers at least once every two years. Although at least 50 percent of statutory establishments should be inspected annually, only 19 percent of human drug, and 20 percent of medical device statutory establishments were inspected in FY 2001. However, the Agency did exceed its goal in inspecting over 50 percent of registered blood banks, source plasma operations, and biologics manufacturing establishments in FY 2001. Beginning in FY 2003, FDA has developed a new high risk performance goal to inspect the highest risk drug manufacturers.
Program |
Final FY 2002 Goal Statement |
Was the target met? |
Explanation |
---|---|---|---|
Foods |
Complete review and action on 60% of food and color additive petitions within 360 days of receipt. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until at least 360 days after the end of the fiscal year. |
Foods |
Respond to 95% of notifications for dietary supplements containing "new dietary ingredients" within 75 days. |
Yes |
|
Foods |
Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000 samples. |
Yes |
|
Human Drugs |
Complete review and action on 90% of Standard NDAs within 10 months and 90% of Priority NDAs within 6 months. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until at least 6 and 10 months after the end of the fiscal year. |
Human Drugs |
Complete review and action on 65% of fileable original generic drug applications within 6 months after submission date. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until at least 6 months after the end of the fiscal year. |
Human Drugs |
Improve the capability and efficiency of pharmaceutical development and manufacturing by conducting laboratory research on at least 3 projects. |
Yes |
|
Human Drugs |
Inspect 20% of registered human drug manufacturers, repackers, relabelers and medical gas repackers. |
Yes |
|
Human Drugs |
Protect human research subjects who participate in drug studies and assess the quality of data from these studies by conducting 780 onsite inspections and data audits annually. |
No |
In FY 2002, there was a reduction in the number of NDAs submitted and this reduced the number of completed inspections. |
Human Drugs |
Increase the number of drugs that are adequately labeled for children by implementing, evaluating, tracking and reporting on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule. |
Yes |
|
Biologics |
Complete review and action on 90% of standard PDUFA NDA/ PLA/ BLAs within 10 months and 90% of priority PDUFA NDA/ PLA/ BLAs within 6 months. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until at least 6 and 10 months after the end of the fiscal year. |
Biologics |
Complete review and action on 90% of standard PDUFA efficacy supplements within 10 months and 90% of priority PDUFA efficacy supplements within 6 months. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until at least 6 and 10 months after the end of the fiscal year. |
Biologics |
Complete review and action on 90% of PDUFA manufacturing supplements within 6 months of receipt and 90% of PDUFA manufacturing supplements requiring prior approval within 4 months of receipt. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until at least 6 and 10 months after the end of the fiscal year. |
Biologics |
Complete review and action on 90% of Class 1 resubmitted original PDUFA applications within 2 months and 90% of Class 2 resubmitted original PDUFA applications within 6 months of receipt. |
Data Not Yet Available |
Although we met the 2 month target, and we expect to meet the 6 month target for this review goal, the final data won't be in until at least 6 months after the end of the fiscal year. |
Biologics |
Complete review and action on 90% of complete blood bank and source plasma PLA/BLA submissions, and 90% of PLA/BLA supplements within 12 months after submission date. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until at least 6 and 10 months after the end of the fiscal year. |
Biologics |
Meet the biennial inspection statutory requirement by inspecting 50% of registered blood banks, source plasma operations and biologics manufacturing establishments to reduce the risk of product contamination. |
Yes |
|
Animal Drugs and Feeds |
Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80%. |
Yes |
|
Animal Drugs and Feeds |
Pilot and validate the procedure for receiving protocol submissions electronically. |
Yes |
|
Animal Drugs and Feeds |
Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material. |
Yes |
|
Animal Drugs and Feeds |
Maintain biennial inspection coverage by inspecting 50% of registered animal drug and feed establishments. |
Yes |
|
Animal Drugs and Feeds |
Complete Review and Action on 50% of NADAs/ANADAs within 180 days of receipt. |
Yes |
|
Animal Drugs and Feeds |
Reduce pending overdue Animal Drug submissions by 15%. |
Yes |
|
Animal Drugs and Feeds |
Maintain isolate testing rate for Salmonella in the National Antimicrobial Resistance Monitoring System (NARMS) at 12,000. |
Data Not Yet Available |
Although we expect to meet the target for this review goal, the final data won't be in until March 2003. |
Medical Devices |
Complete 95% of PMA "Determination" meetings within 30 days. |
Yes |
|
Medical Devices |
Review and Act on 90% of Premarket Approval Application of an estimated 80 (PMA) first actions within 180 days. |
Yes |
|
Medical Devices |
Review and Act on 95% of an estimated 4,500 510(k) (Premarket Notification) first actions within 90 days. |
Yes |
|
Medical Devices |
Recognize 20 new or enhanced standards to be used in application review. |
Yes |
|
Medical Devices |
Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20%. |
Yes |
|
Medical Devices |
Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 9%. |
No |
The international climate after the terrorist attacks of September 11, adversely impacted foreign travel until well into the 1st quarter of FY 2002. As a result, only 209 out of a planned 225 inspections were completed. |
Medical Devices |
Ensure at least 97% of an estimated 8749 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. |
Yes |
|
Medical Devices |
Review and Act on 90% of PMA supplement final actions within 180 days. |
Yes |
|
Medical Devices |
Conduct 290 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.) |
Yes |
|
NCTR |
Conduct one biologically based mechanistic study combined with pre-dictive modeling to improve extrapolation of animal data to the human condition. |
Yes |
|
NCTR |
Support at least two multi-disciplined DNA and RNA-based microarray technologies. |
Yes |
|
NCTR |
Maintain existing computational databases of estrogenic and androgenic compounds for use by reviewers. |
Yes |
|
NCTR |
Initiate analytical/ biological studies to assess the toxicity of at least one, FDA high priority dietary supplement. |
Yes |
|
NCTR |
Report at scientific meetings and/or publish preliminary results on the development of new methodologies to identify genetically modified foods, drug residues in foods and antibiotic-resistant strains of bacteria. |
Yes |
|
NCTR |
Publish at least one scientific paper describing one technology for use in reviewing regulated compounds. |
Yes |
|
Medical Product Research Oversight
Human Drugs and Biologics
Medical Devices
FDA successfully negotiated the authorization of the Medical Device User Fee and Modernization Act (MDUFMA), which will give the Agency access to resources necessary to effectively support medical device development and expedite premarket application review.
In 2002, several new products were approved including:
Foods
Postmarket
Human Drugs and Biologics
Medical Devices
Foods
FDA took further steps to understand and manage the risk associated with dietary supplements, including the following:
BSE Risk Management
FDA participated in the USDA sponsored training of risk analysts to use and continue developing the Harvard Center for Risk Analysis (HCRA) BSE simulator. The simulator has been installed in FDA's Center for Veterinary Medicine (CVM) to run computationally-intense risk assessment and risk management models. FDA's Risk Analysis Team is running the simulator to test the impact on risk of BSE infectivity in cattle under alternative compliance strategies. The risk management approach to BSE risks in the U.S. enables FDA to make difficult resource allocation decisions under the scientific uncertainty attendant health risk issues.
Medical Products:
Medical Technology Initiative
Prescription Drug User Fee Act
Medical Device User Fee and Modernization Act of 2002
Current Good Manufacturing Practices (cGMP) for the 21st Century
Generic Drugs Final Rule and Initiative
Food and Dietary Supplements:
FDA Issues New Security Guidance as Part of Operation Liberty Shield to Protect
the Food Supply
HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra
FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements