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Budget Formulation and Presentation

Human Drugs Performance Goals

The following performance goal table summarizes the performance goals, yearly targets and actual reported data for the Human Drugs Program.

Given the uncertainty of final FY 2007 appropriation levels at the time FDA developed the performance targets for the FY 2008 Congressional Justification, FDA has included FY 2007 targets at both the President's Budget and the Continuing Resolution funding levels.

1. Improve the efficiency and effectiveness of the new drug review program to ensure a safe and effective drug supply is available. (12001) (Formerly: Ensure a safe and effective drug supply is available to the public.)

• Context of Goal: This performance goal focuses primarily on improving the effectiveness and efficiency with which the FDA processes new drug and biologics licensing applications. Central to that focus is FDA's commitment to meeting the goals and requirements of the Prescription Drug User Fee Act (PDUFA). The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products. FDA's timely performance of high-quality drug reviews in recent years reflects the importance of managerial reforms and substantial additional resources provided under the Prescription Drug User Fee Act (PDUFA). Consistent with the PDUFA requirements, a major objective of the human drugs program is to reduce the time required for review of all drugs, including therapeutic biologic products. A key determinant in knowing if CDER is making progress in reducing time is to measure the time to "first action." The first action is the first regulatory action CDER takes (complete response, approvable, not approvable, or approval letter) at the end of the review of the original NDA/BLA submission (the first review cycle). The "first action time" refers to the time it takes to review and take an action on the original submission. This statistic is different from "total approval time" which is the time it takes from the original receipt of the application until it is approved, which may take more than one review cycle. "Total approval time" includes time spent reviewing an application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the complete response or approvable/not approvable letter(s) and to re-submit the application for review. CDER's featured targets under this performance goal are to measure time to first action for "priority" submissions and "standard" submissions. Applications for drugs similar to those already marketed are designated standard, while priority applications represent drugs offering significant advances over existing treatments. (For example, drugs for Acquired Immune Deficiency Syndrome (AIDS) and cancer typically fall into the priority category.)
  
• Performance: CDER will not have the final performance numbers for the FY 2006 submission cohort until November 2007. The latest information on CDER's performance toward the targets for this performance goal is from FY 2005. In FY 2005, CDER met or exceeded almost all of the PDUFA review performance goals, including exceeding the goal for reviewing standard NDAs and BLAs, but fell short of the performance goal for priority review of NDAs and BLAs. Out of 32 priority applications filed, 4 missed their review goal. Three of the four applications were submitted by the same company. Complex inspection issues with the company arose during the course of review, which extended beyond the scope of these three applications, and prohibited a regulatory action from being taken until these issues were resolved. Review of Biologic License Applications (BLAs) for Therapeutic Biologic Products was transferred from CBER to CDER effective 10/1/2003, and these submissions are included in the table below. Performance toward the standard and priority NDA/BLA submissions, and other PDUFA goals, is provided in the following table:

Fiscal Year 2005 First Action Review Performance
(Performance data as of September 30, 2006)

2. Increase the number of drugs that are adequately labeled for children and ensure the surveillance of adverse events in the pediatric population. (12026)

• Context of Goal: The context of the Pediatric Program's performance goal in CDER covers the activities and requirements of the various laws passed to ensure safe and effective drug products are available for children. Due to the inadequacy of pediatric use information found in the majority of prescription medications in the United States, Congress passed several legislative initiatives to promote drug development for children. In 1997, the Food and Drug Administration Modernization Act (FDAMA) was signed into law with section 111 providing incentives to manufacturers who conduct studies in children. This incentive program, which provides six months of additional marketing exclusivity in return for conducting pediatric studies requested by the FDA, was reauthorized in January 2002 under the Best Pharmaceuticals for Children Act (BPCA). As a result of these initiatives, the number of ongoing pediatric clinical trials in the last 9 years has increased dramatically. Many of the studies reported to date have yielded new dosing and safety information in labeling.

The Pediatric and Maternal Health Staff, in coordination with FDA's Office of Pediatric Therapeutics, is required to report on adverse events for the first year of marketing following the granting of exclusivity under 505A of the Federal Food, Drug, and Cosmetic Act to the Pediatric Advisory Committee under section 17 of the BPCA.

On December 3, 2003, the Pediatric Research Equity Act (PREA) was enacted. This law provides FDA the authority to require pediatrics studies for certain new and already marketed drug and biological products. PREA incorporates many elements of the former "Pediatric Rule" (63 FR 66632, Dec. 2, 1998) that was struck down in U.S. District Court for the District of Columbia on October 17, 2002. The effective date of PREA is retroactive to April 1, 1999, the same date the former Pediatric Rule became effective. Due to the retroactive nature of the legislation, a significant number of previously submitted applications are now subject to the requirements.

• Performance: The target for FY 2006 performance was to issue at least 8 written requests for drugs that need to be studied in the pediatric population and report to the pediatric advisory committee on adverse events for 8 drugs that receive pediatric exclusivity. CDER issued 20 Written Requests: to sponsors of 18 for on-patent drugs to sponsors and 2 for drugs on NIH's annual Priority List, as required by the Best Pharmaceuticals for Children Act. CDER reported to 2 Pediatric Advisory Committees on adverse events for 12 drugs that received pediatric exclusivity.

In addition, CDER accomplished the following activities in FY 2006:

• Additional efforts were made related to Written Requests for the study of on-patent drugs in the pediatric population:
  • 33 amendments were issued to sponsors of existing Written Requests.
  • 4 on-patent Written Requests, declined by sponsors
• Exclusivity determinations were made once final study reports were submitted:
  • Final study reports were submitted for 19 drugs (partial and complete responses to Written Requests)
• Exclusivity determinations were made for 14 drugs
• Exclusivity was granted for 13 drugs
• Final pediatric labeling information was determined and information disseminated:
  • 12 labeling changes were made and posted on the web
  • Information was disseminated through 15 outside presentations/liaison activities and 6 publications.
• Medical/clinical pharmacology reviews were posted on the web for 9 drugs at the time of action, under the provisions of Section 9 of the BPCA. Related Federal Register notices were published.
• CDER worked with NIH to publish its annual Priority List of Drugs in the Federal Register, April 26, 2006

FDA is using several mechanisms to provide information on products for pediatric use:

• The Best Pharmaceuticals for Children Act (BPCA), enacted in January 2002, requires that FDA make publicly available a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for supplements submitted under the BPCA. A total of 67 summaries are now posted, regardless of the regulatory action, at http://www.fda.gov/cder/pediatric/Summaryreview.htm.
• BPCA mandates review of all adult and pediatric adverse event reports for a one-year period after pediatric exclusivity is granted and presentation of these reports to a pediatric advisory committee. As of November 16, 2006, reports have been presented for 65 drugs.
• FDA is working with companies to put more information on pediatric studies into the label even when the studies did not show efficacy for the indication studied.
• The Pediatric Research Equity Act (PREA), enacted December 2003, gave FDA the authority to require pediatric studies of certain pharmaceutical products when such studies are needed to ensure the safe and effective use of the products in children. However, PREA does not require the same public disclosure of pediatric studies that is required under the BPCA.
• FDA has worked with the American Academy of Pediatrics by having two liaisons to the Committee on Drugs and by funding a Continuing Medical Education Program that focuses on new pediatric drug labeling.

3. Improve the efficiency and effectiveness of the generic drug review program to ensure safer and more effective generic drug products are available for Americans. (12003) (Formerly: Ensure safe and effective generic drugs are available to the public.)

• Context of Goal: Generic drugs are widely known to be a cost-effective treatment alternative, costing consumers 20-70 percent less than brand-name drugs. According to the Congressional Budget Office, they save consumers an estimated $8 billion to $10 billion a year compared with the price of trade-name products. The basic requirements for approval of generic and trade-name drugs are the same as new drug approvals, although the generic drug manufacturer does not need to repeat the safety and efficacy studies conducted by the developer of the original product. Prior to approval, generic drug sponsors are required to demonstrate bioequivalence to the innovator drug product by showing that the active ingredient in their product is absorbed at a rate and extent similar to the innovator counterpart. The review action time is measured from the date the application is received to the date a major action, either an approval or not approvable, is reached.

With the significant increase in workload in the program, from 307 applications in FY 2001 to 793 in FY 2006, CDER is concerned about meeting its statutory obligations. Targets for FY 2007 and FY 2008 reflect FDA's performance toward the statutory ANDA review requirement given the new workload, planned resources for FY 2007, and proposed resources for FY 2008. These new targets assume that the number of applications considered to meet the performance measure will not include any applications with minor quality or data issues that could be addressed quickly and easily allowing an approval to take place shortly after the 180-day statutory deadline. The statutory deadline of 180 days acts as a disincentive to approving some applications when there are minor issues to be addressed because the application will 'cycle' through the review queue. FDA is striving to approve generic drug applications where possible in one review cycle which results in a direct benefit to the public health because generic drug alternatives will reach the market faster. FDA estimates that approximately 5% of applications at this point can be approved in one cycle without extending the review time very long after the 180-day statutory requirement. We believe that there is more of an incentive and benefit to the public for approving applications in one cycle whenever feasible than merely acting upon that application within 6 months.

• Performance: In FY 2005, OGD reviewed and acted upon 66% of 766 applications. OGD did not meet the performance target of 90% for a number of reasons. The target was proposed several years ago when receipts of new applications were half the number they are now. Further, despite the exponential increase in receipts, new resources to manage the increased workload have increased only marginally. The table below graphically illustrates the increase demand on the resources available to OGD.

In spite of a record year of receipts of new applications, in FY 2006 OGD was able to approve or tentatively approve 70% of the fastest ANDAs in under 14 months (a fraction of the proposed cohort goal). It also approved or tentatively approved a record 510 ANDAs. Also, in FY 2006, the Office was able to approve or tentatively approve 64 applications in one cycle. This represents an increase from 27 in FY 2005 and 3 in FY 2004. This was a result of an increased involvement in activities to assure more complete applications, increased direct communication with firms during the review process, and competent fully trained review staff. The communication also provides greater transparency and predictability for the sponsors.

4. Improve the efficiency and effectiveness of the over-the-counter (OTC) drug review program to ensure a safe and effective drug supply is available. (12048) (Formerly: Increase the number of drugs adequately labeled available for OTC use)

• Context of Goal: Over-the-counter (OTC) drugs play an increasingly vital role in America's health care system. The trend to self-medicate has increased greatly in recent years as health care costs have risen and consumers want to be empowered to treat minor ailments with OTC drug products. However, safety, effectiveness, and proper labeling have not always been characteristic of OTC drug products in the United States. FDA's goal by 2012 is to complete its existing review of OTC drug products, to have considered a number of key foreign drugs for marketing in the United States, and to have considered a number of key potential "prescription (Rx)-to-OTC" switches. OTC drug monographs are "recipes" for marketing OTC drug products without the need for FDA pre-clearance. The monographs list the allowed active ingredients and the dosage or concentration, the required labeling, and packaging and testing requirements if applicable. 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. Final monographs (agency final rules) need to be completed for a number of large product categories (e.g., external analgesics, internal analgesics, antimicrobials, oral health care products, laxatives). In the next5 years, FDA plans to complete the initial review of OTC monographs for 29 categories of drug products, thereby eliminating all unsafe and ineffective products from the OTC market. The ability to reach these goals will depend on maintaining experienced staff in all facets of rulemaking development and improvement in the efficiency of the FDA document clearance process.
  
• Performance: FDA exceeded its goal by completing review and action on 100% of Rx-to-OTC switch and direct to OTC applications within 10 months of receipt and making significant progress on 8 OTC monographs: (1) Internal Analgesic, Antipyretic, and Antirheumatic Drug Products - Organ Specific Warnings; (2) OTC Vaginal Contraceptive Products Containing N9 - Required Labeling (3) Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products - Nasal; Decongestants, Phenylephrine; (4) Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products - Nasal; Decongestants, Phenylpropanolamine (proposed rule published 12/05); (5) Skin Bleaching Drug Products (proposed rule published 8/06); (6) Sunscreen Drug Products; (7) Topical Antimicrobial Drug Products - Healthcare and Consumer Antiseptics; (8) Labeling for OTC Drug Product - Convenience Size Labeling Rule . The expansion of the OTC drug review to evaluate foreign OTC drugs is expected to increase switch requests in the near future. While CDER is hoping for a 50 percent increase in applications, we do not control the number of applications submitted. FDA recognizes that some of these switch requests involve issues of "OTCness" - determination that the drug is appropriate for OTC use and developing appropriate labeling and other information (such as was done for OTC stop smoking aid products) for safe and effective consumer use of these products without the intervention of a health care professional.

5. Reduce time to marketing approval for new drugs and biologics.

• Context of Goal: Reducing unnecessary delays in the approval time for safe and effective drugs that truly represent new therapies [i.e., new molecular entities (NMEs) and biologics] means earlier patient access for these medicines. Reducing unnecessary delays in drug approval also helps to both control the cost of new drug development, cited as a factor affecting the cost to consumers, and supports market competition among innovators. This is both good for the drug industry and good for consumers. New drug development presents uncertainties that increase the business risk and costs to the innovator. Higher costs can create barriers to competition both from new drugs with therapeutic value- but not blockbuster potential, and new innovators that don't have access to the capital available to more established pharmaceutical companies. Although some scientific and technical uncertainties are inherent and unavoidable in drug innovation, others can be reduced or eliminated, helping speed patient access to new drugs, and reducing the cost of drug development. FDA has begun major initiatives to reduce those sources of uncertainty.

Additional initiatives are included in the Agency's Strategic Action Plan. Sponsors, for example, may be uncertain about what FDA expects to see in a high quality new drug application, because of a lack of interaction with FDA during development, or lack of clear, timely or consistent FDA-sponsor communication during review. As a result, the submitted application may have deficiencies that could have been avoided or addressed quickly, but instead create unnecessary delays as they are identified by FDA and then addressed by the sponsor. Although FDA has found that applications can often contain deficiencies that are not so readily addressed, clear understandings of FDA expectations and timely communication between FDA and application sponsors can increase the likelihood that the submitted application contains the necessary information for timely approval on the first review cycle.

The targeted reductions in this FDA outcome goal represent approximately 10.5 percent reductions in total FDA review times for priority and standard NMEs and BLAs. Using Tufts estimates of potential cost reductions by phase of drug development, a 10 percent reduction in regulatory review time yields a 1.6 percent reduction in total capital costs, now estimated at $802 million, translating to a savings of $12.8 million per NME approved.

• Performance: The FDA approval time for the fastest 50 percent of standard NME and biologics licensing applications (BLAs) approved in CDER and CBER for the FY 2001-2003 cohort is 523 days as compared to 575 days for the baseline FY 1999-2001 submission cohort. This is a reduction of 52 days versus the FY 2005-2007 target of a reduction of 61 days. An update of progress on this goal for the FY 2004 submission cohort is not expected until May 2007.

6. Reduce the time to marketing approval or tentative approval for safe and effective new generic drugs.

• Context of Goal: FDA achievement of this goal will create earlier access to lower cost drug alternatives for patients. The high cost of drugs limits patient access to treatment. The lower income and uninsured populations are particularly affected. Research has shown that 42 percent of the uninsured do not fill prescriptions because of financial reasons. While all state Medicaid programs provide outpatient prescription drug coverage, slightly more than one in four Medicaid patients ages 18-64 could not afford to fill at least one prescription, according to a study by the Center for Studying Health System Change (HSC). Increasing the availability of generic drugs will make many important treatments more affordable to the poor and the elderly and significantly improve access to treatment.

Prescription drug expenditures remain one of fastest-growing segments of the U.S. health care system. In 2001, a 13.8 percent increase in drug spending accounted for one-fifth of the overall increase in health care spending. State Medicaid programs are particularly challenged with controlling escalating cost of pharmacy benefits and are in serious need of more generic alternatives to high cost brand name drugs to both reduce costs and increase access to treatment. Medicaid spending on outpatient drugs has increased by 18 percent a year from 1997- 2000, which is close to three times greater than increases in medical care spending.

Optimal access and use of generic drugs will enable policy decision makers to contain costs in both the Medicare and Medicaid programs. This will only become more important as more of the top selling brand name drugs go off patent over the next few years and if legislation for a Medicare drug benefit is passed by Congress. The National Institute for Healthcare Management has estimated that Medicaid programs could save $1 to $1.5 billion over the next few years if they were to increase their share of generic drug use to 55 percent of their total drug spending. According to researchers at Brandeis University, if a Medicare drug benefit were to be implemented and the use of generic drugs represented 50 percent of the total prescriptions, approximately $250 billion would be saved over 10 years.

Generic drugs are typically priced between 20-70 percent lower than brand name competitors, which represent a significant cost saving to consumers.

• Performance: The FDA approval time for the fastest 70 percent of original generic drug applications approved for the FY 2002-2004 cohort is 16.0 months as compared to 17.9 months for the baseline FY 1998-2000 submission cohort. This is a reduction of 1.9 months versus the FY 2005-2007 target of a reduction of 1.5 months. However, this progress may not hold in future years. Despite the exponential increase in receipts, new resources to manage the increased workload have increased only marginally. The table below graphically illustrates the increase demand on the resources available to OGD.

7. Enhance the protection of the American public against the effects of terrorist agents or natural disasters by facilitating the development of and access to medical countermeasures, providing follow-up assessments on therapies, and engaging in emergency preparedness and response activities. (12045)

• Context of Goal: In the Federal Government's response to a biological, chemical, or radiological/nuclear attack or to a natural disaster, drugs will be mobilized from the CDC's Strategic National Stockpile (SNS). However, not all drugs in the SNS are FDA-approved as countermeasures against threat agents or emerging infections. FDA has been taking an aggressive and proactive approach to identify and facilitate development of new therapeutic options as well as to obtain information on existing approved drugs that may be used for an unapproved indication. For example, although gentamicin has not been FDA-approved for treatment of plague, it is widely recommended as a preferred therapy by experts. Human clinical trial data and animal efficacy data will be needed to demonstrate safety and efficacy of gentamicin for specific plague treatments. Identification of gaps in the therapeutic armamentarium and development of a plan to address these gaps will move the FDA closer to a goal of labeling all drugs that reside in the SNS for counterterrorism uses. FDA is also active in department and agency efforts to prepare for other emergencies, such as natural disasters and pandemics.
  
• Performance: Efforts over the last five years have strengthened CDER's capability to prepare for and respond to biological, chemical, and radiological/nuclear threats and incidents. FDA is engaged in many efforts to promote the development of medical countermeasures. The Agency encourages early and frequent interactions with sponsors, whether they are developing a novel compound or a new indication for a previously approved product. Regulatory mechanisms, such as Fast Track Designation, use of surrogate markers, or development under the Animal Efficacy Rule, and guidance documents are available to accelerate submission and review. FDA continues efforts to expand the availability of safe and effective medical countermeasures for special populations (e.g., pregnant or lactating women, infants and children, the elderly). FDA is also engaged in efforts to prepare for a possible influenza pandemic by contributing to HHS strategic planning, developing its own plans, and interacting with industry on development of regulatory issues involving antiviral drugs. The following list describes the countermeasure performance for FY 2006:

CDER facilitated the development of and access to medical countermeasures through the following activities:

1. Approving Duodote (atropine and pralidoxime chloride injection) for use by trained emergency medical services personnel to treat civilians exposed to life-threatening organophosphorus-containing nerve agents, such as sarin, and insecticides. FDA previously approved atropine and pralidoxime chloride injection, under the name Antidote Treatment--Nerve Agent Auto-Injector (ATNAA), for military use.
2. Approving five abbreviated new drug applications for the first generic versions of Bayer Corporation Pharmaceutical Division's Cipro® I.V., a drug used to treat certain bacterial infections. Ciprofloxacin is approved for inhalational anthrax (post-exposure).
3. Extending the expiration date for Ca- and Zn-DTPA to 10 years, following re-examination of the stability data by CDER chemists. In February 2006, the Department of Health and Human Services (HHS) awarded a $21.9 million contract for the manufacture and delivery of Ca- and Zn-DTPA
4. Continuing collaboration with the CDC on development of the Home MedKit study designed to evaluate whether participants and members of their households follow instructions about proper storage, use, and maintenance of the MedKit.
5. Continuing to develop Home Preparation Instructions for amoxicillin, doxycycline, ciprofloxacin, and oseltamavir so that, in a terrorism or pandemic influenza event in which pediatric dosage forms are not available, tablets or capsules can be crushed with food to make mixtures that can be given to children who cannot swallow tablets.
6. Continuing to work with the CDC on the ongoing human trials of gentamicin in plague in Africa, as well as with the NIH/NIAID and USAMRIID on the monkey studies of gentamicin, ciprofloxacin, levofloxacin, ceftriaxone, and doxycycline in pneumonic plague. These studies were funded in previous years by CDER through interagency agreements with the CDC and NIAID, respectively. Enrollment for the third year of the human trials in Africa commenced in the Fall of 2006 and is expected to be completed in December 2007.
7. Continuing to facilitate the submission of applications for antidotes to chemical threat agents. Such applications would be eligible for priority review.
8. Reviewing information to support Emergency Use Authorizations of countermeasures against Category A biological threat agents and to mitigate the effects of acute radiation syndrome in the event of a nuclear/radiological attack.
9. Completing the development of procedures for conducting inspections of the Strategic National Stockpile (SNS) storage sites. Additionally, CDC collaborated with FDA to conduct a full day training session for ORA inspectors and other Center representatives pertaining to SNS cGMP quality assurance systems. These FDA inspections will ensure that SNS storage sites will be compliant with cGMP requirements. At the request of the SNS to FDA, CDER's Office of Counterterrorism and Emergency Coordination (OCTEC) coordinated the interagency dialog for two years between HHS, CDC (SNS), ORA, OGC, OCTPP, CDER, CDRH, and CBER.
10. Publishing the Guidance for Industry on "Internal Radioactive Contamination-Development of Decorporation Agents." The draft issued in 2005.
11. Collaborating on laboratory research within CDER. CDER's OCTEC and the Office of Pharmaceutical Science are investigating interactions between Prussian blue and tetracycline, to assure that these products would be fully effective if an event required administration of both countermeasures.

CDER engaged in emergency preparedness and response activities through the following:

1. Contributing to the efforts regarding enforcement action against carbinoxamine products. The agency issued a final guidance document outlining its approach to addressing medicines that are marketed without required FDA approval, and, in a related action, took enforcement action to stop the manufacturing of unapproved carbinoxamine-containing products because of safety concerns focused on their use in children under 2 years of age.
2. An Inter-departmental Shelf-Life Extension Program (SLEP) Rapid Response Team (RRT) was formed, co-chaired by CDER's OCTEC and ORA's Division of Field Science, to address the action item in the Homeland Security Council's National Strategy for Pandemic
3. Collaborating with NIH/NIAID on the "Development and Use of Antivirals for Pandemic Influenza Workshop," held November 2006.
4. Completing the development of a CDER Sit Room with 24/7 operational capabilities for managing emergencies that involve FDA/CDER.
5. Exercising the Office of Counterterrorism and Emergency Coordination's Continuity of Operations Plan by conducting an exercise where office staff evacuated the official worksite, reported to their homes, and functioned as a unit in a novel situation to accomplish simulated, yet realistic, tasks. Injects inserted during the exercise added complexity in order to test both personnel and equipment.
6. Providing 24/7 emergency coordination and notification capability to the Center through implementation of the CDER Emergency Coordinator position.

8. Improve safe and effective use of medical products with better information technology and effective risk/benefit communication. (12007) (Formerly: Enhance postmarketing drug safety.)

• Context of Goal: FDA recognizes now, more than ever, the need for protecting and advancing the public health, and the Agency has been focusing on new and better ways to perform this mission. We have taken steps to ensure better internal processes for deliberation of drug safety issues that ensure appropriate and independent consideration of all issues as well as a stronger ability to gather data about drug safety issues once a drug has been approved. Most importantly, we are working toward a policy of more transparency to ensure that patients and physicians have the most up-to-date and complete information necessary to make their treatment decisions.

To demonstrate our commitment and to measure our progress on this initiative, we have proposed a performance target for FY 2006 that focuses on the establishment of the new risk communication processes. For example, we will establish criteria for determining what drug products should be listed on the CDER web page.

In FY 2007, we expect to be able to continue progress on this initiative, and we commit to evaluating our new risk communication processes and to establishing a tracking system for safety issues and action on those issues. In FY 2008 we will focus on standardizing the communication tools we use to provide risk information to patients and healthcare providers.

• Performance: As example of progress toward the FY 2006 target to standardize Agency processes and criteria for communicating risk information to patients and healthcare providers, in January 2006, FDA issued a draft guidance to industry called "Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format. The FY 2005 target for this performance goal involves reviewing and providing comments on Risk Minimization Action Plans (RiskMAPs) for new molecular entities (NMEs) and for those products for which the sponsor or FDA initiated discussions, in accordance with applicable PDUFA. CDER met this performance target. Further, CDER is making progress toward the new drug safety initiative described within the context of the goal to improve the safe use of drugs. For example, we are updating drug safety information on certain drug products -- including new molecular entities, drugs with medication guides, and drugs with known safety issues -- and making that available to consumers in a new, user friendly format. We have recently updated our website (http://www.fda.gov/cder/drugSafety.htm) to reflect our advancements to date.

9. Context of Goal: Increase the efficiency of the Adverse Event Reporting Process by reducing the average cost associated with turning a submitted Adverse Event Report into a verified record in the database. (12053)

• Context of Goal: A crucial part of FDA's mission is to perform pre-market and post-market safety and efficacy assessments of human drugs and therapeutic biologics. Clinical trials that lead to formal marketing approval only begin to quantify the safety and efficacy of a given pharmaceutical compound or biological product. The collection and analysis of data by FDA staff must occur throughout the entire life cycle of the product in order to identify unexpected safety risks associated with the use of a human drug that could not have been predicted by clinical trials and biostatistical analysis. These unexpected safety problems, called adverse events, must be reported to FDA in order for the agency to carry out its mission of performing post-marketing safety surveillance (PMSS). The Adverse Event Reporting System (AERS) is a computing system that FDA staff uses to carry out the PMSS function.

The AERS system is a critical component of FDA's post-marketing safety surveillance systems for all drug and therapeutic biologic products. The information captured in the AERS system allows FDA scientists and statisticians to search for patterns that may indicate an emerging safety hazard, which is the first step in analyzing the potential causes and formulating an effective risk management response. In FY 2006, about 95% of the adverse event reports relating to drugs and therapeutic biologics were submitted by manufacturers, who are required to submit expedited reports of serious events within 15 days, and periodic reports for less serious events. The remaining 5% of the drug and therapeutic biologic adverse event reports received by FDA are "direct" reports from health care providers, pharmacists, and citizens, which must be re-keyed into the AERS system. Overall, only about 35% of the total adverse event reports were submitted electronically in FY 2006. However, FDA received approximately 56% of the expedited reports electronically.

The manual entry of data into AERS is time-consuming and costly. Overall, the operating costs of the activities and systems covered by this goal represent approximately 12% of FDA's estimated total annual expenditures on post-market drug safety activities. The costs included in the measure include both information system operation and maintenance and scientific and technical staff time to process the records and perform quality control.

The current AERS system was released in November 1997 to support post-market safety surveillance. Initially, AERS captured information from over 200,000 adverse event reports per year and enabled electronic retrieval of information for agency reporting of adverse reactions to drugs and therapeutic biologics marketed in the United States. Since that time the total number of adverse event reports has grown to over 400,000 per year. Moreover, between 1992 and 2004, the number of manufacturer reports of serious and unexpected adverse events (the so-called Manufacturer 15-day reports, which represent a subset of the total number of adverse event reports) has grown almost 9-fold (see the figure below). The current cost of processing each AER presents a major obstacle to FDA's ability to keep up with and analyze the rapidly increasing volume of reports and to rapidly identify, assess, and manage emerging safety risks.

FDA is making the AERS system more efficient by improving the data entry work processes and reengineering the system to increase the percentage of electronic submissions, to reduce the amount of re-keying, to increase the number of submissions that are "pre-MedDRA coded," along with other efficiencies. These system improvements will allow the FDA to reduce the average cost and time associated with turning a submitted Adverse Event Report into a verified record in the database. This improvement in efficiency will allow scientists and statisticians to access safety information sooner, and will free up resources that can be redirected to risk analysis activities that directly improve our ability to recognize and respond to drug safety problems.

• Performance: The average cost associated with turning a submitted Adverse Event Report into a verified record in the database has been decreasing since FY 2003 due to FDA efforts to streamline its business processes and improve the information systems that are used to process records. In FY 2003, the cost per report was $21.91/per report. In FY 2004, the cost per report was $19.30/per report. In FY 2005, the cost per report was $17.35/per report. In FY 2006, the cost per report was $16.47/per report. FDA expects to achieve further improvements in efficiencies due to improved automation of the submission and validation processes, and outreach to improve adoption of electronic submissions. The proposed FY 2007 target of $15 per report represents almost a 32% reduction in cost per adverse event report compared to the FY 2003 level, not including inflationary impacts.

10. Reduce medication errors in hospitals through increased adoption of bar code medication administration technology.

• Context of Goal: In November 1999, the Institute of Medicine released a report estimating that as many as 98,000 patients die from medical errors in hospitals alone. Many of these deaths, as well as additional non-fatal illnesses, are associated with errors involving FDA regulated medical products, especially medications. A significant percentage of drug related mortality and morbidity results from errors that are preventable. In addition to their human cost, these errors impose significant economic costs on the U.S. health care system. The total cost of preventable adverse events has been estimated at $17 Billion. Preventing some of the adverse drug events related to medication errors in U.S. hospitals will significantly reduce related morbidity, mortality and health care costs.

The Secretary of Health and Human Services directed FDA to promulgate the bar coding regulation to reduce preventable errors from medical products. This rule is expected to enable the uptake and use of bar code scanners that will allow a health professional to compare the bar code on a human drug product to a specific patient's drug regimen and then verify that the right patient is receiving the right drug, at the right dose, via the right route, at the right time. Research to date has demonstrated the ability of bar code scanners at the point of care to intercept errors in dispensing and administration of medications and thereby prevent related adverse events. Consequently, this measure tracks the adoption rate of bar code medication administration technology in hospitals, with the expectation that increased adoption rates will be directly related to decreased medication error-related adverse events.

• Performance: The results of the American Society of Health-System Pharmacists (ASHP) 2006 annual survey of pharmacy practice in hospital settings (dispensing and administration) will be published soon (scheduled for 3/1/07). Over the last few years the adoption rate of bar code medication administration technology has grown each year, up to 9.4% overall in 2005, with a slightly higher rate of adoption in larger hospitals. The differentiation between small and large hospitals is becoming less each year.

11. Increase risk-based compliance and enforcement activities to ensure drug product quality. [Inspections of foreign and domestic establishments identified as high risk human drug manufacturers.] (12020)

• Context of Goal: FDA is continuing to develop a more quantitative risk model to help predict where FDA's inspections are most likely to achieve the greatest public health impact. The Risk-Based Site Selection Model provides a risk score for each facility, which is a function of four component risk factors- Product, Process, Facility, and Knowledge. The product component relates to the intrinsic risk associated with the products manufactured at a site. The process component relates to the complexity of the processes used at a manufacturing site, the difficulty associated with controlling the processes, and the susceptibility of the processes to contamination. The facility score considers a facility's compliance history, defect reports associated with a facility, sales production as a surrogate of production volume, and the type of establishment. The knowledge component factors in the duration since the last Current Good Manufacturing Practices (CGMP) inspection.

For the FY 2007 model, the Agency is developing several enhancements and improvements. For example, recalls will be connected to the facilities responsible for the recalls and factored into the facility risk score. This modification will improve the risk orientation of this performance goal by increasing the risk scores of those facilities more frequently associated with product defects. During this fiscal year, the Agency will also explore ways to enhance our calculations of process risk and facility sub-scores.

As enhancements are made to FDA's data collection efforts and to the Risk-Based Site Selection Model, FDA will improve its ability to focus inspections on the highest-risk public health concerns in a cost-effective way.

New for FY 2007, the risk prioritization scoring methodology was applied to about 2,000 non-US facilities manufacturing drugs for the US market (the number of drug facilities that received an inspection by FDA in recent years). Of these 2,000, approximately 100 scored high enough to be included in the FY 2007 FDA high risk category inspection priorities. FDA does not inspect non-U.S. facilities at the same frequency expected for U.S. facilities. With these considerations, FDA plans to inspect 500 high risk drug sites in FY 2007, including at least 25 non-US facilities high risk sites.

• Performance: FDA exceeded the FY 2006 goal of 483 by inspecting 510 high-risk firms.

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