Detailed Information on the
Food and Drug Administration Assessment

FDA will track FDA performance on new long-term outcome goals.

FDA is conducting evaluations of the new human drug program under the PDUFA III performance management program, which are expected to yield efficiency improvements and contribute to the accomplishment of long-term outcome goals regarding new drug approval times.

FDA is improving processes to increase the productivity of the generic drugs program, which also will yield efficiency improvements and contribute to the accomplishment of long-term outcome goals regarding generic drug approval times.

Is requesting additional food defense resources to support the achievement of FDA's lab surge capacity targets.

FDA is developing an efficiency measure for the FY 2007 Budget.

Measure: Reduce time to marketing approval for new drugs and biologics

Explanation:This measure tracks the number of days it takes for a new drug, or biologic to be approved for sale on the market. There are two targets for this goal, one for standard applications and one for priority applications. The targets and actual data for the standard applications are listed below.

Measure: Percentage of new drug product reviews completed within 10 months.

Explanation:This measure tracks the percentage of new drug and biologic applications that FDA reviews within the performance target. This measure has two targets, one for standard applications, one for priority applications. The targets and actual data for the standard applications are listed below.

Measure: Reduce the average time for marketing approval for safe and effective new devices.

Explanation:This measure tracks the number of days it takes to reach a final decision on new medical device applications. There are two targets for this goal, one for Standard PMAs, and one for Expedited PMAs. The targets and actual data of the Standard PMAs are listed below.

Measure: Percentage of FDA reviews of new medical devices completed within 180 days.

Explanation:This measure tracks the percentage of new medical device applications that FDA reviews within the performance target.

Measure: Reduce time to marketing approval for generic drug applications.

Explanation:This measure tracks the amount of months it takes for a generic drug to be approved for sale on the market.

Measure: Percentage of new generic drug application reviews completed in six months.

Explanation:This measure tracks the percentage of generic drug applications that FDA reviews within six months. Although FDA has worked very hard to improve the Generic Drug review process, a larger than expected increase in the number of submissions has caused FDA to miss the FY 2005 target. The FY 2007 and 2008 targets have been adjusted based on the projected workload and a proposed Generic Drug User Fee that will enable FDA to hire more reviewers.

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

Explanation:This measure tracks the adoption rate of bar code medication administration technology in hospitals. Evidence shows that this technology reduces medication administration errors.

Measure: Increase by 40 percent the percentage of American consumers who correctly identify that trans fat increases the risk of heart disease. (Baseline FY 2005 developed. Target year for accomplishment, FY 2007)

Explanation:This measure tracks the percentage of consumers who can correctly identify that trans fat increases the risk of heart disease.

Measure: Increase by 10 percent the percentage of American consumers who correctly identify that saturated fat increases the risk of heart disease. (Baseline FY 2005 developed. Target year for accomplishment, FY 2007.)

Explanation:This measure tracks the percentage of consumers who can correctly identify that saturated fat increases the risk of heart disease.

Measure: Improve by 10 percent the percentage of American consumers who correctly identify that omega-3 fat is a possible factor in reducing the risk of heart disease. (Baseline FY 2005 developed. Target year for accomplishment FY 2007.)

Explanation:This measure tracks the percentage of consumers who can correctly identify that omega-3 fat reduces the risk of heart disease.

Measure: Increase laboratory surge capacity in the event of terrorist attack on the food supply.

Explanation:This measure tracks FDA's ability to increase capacity to effectively analyze food samples for contamination in the event of a terrorist attack on the food supply.

Measure: Inspect blood banks and biologics manufacturing establishments each year.

Explanation:This measure tracks the percentage of blood banks and biologics manufacturing establishments inspected by FDA each year.

Measure: Inspect medical device manufacturing establishments each year.

Explanation:This measure tracks the percentage of medical device manufacturing establishments inspected by the FDA each year.

Measure: Percentage of Expedited PMAs reviewed and decided upon within 300 days

Explanation:This measure tracks the percentage of Expedited PMAs that FDA reviews and decides on within the performance target. This is a new annual performance goal that started in FY 2005.

Measure: Reduce the Unit Cost associated with turning a submitted Adverse Event Report into a verified record in the database.

Explanation:This measure tracks the unit cost associated with turning a submitted Adverse Event Report into a verified record in the database. This information 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. FDA is improving the data entry work processes and reengineering the system to increase the percentage of electronic submissions, to reduce the amount of manual re-keying, along with other efficiencies.

Is the program purpose clear?

Explanation: The Food and Drug Administration (FDA) has a very clear mission: to keep human drugs, vaccines, medical devices, animal drugs, and foods and cosmetic products safe. This mission, while applicable to a very wide range of products, is focused and well-defined.

Evidence: FDA Mission Statement: 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. Also, each FDA Center has their own specialized Mission Statement as well.

Does the program address a specific and existing problem, interest, or need?

Explanation: There is a clear need for a safe food supply and safe and effective human drugs, devices, vaccines, and animal drugs. The public health ramifications of foodborne illness are substantial, and certain populations, such as infants and the elderly, are more susceptible to foodborne illnesses. It is in the public interest to ensure that drugs, medical devices, and vaccines made available to the public are safe and effective given the high utilization rates of these products.

Evidence: CDC estimates that 76 million people get sick, more than 300,000 are hospitalized, and 5,000 Americans die each year from foodborne illness. Rapidly evolving technology used in products such as medical devices and human drugs increases FDA's role in reviewing new products for safety and effectiveness. Childhood vaccination utilization rates are very high in the U.S. -- vaccines are reviewed by FDA. It is estimated that 14 million units of blood are donated in the U.S. every year, and FDA is the Federal agency responsible for the safety of the blood supply.

Is the program designed so that it is not redundant or duplicative of any Federal, state, local or private effort?

Explanation: No State or local government agencies are responsible for the safety of prescription or over the counter drugs, medical devices, or vaccines. FDA is the sole agency responsible for ensuring the safety and effectiveness of these products. There is a State government role in food safety (through State Agriculture Departments). However, FDA provides Federal food safety standards, and facilitates international commerce. The Federal role in food safety is substantial.

Evidence: FDA plans to conduct at least 48,000 examinations of imported products in FY 2004. The FDA Center for Food Safety and Applied Nutrition (CFSAN) estimates that they regulate $1 for every $10 spent in the U.S. FDA reviews hundreds of applications for important new products such as medical devices, prescription drugs, and biologics every year, and it is FDAs responsibility to make sure that these products are available to the consumer as quickly as possible while still ensuring their safety and effectiveness.

Is the program design free of major flaws that would limit the program's effectiveness or efficiency?

Explanation: Current FDA structure is, in general, effective for the review of new drugs, devices, vaccines, and food additives. Given the legislative mandate of the FDA, and the wide range of products regulated by the agency, a system of compliance assistance and oversight is appropriate and effective. There are some inefficiencies present, such as the "triggers" for prescription drug and medical device user fess, that essentially preclude aggressive savings from management reforms. Also, while the fragmented structure of the Federal food safety system does not necessarily create duplications, it can result in some inefficiencies and complications.

Evidence: Pre-market review of new products ensures safety and effectiveness before the product is made available to consumers. Post-market activities ensure that products available on the market remain safe for consumer use, and are manufactured consistent with existing regulations.

Is the program effectively targeted, so program resources reach intended beneficiaries and/or otherwise address the program's purpose directly?

Explanation: FDA funding is targeted effectively to achieve program purposes. The vast majority of FDA resources is devoted to the key activities of pre-market review of new products and post market surveillance of approved products. Central administrative funding for the agency is relatively low in relationship to the entire FDA budget.

Evidence: In FY 2003, funding devoted to central administration at FDA was less than seven percent of the entire agency appropriation. The vast majority of FDA appropriations are devoted to key agency functions.

Does the program have a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the program?

Explanation: FDA has created a new set of long-term outcome goals that measure activities conducted at each program Center in the agency. The goals are intended to mesh with FDA's new Strategic Plan, and focus on several key FDA activities, including pre-market review, patient safety, consumer information, and counter-terrorism.

Evidence: The FDA FY 2005 Budget will include long-term outcome goals (with measurable targets). Selected long-term outcome goals include reducing the total time to market for new drugs, biologics, and devices; and increase the percentage of consumers who understand the relationship between dietary choices and coronary heart disease.

Does the program have ambitious targets and timeframes for its long-term measures?

Explanation: FDA's new long-term outcome goals have ambitious targets and timeframes for completion. Many of these goals reflect areas where FDA performance has never been measured, making the goals and the targets more ambitious.

Evidence: The targets for the new long-term outcome goals will be detailed in the FY 2005 Performance Plan. These targets will be measurable, and will be compared to baseline data.

Does the program have a limited number of specific annual performance measures that demonstrate progress toward achieving the program's long-term measures?

Explanation: FDA has had annual performance measures for many years. These measures cover nearly every FDA activity. Many of these measures are mandated by the FDA authorizing statute, and others were created by FDA.

Evidence: The FDA FY 2005 Budget will include annual performance measures very similar to those found in recent years. Selected measures include: rates of inspection coverage at regulated manufacturing establishments, FDA decision times on pre-market review applications, and examinations of imported foods and other FDA-regulated products.

Does the program have baselines and ambitious targets and timeframes for its annual measures?

Explanation: For pre-market review and inspection goals, performance targets are often set by statute, or in the case of user fee funded review activities, are negotiated with regulated industry in a "goals letter" that accompanies the user fee legislation.

Evidence: The annual FDA Performance Plan includes actual performance data going back several years to allow for a comparison of recent and proposed performance levels on annual performance goals.

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, etc.) commit to and work toward the annual and/or long-term goals of the program?

Explanation: FDA has established a protocol to ensure that all of its partners, whether contractors, partners or grantees, are committed to Agency long term goals in each initiative that is undertaken. This includes setting clear expectations on performance, agreement on a strategy to achieve performance goals, and monitoring.

Evidence: FDA has developed positive collaborations with the U. of Maryland on the Joint Institute for Food Safety and Applied Nutrition with clearly outlined performance expectations. The laboratory exchange network (eLEXNET) with States and other Federal agencies ties in tom FDA food safety-related goals. FDA outlines clear performance expectations for States involved in the inspection of mammography facilities.

Are independent and quality evaluations of sufficient scope and quality conducted on a regular basis or as needed to support program improvements and evaluate effectiveness and relevance to the problem, interest, or need?

Explanation: FDA is a frequent subject of evaluations from the academic community, think tanks, and governmental agencies such as GAO and the HHS Inspector General. While evaluations generally cover the entire agency, certain areas, such as food safety, prescription drugs, and biologics, tend to receive more attention from evaluators.

Evidence: Several evaluations of FDA can be found on the websites of the GAO (www.gao.gov) and the HHS OIG (www.oig.hhs.gov).

Are Budget requests explicitly tied to accomplishment of the annual and long-term performance goals, and are the resource needs presented in a complete and transparent manner in the program's budget?

Explanation: Budget requests are made to assist FDA in the achievement of annual goals. The FY 2005 Budget will be the first year that long-term goals will be included, and this budget will be tied to the achievement of the new long-term outcome goals. Resources in the budget are transparently tied to agency activities.

Evidence: The annual FDA Performance Plan and the Congressional Budget Justification include data on the relationship between budget and performance estimates.

Has the program taken meaningful steps to correct its strategic planning deficiencies?

Explanation: FDA is strong in strategic planning. The creation of the new Strategic Plan spurred the formation of a detailed, lengthy list of actions items that create timelines and accountability for meeting the agency's long-term outcome goals and annual performance goals. One FDA Center, CFSAN, has been completing a similar "Program Priorities" report for several years. The CFSAN report details a wide range of goals and action items. The report is updated to show actual performance, and to explain how the goal will be met if performance is lower than expected.

Evidence: The new FDA Strategic Plan will be available by late July, 2003. The CFSAN Program Priorities report is made available o the public on the FDA Internet site. The web address for the most recent edition of the report is:www.cfsan.fda.gov/~dms/cfsan702.html

Are all regulations issued by the program/agency necessary to meet the stated goals of the program, and do all regulations clearly indicate how the rules contribute to achievement of the goals?

Explanation:  

Evidence:  

Does the agency regularly collect timely and credible performance information, including information from key program partners, and use it to manage the program and improve performance?

Explanation: FDA collects a substantial amount of data on a variety of agency activities, and uses this data to manage agency performance. Detailed data are available on a range of pre-market review activities across the agency, and on rates of inspection coverage across FDA.

Evidence: The annual FDA Performance Plan includes a large amount of performance data and information. Much of this data is collected by field information systems, and other internal information tracking systems.

Are Federal managers and program partners (grantees, subgrantees, contractors, cost-sharing partners, etc.) held accountable for cost, schedule and performance results?

Explanation: FDA managers are held accountable for achievement of the agency performance goals. FDA supervisors across the agency sign performance contracts, linking their evaluations with the achievement of performance goals. In cases where activities related to performance goals are contracted out to contractors (such as third party review of certain medical devices), activities are audited by the FDA.

Evidence: Many FDA managers across the agency have as part of their annual performance evaluations the successful management of their area's performance goals. Some FDA Centers link performance evaluations for managers to HHS-wide goals and the President's management Agenda.

Are all funds (Federal and partners') obligated in a timely manner and spent for the intended purpose?

Explanation: Funds are obligated in a timely manner, and spent for the intended purpose. FDA monitors spending centrally and at each program Center to ensure that funds are obligated for intended purposes.

Evidence: In addition to the budget execution monitoring by the central FDA budget office, each Center has their own internal budget formulation and execution processes to ensure that funds are obligated for their intended purposes in a timely manner.

Does the program have procedures (e.g., competitive sourcing/cost comparisons, IT improvements, approporaite incentives) to measure and achieve efficiencies and cost effectiveness in program execution?

Explanation: FDA has initiated an aggressive campaign to place many positions up for competitive sourcing. FDA has also stepped up efforts to use information technology to improve core agency functions, such as the review of new products, and the inspection of imported goods as they cross the border.

Evidence: The FDA Performance Plan for FY 2004 included annual performance goals measuring the use of IT in the review of new drugs and biologics, which dramatically streamlines the review process. The FY 2005 Performance Plan will introduce new agency-wide performance goals focused on management, including the competitive sourcing of 7.5% of non-governmental FTEs across the agency.

Does the program collaborate and coordinate effectively with related programs?

Explanation: FDA maintains strong working relationships with partner agencies such as the US Department of Agriculture, the Centers for Disease Control, and the National Institutes of Health. FDA conducts many collaborative projects with these agencies.

Evidence: FDA partners with: USDA and CDC on food safety; AHRQ on patient safety; NIH on the Pest Pharmaceuticals for Children Act, drug development. FDA also collaborates with other governments on International Harmonization of product standards through the International Conference on Harmonization.

Does the program use strong financial management practices?

Explanation: FDA has held a clean audit FDA has received clean audit opinions free of internal material control weaknesses for the past five years during audits completed by the HHS Office of the Inspector General.

Evidence: The FDA CFO Annual Report for FY 2002 provides a clean audit opinion free of internal material control weaknesses for FDA, and can be found on the FDA Internet site at: www.fda.gov/oc/oms/ofm/accounting/ofmaccounting.htm

Has the program taken meaningful steps to address its management deficiencies?

Explanation: FDA takes a systematic approach to identifying management weaknesses, and making improvements if necessary. Under the Federal Manager's Financial Integrity Act (FMFIA), all managers must be involved in and assume responsibility for developing cost-effective management, assessing the adequacy of management controls, identifying improvements, and reporting annually on management improvements. Each FDA Center conducts internal compliance reviews and certifies compliance to the Center director. FDA is also involved in the Partnership for Administrative Quality, which is an annual audit to determine if proper controls exist to ensure the integrity of administrative programs. This review covers seven areas, including financial management, personnel, procurement, and property management.

Evidence: Detailed information on FDA's FMFIA activities can be found on the FDA website at: www.fda.gov/oc/reform/default.htm

Did the program seek and take into account the views of all affected parties (e.g., consumers; large and small businesses; State, local and tribal governments; beneficiaries; and the general public) when developing significant regulations?

Explanation: FDA does a good job of considering the views of consumers, regulated industry, and other stakeholders when developing regulations. The FDA regulatory development process ensures the consideration of the views of all interested parties. It is often very challenging to balance the views of such a wide range of interested parties.

Evidence: FDA conducts many stakeholder meetings every year to discuss the development of regulations with the public. FDA solicits views from stakeholders in draft regulations and guidances. FDA often makes changes (sometimes significant changes) to regulations and guidances based on the comments received from stakeholders. FDA explains the agency position on stakeholders views in final regulations.

Did the program prepare adequate regulatory impact analyses if required by Executive Order 12866, regulatory flexibility analyses if required by the Regulatory Flexibility Act and SBREFA, and cost-benefit analyses if required under the Unfunded Mandates Reform Act; and did those analyses comply with OMB guidelines?

Explanation: FDA conducts Regulatory Impact Analyses that comply with OMB guidelines. This data is often reviewed by external sources. FDA does report that in some instances, the decision to regulate is made in advance of the completion of an RIA.

Evidence: Example regulations: Hazard Analysis and Critical Control Point Systems for Fruit and Vegetable Juices (January, 2001), Safe Handling Statements and refrigeration of Shell Eggs (December 2000), Labeling Requirements for Over-the-Counter Drugs (March 1999).

Does the program systematically review its current regulations to ensure consistency among all regulations in accomplishing program goals?

Explanation: FDA is starting to take a more active role in reviewing current regulations. FDA is moving in the right direction to ensure that regulations on the books are consistent and still relevant. However, further progress would be helpful, and a regularly scheduled regulatory review would further support this answer.

Evidence: Withdrawal of Certain Proposed Rules and Other Proposed Actions (68 FR 19766, April 22, 2003); Draft Guidance for Industry on "Part 11, Electronic Records, Electronic Signatures -- Scope and Application;" Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide (68 FR 8775; February 25, 2003).

Are the regulations designed to achieve program goals, to the extent practicable, by maximizing the net benefits of its regulatory activity?

Explanation: Regulations are designed to achieve program goals. FDA makes every attempt to maximize net benefits when developing and promulgating regulations. It is not always possible to maximize net benefits among a variety of options, since the best public health outcome may not always maximize net benefits. However, net benefits are always positive. FDA does try to balance these competing goals (public health and net benefits) as much as possible.

Evidence: Example Regulations: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics (December 2000), Substances Prohibited from Use in Animal Food or Feed: Animal Proteins Prohibited in Ruminant Feed (June 1997).

Has the program demonstrated adequate progress in achieving its long-term outcome performance goals?

Explanation: While FDA has created a new set of ambitious, measurable long-term outcome goals for the FY 2005 Budget, they are too new to show progress in meeting those goals. In some cases, baseline data is not yet available.

Evidence: FDA does have systems in place to create and gather baseline data to measure the success of their newly created long-term outcome goals. In some cases, improvements have been made in recent years in areas relating to the long-term outcome goals that will support improvements over the next few years. For the actual long-term outcome goals, see the Measures tab.

Does the program (including program partners) achieve its annual performance goals?

Explanation: FDA does a good job meeting the annual goals included in its annual Performance Plan. Many of these goals are mandated by statute or are negotiated with industry. In some cases, goals are set lower than the statutory target due to competing priorities.

Evidence: See Measures tab for detail on the annual performance goals. The Measures tab has a sample of some of the key goals.

Does the program demonstrate improved efficiencies or cost effectiveness in achieving program performance goals each year?

Explanation: FDA has created new efficiency goals over the past several years that measure improved use of information technology in agency administrative processes, and in achieving management reforms such as competitive sourcing.

Evidence: In some cases, such as the review of generic drugs, improvements have been made in performance without new resources. FDA has already completed three sourcing competitions with positive results and cost savings. FDA efficiency should continue to improve with the new efficiency goals that FDA has implemented.

Does the performance of this program compare favorably to other programs, including government, private, etc., that have similar purpose and goals?

Explanation: FDA has a unique Federal role in regulating drugs, medical devices, and vaccines. While USDA does have a role in the regulation of food, the types of food that each agency has jurisdiction over are different. Therefore, this question does not apply to FDA.

Evidence:  

Do independent and quality evaluations of this program indicate that the program is effective and achieving results?

Explanation: FDA is evaluated by a variety of outside organizations with frequency. The findings are primarily positive, but do reveal some weaknesses, particularly in some food safety areas and in blood safety.

Evidence: GAO and HHS OIG reports are available on the Internet. Results of these evaluations are generally positive, but do reveal some shortcomings. FDA has been praised by GAO for halting the dissemination of misleading prescription drug advertising, and for spending up the review of new drugs. Many of the criticisms of FDA in these reports are related to areas where the evaluators believe that FDA's legislative or regulatory authorities are not as strong or clear as they could be.

Were programmatic goals (and benefits) achieved at the least incremental societal cost and did the program maximize net benefits?

Explanation: FDA rules may not always maximize net benefits, but the benefits are indeed always greater than the costs of regulations. FDA works to keep costs to consumers low (if costs to consumers exist at all), but at times, costs to regulated industry can high. FDA is beginning efforts to review existing regulations to determine if they are appropriate for efficient science-based risk management.

Evidence: FDA does not always select regulatory options that maximize net benefits. In some cases, the option that presents the optimal public health outcome does not maximize net benefits -- even though net benefits are still positive. FDA is planning to review some existing regulations (such as regulations on review processes for new products) to determine if more efficient review practices would improve agency performance, and improve net benefits.