Performance Improvement 1998. Food and Drug Administration

02/01/1998

Contents

Report of the Prescription Drug User Fee Act (PDUFA) of 1992-Fiscal Year 1997 Report to Congress

Economic Impact Analysis of Regulations Under the Mammography Quality Standards Act of 1992

Mammography Quality Standards Act: Second Annual Government Entity Declaration Program Audit

Product Review Performance Report

Evaluation of Device Performance in the Determination of Substantial Equivalence

Cost of Restrictions on Gulf Oyster Harvesting for Control of Vibrio vulnificus-Caused Disease

Health Transfers: An Application of Health-Health Analysis to Assess Food Safety Regulation

Preliminary Investigation into the Morbidity and Mortality Associated with the Consumption of Fruit and Vegetable Juices

TITLE: Report of the Prescription Drug User Fee Act (PDUFA) of 1992-Fiscal Year 1997 Report to Congress

ABSTRACT: Fiscal year 1997 (FY 97) marks the fifth and final year of the implementation of the Prescription Drug User Fee Act (PDUFA) of 1992, which authorizes the collection of fees from the pharmaceutical industry in order to facilitate the Food and Drug Administration's (FDA's) timely review of human drug applications. The Act mandates that FDA prepare yearly reports for each fiscal year for which fees are collected. The fifth annual report, prepared in response to that mandate, covers FY 97 and reports on how well the FDA has accomplished the performance goals it established for FY 97. These performance-related goals were jointly established by the FDA and the pharmaceutical industry and fall into three main categories: (1) elimination of overdue backlogs, (2) building excellence into the review process, and (3) achievement of high performance. Seven goals were in effect for FY 97. The findings in the report show that the successes reported last year have been confirmed and surpassed. The report finds that (1) PDUFA has resulted in more and better applications filed, which can be accepted immediately and reviewed and approved more quickly; (2) nearly all applications now go directly into the review process (due to the increased quality of the applications, very few are refused); (3) there are more approvals on first review, which demonstrates that submission quality is a key factor in achieving timely reviews; and (4) the ultimate approval time for applications in the PDUFA years has dramatically decreased. While only a preliminary performance assessment of FY 97 is possible at this time, it is clear that the Act's stringent review goals have assured that new pharmaceutical products are getting onto the market at an unprecedented rate without compromising safety. See also PIC ID Nos. 6079 and 6079.1. (Final report: 10 pages, plus appendices.)

AGENCY SPONSOR: Office of Planning and Evaluation

FEDERAL CONTACT: Dennis Hill

PHONE NUMBER: (301) 827-5255

PIC ID: 6079.2

PERFORMER ORGANIZATION: Office of Planning & Evaluation, Food and Drug Administration, Washington, DC

TITLE: Economic Impact Analysis of Regulations Under the Mammography Quality Standards Act of 1992

ABSTRACT: The Food and Drug Administration (FDA) is charged with ensuring that accessibility to quality mammography services is maintained for all facilities performing mammographies in accordance with the Mammography Quality Standards Act of 1992 (MQSA). Under this statute, the FDA is required to certify and annually inspect over 10,000 mammography facilities. Prior to the passage of the MQSA, FDA's oversight responsibility was limited to approving new mammographic processors, x-rays, and tubing. However, MQSA requires that facilities within its jurisdiction meet standards developed by the agency to ensure a reasonable level of quality in order to achieve certification by the agency. FDA is concerned that recent trends by third-party payers to attract payments for mammography services have severely limited the ability of facilities to absorb any cost increases caused by the quality standards. These cost increases, as well as excess capacity, may cause low-volume facilities to leave the industry. This project addresses these problems in two ways. First, it measures the effect of standards on patient access to mammography, especially in rural areas; second, it develops a cost model that will be used to predict the impact of proposed standards on the costs of providing mammography. The contractor reviewed records from over 10,000 facilities that had applied for accreditation and over 500 that had ceased operations. In the Spring of 1996, the contractor drafted the results of a cost-benefit analysis, which FDA managers will use to develop a performance-oriented regulatory policy that will be coordinated with existing customers.

AGENCY SPONSOR: Office of Planning and Evaluation

FEDERAL CONTACT: Steve Tucker

PHONE NUMBER: (301) 827-5340

PIC ID: 6080

PERFORMER ORGANIZATION: Eastern Research Group, Incorporated, Arlington, VA

TITLE: Mammography Quality Standards Act: Second Annual Government Entity Declaration Program Audit

ABSTRACT: The Food and Drug Administration's (FDA's) Division of Mammography Quality and Radiation Programs requested that the Division of Planning, Analysis, and Finance conduct an audit of the Mammography Quality Standards Act (MQSA) Government Entity (GE) Declaration Program. There are two main goals of the audit: (1) to notify facilities that they will be held accountable for their self-certification of fee exemption, and (2) to determine the rate of compliance with the program. A random sample of 90 facilities out of the 989 claiming GE status was selected for examination, and a random sample of 20 (out of 72) new GE facilities was also examined. The audit revealed that (1) only 3 of the 90 GE facilities had claimed GE status incorrectly, and only 1 of the 20 new GE facilities had claimed incorrect status; and (2) the 3 GE facilities (as well as the one new GE facility) that did not meet FDA's fee-exempt status claimed that exemption based on funding from the Centers for Disease Control and Prevention (CDC) Breast and Cervical Cancer Prevention Program, which is the least common way to claim fee exemption. Based on these results, the audit concludes that the GE Declaration program appears to be quite effective. It also suggests several recommendations based on the findings of the audit. These include that: (1) the results should be published to allow the impact of the audit to reach many, if not all, the facilities, to discourage any future misrepresentations, and to demonstrate that FDA will exercise its authority; (2) the sample size of future audits should be smaller and should contain a larger portion of those facilities claiming fee exemption based solely on funding from the CDC; and (3) the MQSA contractor in charge of billing should continue to thoroughly examine each GE Declaration form to ensure that it identifies the body operating the facility. (Final report: 3 pages, plus appendices.)

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Stephanie Wilkinson

PHONE NUMBER: (301) 594-1284

PIC ID: 6730

PERFORMER ORGANIZATION: Center for Devices and Radiological Health, Rockville, MD

TITLE: Product Review Performance Report

ABSTRACT: This is the first annual report analyzing the Food and Drug Administration's (FDA's) performance in reviewing applications for human drugs, biological products, medical devices, food and color additives, and veterinary drugs. In the past, FDA has measured the length of review using measures that varied for different product categories, making it difficult to provide an agency-wide assessment of the FDA's performance. Responding to legislation such as the Prescription Drug User Fee Act of 1992 (PDUFA), as well as to requirements under the Federal Food, Drug, and Cosmetic Act, the FDA has developed clear performance goals for reviewing new product applications. Setting these goals has provided a valuable management tool for identifying performance expectations and assessing achievements, and for meeting the requirements of the Government Performance and Results Act of 1993. FDA has also developed performance measures and reporting conventions that can be used to report on product review performance consistently across product categories. The report looks at four different measures of the FDA's performance: (1) how often FDA is meeting statutory and nonstatutory time frames for review of each category of products, (2) the median length of time to approval for each product category, (3) the total number of products approved in each category, and (4) the number of applications for which an action was overdue at the end of the fiscal year (FY). It provides FDA's on-time performance for FY 1993, 1994, and 1995 and performance data for the other three categories for FY 1993 to 1996. The report finds that (1) for most categories of products, FDA has improved its performance since FY 1993; (2) the greatest improvements in performance have occurred for product reviews covered by PDUFA; (3) significant progress has been made in reviewing applications for medical devices; and (4) on-time performance for reviews of non-PDUFA applications should be improved.

AGENCY SPONSOR: Office of Planning and Evaluation

FEDERAL CONTACT: Paul Coppinger

PHONE NUMBER: (301) 827-5292

PIC ID: 6731

PERFORMER ORGANIZATION: Food and Drug Administration, Rockville, MD

TITLE: Evaluation of Device Performance in the Determination of Substantial Equivalence

ABSTRACT: Many diagnostic medical devices that reach the market are based on diagnostic agreement with some device already on the market that targets the same attribute. Agreement is often assessed by side-by-side testing of the same subjects or specimens, even if the true disease status is unknown. If each new test is compared with the most recent predicate, what would be the effect on device performance over time? Would it deteriorate, remain the same, or improve? This analysis attempts to address these questions using statistical measures of sensitivity, specificity, and predictive values. A Monto Carlo simulation was used to study this question of "predicate (pre-Amendments or reclassified post-Amendments) creep." Contingency tables were randomly generated using a range of conditional probabilities and prevalence representing screening and confirmatory test data. When a new test was found to be equivalent to the current predicate, it became the new predicate. After 50 new predicates were found, a forecast procedure was applied to the sequence of 50 performance parameters in order to evaluate the long-term trend.

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: John Dawson

PHONE NUMBER: (301) 827-0201

PIC ID: 6734

PERFORMER ORGANIZATION: Center for Devices and Radiological Health, Rockville, MD

TITLE: Cost of Restrictions on Gulf Oyster Harvesting for Control of Vibrio vulnificus-Caused Disease

ABSTRACT: This study for the Food and Drug Administration (FDA) estimates the costs of a seasonal harvesting restriction on Gulf of Mexico oysters and a seasonal marketing restriction on the sale of Gulf oysters for raw consumption. These measures would control oyster-related illnesses in humans known to be caused by the bacterial species Vibrio vulnificus, which naturally occurs in estuarine waters and is a normal flora for oysters. During this study, the 1995 Interstate Shellfish Sanitation Conference (ISSC) adopted a Vibrio vulnificus interim control plan for oysters and the report compares the costs of complying with the ISSC plan with FDA's suggested alternatives. The ISSC interim control plan (1) states that oysters must be under ambient refrigeration at 45 degrees Fahrenheit within a specified time if they are harvested from State waters that were the confirmed source for two or more Vibrio vulnificus illnesses; (2) establishes action levels for growing areas within affected States; and (3) varies the time-to-refrigeration requirement according to the average monthly maximum water temperature. The report estimates the economic impact of alternative remedies for controlling Vibrio vulnificus-related illnesses and concludes that (1) the in-shell marketing restriction might have imposed large economic impacts on the Gulf oyster industry and other related sectors of the economy; (2) the ISSC time and temperature controls would have smaller aggregate economic impacts than the marketing restriction option but the distributional effects of this policy should be considered; and (3) the ISSC impacts are sensitive to specific assumptions about enforcement of the rule and types of responses, engendered by the regulated entities. (Final report: variously paginated.)

AGENCY SPONSOR: Center for Food Safety and Applied Nutrition

FEDERAL CONTACT: Richard Williams

PHONE NUMBER: (202) 205-5667

PIC ID: 6856

PERFORMER ORGANIZATION: Research Triangle Institute, Research Triangle Park, NC

TITLE: Health Transfers: An Application of Health-Health Analysis to Assess Food Safety Regulation

ABSTRACT: Public health policy decisions usually focus on reducing a target risk. However, complying with regulations to reduce a risk is expensive. Because income influences health, Health-Health Analysis (HHA) was developed to compare the targeted reduction in mortality to the induced mortality from income losses. This study applies HHA to assess a potential Gulf oyster harvesting ban to control mortality from the consumption of oysters contaminated by Vibrio vulnificus. The report estimates the induced deaths using Anderson et al.'s estimate of economic losses and Keeney's estimate of the functional relations between income and mortality. The report shows that while a 7-month Gulf oyster harvesting ban might eliminate the estimated 17 oyster-related deaths annually, it may also cause as many as 12 income-loss-related deaths. The induced deaths occur principally among white males and black females. The report concludes that (1) HHA may give decisionmakers reason to pause considering the high costs of a harvesting ban and that consumption of raw oysters is completely voluntary; and (2) this illustration shows that HHA serves as a useful policy analysis tool. (Final report: 26 pages.)

AGENCY SPONSOR: Center for Food Safety and Applied Nutrition

FEDERAL CONTACT: Richard Williams

PHONE NUMBER: (202) 205-5667

PIC ID: 6857

PERFORMER ORGANIZATION: Center for Food Safety and Applied Nutrition, Washington, DC

TITLE: Preliminary Investigation into the Morbidity and Mortality Associated with the Consumption of Fruit and Vegetable Juices

ABSTRACT: Americans consumed 2.3 billion gallons of the major fruit and vegetable juices in 1995. Recent outbreaks of illnesses associated with the consumption of juices demonstrate their potential as a human health hazard. As part of the cost-benefit analysis for both the Hazard Analysis and Critical Control Point (HACCP) and labeling rules associated with fruit and vegetable juices, the Center for Food Safety and Applied Nutrition's working group was asked to investigate the morbidity and mortality associated with human consumption of juice drinks. The standard procedure for estimating human health benefits is to (1) estimate the baseline numbers of illnesses and deaths associated with the compound to be controlled, (2) estimate the likely reductions in those illnesses and deaths associated with various proposed control options, and (3) estimate the values associated with the reduced illnesses and deaths. This report estimates the baseline numbers of illnesses and deaths likely to be associated with the consumption of juice products. The study (1) describes juice products, (2) estimates juice consumption, (3) discusses production methods, (4) explains how hazards might be introduced into juice, (5) discusses evidence on illness from consuming juices, (6) describes human health effects caused by selected microbial pathogens, and (7) discusses the physical and chemical hazards associated with juices. Juices accounted for 447 laboratory-confirmed cases of illness associated with microbial pathogens, according to Centers for Disease Control and Prevention outbreak data and U.S. Food and Drug Administration recall data from 1993 through 1996. The other hazards, mostly physical and chemical, that have been found in juices have been sporadic and associated with fewer cases than the microbial pathogens. (Final report: 65 pages, plus appendices.)

AGENCY SPONSOR: Center for Food Safety and Applied Nutrition

FEDERAL CONTACT: Richard Williams

PHONE NUMBER: (202) 205-5667

PIC ID: 6858

PERFORMER ORGANIZATION: Center for Food Safety and Applied Nutrition, Washington, DC

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