Strategies to Manage Improper Payments: Learning From Public and Private Sector Organizations (Exposure Draft) (Superseded by GAO-02-69G) (open access)

Strategies to Manage Improper Payments: Learning From Public and Private Sector Organizations (Exposure Draft) (Superseded by GAO-02-69G)

Guidance issued by the General Accounting Office with an abstract that begins "This publication has been superseded by GAO-02-69G, Strategies to Manage Improper Payments: Learning From Public and Private Sector Organizations, October 2001. This executive guide is intended to identify effective practices and provide case illustrations and other information for federal agencies' consideration when developing strategies and planning and implementing actions to manage improper payments in their programs."
Date: May 1, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Flood Insurance: Emerging Opportunity to Better Measure Certain Results of the National Flood Insurance Program (open access)

Flood Insurance: Emerging Opportunity to Better Measure Certain Results of the National Flood Insurance Program

A statement of record issued by the General Accounting Office with an abstract that begins "This testimony discusses the preliminary results of GAO's ongoing review of the National Flood Insurance Program (NFIP), which is run by the Federal Emergency Management Administration's (FEMA) Federal Insurance Administration (FIA) and Mitigation Directorate, a major component of the federal government's efforts to provide flood assistance. This program creates standards to minimize flood losses. GAO found that FEMA has several performance goals to improve program results, including increasing the number of insurance policies in force. Although these goals provide valuable insight into the degree to which the program has reduced flood losses, they do not assess the degree to which the most vulnerable residents--those living in flood-prone areas--participate in the program. Capturing data on the number of uninsured and insured structures in flood-prone areas can provide FEMA with another indication of how well the program is penetrating those areas with the highest flood risks, whether the financial consequences of floods in these areas are increasing or decreasing, and where marketing efforts can better be targeted. However, before participation rates can be used to measure the program's success, better data are needed on the total number …
Date: May 15, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
District of Columbia: Compensation Simplification Contracting Requirements (open access)

District of Columbia: Compensation Simplification Contracting Requirements

Correspondence issued by the General Accounting Office with an abstract that begins "The District of Columbia Appropriations Act of 2001 provided $250,000 for a contract to study and develop a plan to simplify the compensation systems, schedules, and work rules for DC government employees. The act placed several conditions on the appropriation, one of which was that GAO review the proposed solicitation for the contract to ensure that it adequately addressed all of the elements stipulated in the act. Government officials initially told GAO that they planned to apply the $250,000 payment to existing contracts that were being used in the District's independent effort to reform its classification and compensation systems--and therefore would not carry out the conditions that Congress had set for receipt of the funds. More recently, however, the officials said that they no longer plan to use the funds because doing so would delay the District's reform effort."
Date: May 16, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Research and Development Funding: Reported Gap Between Data From Federal Agencies and Their R&D Performers Results From Noncomparable Data (open access)

Research and Development Funding: Reported Gap Between Data From Federal Agencies and Their R&D Performers Results From Noncomparable Data

Correspondence issued by the General Accounting Office with an abstract that begins "A January report by the National Science Foundation (NSF) identified a $5 billion gap between the amount of money that federal agencies reported as research and development (R&D) support and the amount of money that those who did the R&D work reported as spent in 1998. According to NSF, federal agencies earmarked about $72 billion for R&D support in 1998, while those who carried out the R&D reported spending about $67 billion. GAO found that this gap results primarily from annually comparing two separate and distinct types of financial data--federal obligations and performer expenditures--that are not comparable. In addition, R&D funding are collected on a yearly basis, but,in reporting, the period that defines a year can vary. Furthermore, agencies and performers do not always agree on what type of activities fall under the category of R&D. Because the gap results from comparing two dissimilar types of financial data, it does not necessarily reflect poor-quality data, nor does it reflect whether performers are receiving or spending all the federal R&D funds obligated to them. Thus, even if the data collection and reporting issues were addressed, a gap would still …
Date: May 9, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Internal Controls: C-17 Payment Procedures Can Be Improved (open access)

Internal Controls: C-17 Payment Procedures Can Be Improved

Correspondence issued by the General Accounting Office with an abstract that begins "The Federal Acquisition Streamlining Act of 1994 allows the use of performance-based payment (PBP) as an alternative to other forms of contract financing. According to the Department of Defense (DOD), the paying office processed about one million invoices for 363,000 major contracts. In fiscal year 1999, only 195 of these contracts contained performance-based provisions. These contracts are so few in number because they are a relatively new form of contracting within DOD. In November 2000, however, DOD indicated that performance-based financing will be military's preferred contract financing method for future fixed-price contracts. This report reviews the C-17 aircraft production program as a case study of the business processes used to make investment expenditures during the production phase of a major weapons system. GAO chose this contract because it is mature, stable, and is performance-based rather than cost-based. GAO found internal control weaknesses in the C-17 program affecting compliance with regulations, policies, and procedures over (1) establishing withhold amounts by the Air Force contracting officer for conditionally accepted items, (2) processing by the Administrative Contracting Officer for performance-based payment requests, (3) processing by the Administrative Contracting Officer of invoices …
Date: May 30, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Fiscal Year 2002 Budget Request for the Internal Revenue Service (open access)

Fiscal Year 2002 Budget Request for the Internal Revenue Service

Correspondence issued by the General Accounting Office with an abstract that begins "For fiscal year 2002, Congress has before it two separate budget requests for the Internal Revenue Service (IRS)--the traditional request prepared by the administration and a separate request prepared by the IRS Oversight Board. There are some significant differences between the two requests. The administration is requesting about $9.4 billion while the Board is requesting an additional $300 million. This correspondence addresses several questions related to (1) the differences between the two requests, (2) IRS' hiring plans for its Staffing Tax Administration for Balance and Equity initiative, (3) the productivity of IRS staff, and (4) business systems modernization."
Date: May 1, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Veterans Affairs: Subcommittee Questions Concerning the Department's Information Technology Program (open access)

Veterans Affairs: Subcommittee Questions Concerning the Department's Information Technology Program

Correspondence issued by the General Accounting Office with an abstract that begins "The Department of Veterans Affairs' (VA) information technology (IT) program faces many challenges, including filling its chief information officer position, improving computer security, and refining its process for selecting, controlling, and evaluating its information technology investments. This correspondence answers several questions from Congress on these and other challenges facing VA's IT program."
Date: May 2, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Status of GAO's Recommendations to the Department of Housing and Urban Development (open access)

Status of GAO's Recommendations to the Department of Housing and Urban Development

Correspondence issued by the General Accounting Office with an abstract that begins "GAO's January 2001 Performance and Accountability Series provides an overview of management issues at the Department of Housing and Urban Development (HUD). In the series, GAO made several recommendations to improve HUD's programs and operations. This report reviews the status of nine key recommendations. GAO found that HUD has taken important steps toward addressing some of its management deficiencies; however, significant weaknesses persist in some major areas, including single-family mortgage insurance, rental housing assistance, information and financial management systems, and human capital."
Date: May 11, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Financial Management: Emergency Steel Loan Guarantee Program (open access)

Financial Management: Emergency Steel Loan Guarantee Program

Correspondence issued by the General Accounting Office with an abstract that begins "This report discusses the Emergency Steel Loan Program, which provides loan guarantees to qualified steel producing companies. GAO found that there has been only one guaranteed loan disbursed by a private lender for $110 million. With an 85 percent guarantee, the federal government's potential loss is $93.5 million, assuming no repayments and no recovery from property pledged as collateral. The financial condition of program applicants is not strong, and repayments of loans depend upon many future factors. Economic analysis indicates a flat demand for steel, moderate prices, and static imports of foreign steel forecasted for 2002 and 2003. Because of the low loan amount, the program has had a minimal overall effect on the U.S. steel industry through March 2001."
Date: May 25, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
VA Health Care: Community-Based Clinics Improve Primary Care Access (open access)

VA Health Care: Community-Based Clinics Improve Primary Care Access

A statement of record issued by the General Accounting Office with an abstract that begins "This testimony discusses the Veterans Health Administration's (VHA) efforts to improve veterans' access to health care through its Community-Based Outpatient Clinics Initiative. Overall, through its clinics, VHA is steadily making primary care more available within reasonable proximity of patients who have used VHA's system in the past. However, the uneven distribution of patients living more than 30 miles from a VHA primary care facility suggests that access inequities across networks may exist. Also, the improvements likely to result from VHA's planned clinics indicate that achieving equity of access may be difficult. In addition, GAO's assessment suggests that new clinics may have contributed to, but are not primarily responsible for, the marked rise in the number of higher-income patients who have sought health care through VHA in recent years. Although the clinics have undoubtedly attracted some new patients to VHA, GAO's analysis suggests that new patients would have sought care at other VHA facilities in the absence of the clinics. Enhanced benefits and access improvements afforded by eligibility reform may have attracted more new patients, including those with higher incomes."
Date: May 2, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Private Health Insurance: Federal Role in Enforcing New Standards Continues to Evolve (open access)

Private Health Insurance: Federal Role in Enforcing New Standards Continues to Evolve

Correspondence issued by the General Accounting Office with an abstract that begins "In recent years, Congress passed the Health Insurance Portability and Accountability Act (HIPAA) and three subsequent laws that create new federal standards for private health insurance which covers nearly 175 million Americans under the age of 65. These laws include standards guaranteeing access to health insurance for small employers and individuals with existing health conditions as well as requirements for health plans regarding mental health services, hospital care for mothers and newborns following childbirth, and reconstructive surgery following a mastectomy. Since HIPAA's enactment in 1996, federal agencies' enforcement roles have continued to evolve as they have established new or expanded existing enforcement activities to ensure compliance with standards under HIPAA and the related federal laws. Agency officials state that they have enough staff resources and expertise to carry out their current enforcement responsibilities. The Health Care Financing Administration's future role depends on the actions of states in enforcing the federal standards, as well as on congressional decisions about whether to reauthorize the Mental Health Parity Act or to enact additional patient protection legislation. In addition, the scope of the Department of Labor's future enforcement activities may depend on …
Date: May 7, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Defense Acquisitions: Navy and Marine Corps Pilot Program Initiatives to Reduce Total Ownership Costs (open access)

Defense Acquisitions: Navy and Marine Corps Pilot Program Initiatives to Reduce Total Ownership Costs

Correspondence issued by the General Accounting Office with an abstract that begins "This is the third in a series of GAO reports evaluating the military services' efforts to reduce weapons systems operating and support costs. GAO previously reported on Army and Air Force efforts. This report evaluates the Navy and Marine Corps pilot programs. GAO found that the Navy and Marine Corps have begun several efforts to reduce weapon system operating and support costs. For example, they are using an open architecture design method that reduces the cost of component replacement and changes later in system life. In addition, the Navy has other related objectives and initiatives that could significantly reduce operating and support costs. Through these and other initiatives, the Navy and Marine Corps have reported progress in reducing operating and support cost in its pilot programs."
Date: May 22, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
SEC's Report Provides Useful Information On Mutual Fund Fees And Recommends Improved Fee Disclosure (open access)

SEC's Report Provides Useful Information On Mutual Fund Fees And Recommends Improved Fee Disclosure

Correspondence issued by the General Accounting Office with an abstract that begins "This correspondence (1) discusses the Securities and Exchange Commission's (SEC) report on mutual fund fee disclosures and (2) reviews SEC's response to GAO's recommendations on improving fee disclosure. The results of SEC staff's comprehensive analyses and other findings generally corroborate the findings of GAO's report and provide considerable additional information on the trend in mutual fund fees. The SEC staff's report also contains several recommendations to the agency's Commissioners, and the Commission has already approved recommendations on after-tax return disclosure and fund governance. In response to GAO's recommendation that mutual fund investors' quarterly account statements disclose the specific dollar amount of fees they paid, SEC staff recommends that investors receive additional fee information in funds' annual and semiannual reports. The SEC staff's proposal would provide investors with more information on fees in a form that allows comparison among funds. However, it will not provide information specific to each investor, nor will it be provided in the most frequent and relevant source--the quarterly statement. Therefore, it may be less likely to increase investor awareness and spur additional price competition among mutual funds to the same degree as GAO's recommendation …
Date: May 3, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
U.S. Locations Where Beryllium Was Used or Detected (open access)

U.S. Locations Where Beryllium Was Used or Detected

Correspondence issued by the General Accounting Office with an abstract that begins "This report identifies U.S. locations where beryllium was used in workplace processes or detected as present in the workplace. Data show that beryllium was used or detected at locations in 45 of 50 states, plus the District of Columbia. However, the number of locations varied by state. For example, 30 states and the District of Columbia were reported as having from one to 10 locations, while 15 states were reported as having from 11 to 41 locations. The states without reported beryllium use were Alaska, Delaware, Minnesota, Vermont, and Wyoming."
Date: May 25, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
DOD Financial Management: Integrated Approach, Accountability, and Incentives Are Keys to Effective Reform (open access)

DOD Financial Management: Integrated Approach, Accountability, and Incentives Are Keys to Effective Reform

Testimony issued by the General Accounting Office with an abstract that begins "The results of the Defense Department (DOD) financial audit for fiscal year 2000 highlight long-standing financial management weaknesses that continue to plague the military. These weaknesses not only hamper the department's ability to produce timely and accurate financial management information but also unnecessarily increase the cost of carrying out its missions. Although DOD has made incremental improvement, it has a long way to go to overcome its long-standing, serious financial management weaknesses as part of a comprehensive, integrated reform of the department's business support operations. Such an overhaul must include not only DOD's financial management and other management challenges but also its high-risk areas of information technology and human capital management. Personnel throughout the department must share the common goal of reforming the department's business support structure. Without reengineering, DOD will have little chance of radically improving its cumbersome and bureaucratic processes."
Date: May 8, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Contract Management: Purchase of Army Black Berets (open access)

Contract Management: Purchase of Army Black Berets

Testimony issued by the General Accounting Office with an abstract that begins "The Army's decision to issue black berets to all of its forces in just eight months placed enormous demands on the military's procurement system. To meet this challenge, the Department of Defense (DOD) increased the domestic supplier's production, awarded contracts to known foreign sources, and procured berets from additional sources. This testimony discusses DOD's contracting strategy, including (1) the contracting procedures DOD used to buy the berets and (2) the circumstances surrounding waivers to the Berry Amendment, a statutory requirement to buy clothing from domestic suppliers. The Defense Logistics Agency (DLA) took several steps to expedite award of the contracts. However, DLA failed to (1) provide for full and open competition as required by the Competition in Contracting Act of 1984 or (2) obtain a review of these contract actions from the Small and Disadvantaged Business Utilization Office for possible small business participation. GAO also found that authority to waive the Berry Amendment was delegated to DLA's Director and Senior Procurement Executive by the Principal Deputy Under Secretary of Defense (Acquisition, Technology, and Logistics), but later canceled to ensure that any request for a waiver to the Berry …
Date: May 2, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
IRS Modernization: Continued Improvement in Management Capability Needed to Support Long-Term Transformation (open access)

IRS Modernization: Continued Improvement in Management Capability Needed to Support Long-Term Transformation

Testimony issued by the General Accounting Office with an abstract that begins "This testimony discusses (1) how well the Internal Revenue Service (IRS) is providing service to taxpayers and ensuring compliance with tax laws, and (2) IRS' progress in its long-term effort to modernize. GAO found that IRS posted mixed results in 2001 in collecting revenues, providing taxpayer service, and enforcing tax laws. On the plus side, IRS processed millions of tax returns and issued refunds without significant problems, taxpayers had an easier time getting through to telephone assistors, and IRS said that it made progress in correcting weaknesses that threatened the security of electronically filed tax information. On the down side, the quality of service provided to taxpayers who visited taxpayer assistance centers, trends in audit rates and enforcement programs, and productivity all experienced troubling declines. With respect to modernization, IRS is making incremental progress in overhauling its organization, performance management system, business processes, and information technology. IRS is also making important progress in implementing its new organizational structure, developing a blueprint for modernizing its business processes and information systems, and more fully defining its strategic direction. However, IRS progress has fallen short of expectations. For example, IRS is …
Date: May 8, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Developing Countries: Challenges Confronting Debt Relief and IMF Lending to Poor Countries (open access)

Developing Countries: Challenges Confronting Debt Relief and IMF Lending to Poor Countries

Testimony issued by the General Accounting Office with an abstract that begins "The Heavily Indebted Poor Countries (HIPC) Initiative and the International Monetary Fund's concessional (below-market terms) lending facility--the Poverty Reduction and Growth Facility--are two multilateral programs intended to help spur economic growth and reduce poverty in low-income countries, most notably countries in sub-Saharan Africa. The HIPC Initiative represents a step forward in the international community's efforts to relieve poor countries of their heavy debt burdens. It does so by seeking to include all creditors and by providing significant debt relief to recipient countries. Unless strong, sustained economic growth is achieved, however the initiative will not likely provide recipient countries with a lasting exit from their debt problems. Furthermore, as long as the initiative links debt relief to poverty reduction strategies, the tension between quick debt relief and comprehensive country-owned strategies is likely to persist. These issues should not be seen, however, as a reason to abandon efforts to provide debt relief to eligible countries. Heavily indebted poor countries continue to carry unsustainable debt burdens that are unlikely to be lessened without debt relief, but participants and observers need to be more realistic about what the initiative may ultimately achieve. …
Date: May 15, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Contract Management: Trends and Challenges in Acquiring Services (open access)

Contract Management: Trends and Challenges in Acquiring Services

Testimony issued by the General Accounting Office with an abstract that begins "Federal agencies spend billions of tax dollars each year to buy services--from clerical support to information technology assistance to the management of national laboratories. The federal government spent more than $87 billion in services--a 24 percent increase in real terms from fiscal year 1990. Some service procurements are not being done efficiently, putting taxpayer dollars at risk. In particular, agencies are not clearly defining their requirements, fully considering alternative solutions, performing vigorous price analyses, and adequately overseeing contractor performance. This testimony (1) describes service contracting trends and the changing acquisition environment, (2) discusses the challenges confronting the government in acquiring services, and (3) highlights some efforts underway to address these challenges. GAO found that purchases of services now account for about 43 percent of federal contracting expenses--the largest single spending category. The growth of services has been driven largely by the government's increased purchases of information technology services and professional, administrative, and management support services. Poor contract management has undermined the government's ability to obtain good value for the money and continues to be a major problem for the two biggest service purchasers-the Departments of Defense and Energy. …
Date: May 22, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Social Security Administration: Systems Support Could Improve Processing Attorney Fee Payments in the Disability Program (open access)

Social Security Administration: Systems Support Could Improve Processing Attorney Fee Payments in the Disability Program

Testimony issued by the General Accounting Office with an abstract that begins "To ensure that people claiming disability insurance program benefits can obtain legal representation at a fair price, the Social Security Administration (SSA) is required to regulate the fees that attorneys charge people to represent their disability claims before the agency. Balancing the needs of the claimants with those of their attorneys, the law limits the amount of fees that attorneys can charge claimants, but also guarantees that those fees will be paid from the claimants' past-due benefits. Inefficiencies in the current process increase both the time it takes to pay the attorney fees and the cost of administration. One segment of attorney fee processing--the fee approval process--was substantially simplified in 1991. Systems support could streamline the second segment of the processing--the fee payment--thus lowering the annual administrative costs and cutting processing time. Automation of this final segment of the fee process could help improve customer service for both claimants and their attorneys."
Date: May 17, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
U.S. Postal Service: Financial Outlook and Transformation Challenges (open access)

U.S. Postal Service: Financial Outlook and Transformation Challenges

Testimony issued by the General Accounting Office with an abstract that begins "The U.S. Postal Service (USPS) faces major challenges that collectively call for a structural transformation if it is to remain viable in the 21st century. This testimony discusses USPS' current financial outlook, actions that USPS has taken or planned to take, and the transformation issues that will need to be addressed. GAO concludes that structural transformation is essential if USPS is to overcome its financial, operational, and human capital challenges. It is at a growing risk of being unable to continue providing universal postal service at reasonable rates while remaining self-supporting through postal revenues. Although USPS has announced steps to address its mounting problems, it lacks a comprehensive plan to address its various financial, operational, or human capital challenges. USPS needs to develop a transformation plan in conjunction with Congress and other stakeholders that would address the key transformation issues facing USPS."
Date: May 15, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Defense Health Care: Lessons Learned from TRICARE Contracts and Implications for the Future (open access)

Defense Health Care: Lessons Learned from TRICARE Contracts and Implications for the Future

Testimony issued by the General Accounting Office with an abstract that begins "This testimony discusses lessons learned from the Department of Defense's (DOD) TRICARE contracts and their implications for the future. TRICARE's successes and maturity reflect the ability of the DOD and its contractors to work within the current contract structure. However, it has not been easy, and there are important lessons from current contract shortcomings that need to be addressed in designing future TRICARE contracts. Most, including DOD, believe that the current contracts are too large, complex, and prescriptive in nature, limiting innovation and competition. Also, numerous adjustments to these contracts have created an unstable program, and program costs have been difficult to predict, contributing to annual funding shortfalls. Additionally, financial incentives, accountability, and data quality need to be strengthened to achieve greater efficiencies. To address these weaknesses, DOD redesigned its solicitation for the next round of TRICARE contracts; however, the initial issuance was withdrawn because of internal concerns and reservations about its costs and specifications. DOD is now reassessing how to structure the TRICARE contracts and is considering the views and recommendations of the Defense Medical Oversight Committee, a group formed to oversee TRICARE."
Date: May 17, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
D.C. Criminal Justice System: Better Coordination Needed Among Participating Agencies (open access)

D.C. Criminal Justice System: Better Coordination Needed Among Participating Agencies

Testimony issued by the General Accounting Office with an abstract that begins "Every criminal justice system faces coordination challenges. However, the unique structure and funding of the D.C. criminal justice system, in which federal and D.C. jurisdictional boundaries and dollars are blended, creates additional challenges. The Criminal Justice Coordinating Council (CJCC) has played a useful role in addressing such coordination challenges, especially in areas in which agencies perceived a common interest. However, CJCC's uncertain future could leave D.C. without benefit of an independent entity for coordinating the activities of its unique criminal justice system. Funding CJCC through any participating agency diminishes its stature as an independent entity in the eyes of several CJCC member agencies, reducing their willingness to participate. Without a requirement to report successes and areas of continuing discussion and disagreement to each agency's funding source, CJCC's activities, achievements, and areas of disagreement have generally been known only to its participating agencies. This has created little incentive to coordinate for the common good, and all too often agencies have simply "agreed to disagree" without taking action. Furthermore, without a meaningful role in cataloging multiagency initiatives, CJCC has been unable to ensure that criminal justice initiatives are coordinated among …
Date: May 11, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library
Pediatric Drug Research: Substantial Increase in Studies of Drugs for Children, But Some Challenges Remain (open access)

Pediatric Drug Research: Substantial Increase in Studies of Drugs for Children, But Some Challenges Remain

Testimony issued by the General Accounting Office with an abstract that begins "Children fall ill with many of the same diseases as adults and are often treated with the same drugs. However, only about 25 percent of drugs used today have been labeled for pediatric patients. The lack of pediatric testing and labeling can place children at risk of under- or overdosing, and the lack of age-appropriate formulations, such as liquids or chewable tablets, can result in improper administration of drugs. The pediatric exclusivity provision of the Food and Drug Administration Modernization Act of 1997 has successfully encouraged drug sponsors to generate needed information on how drugs work in children. A wide range of drugs are being studied in many therapeutic areas. The infrastructure for conducting pediatric trials has also been greatly strengthened, which should help to support continued progress. Although several drug labels have been changed to incorporate findings from research done under the pediatric exclusivity provision, label changes typically occur long after the Food and Drug Administration has granted the extension of market exclusivity. In addition, there continues to be little incentive to conduct pediatric research on off-patent drugs."
Date: May 8, 2001
Creator: United States. General Accounting Office.
System: The UNT Digital Library