FDA’s medical  product responsibilities include oversight of the safety and effectiveness  of medical products marketed for sale in the United States, regardless of  whether they are manufactured domestically or overseas. FDA’s Medical Product Oversight Responsibilities

As part of its oversight responsibilities, FDA reviews applications  submitted by manufacturers for medical products they wish to market in  the United States to ensure that new products are safe and effective,  inspects establishments producing medical products to ensure  manufacturing processes meet quality standards, reviews reports of  adverse events to monitor the safety of marketed medical products, and  examines advertising and other promotional materials to ensure they are  not false and misleading. Driven by User Fees, Funding and Staffing for Medical Product Programs Have Increased, Although FDA Is Concerned about Staffing Levels

Funding and staffing for FDA’s medical product programs have increased  mostly as a result of user fee funding, which is primarily directed toward  the agency’s review of new medical products. Medical product program funding increased 112 percent overall, from  about $562 million in fiscal year 1999 to about $1.2 billion in fiscal year  2008. Although total funding increased, FDA officials reported that the decline in  the portion of funding available to activities not funded by user fees has  seriously limited the agency’s ability to fulfill its oversight responsibilities  in some areas. FDA Faced Challenges Fulfilling and Managing Its Growing Medical Product Oversight Responsibilities, Citing Resource Constraints

New laws and a growing workload increased FDA’s medical product  oversight responsibilities. However, agency officials said  that this training results in less time available for staff to perform their  routine duties. FDA Officials Cited Resource Constraints as Hindering the Agency’s Ability to Fulfill Its Oversight Responsibilities in Some Areas between Fiscal Years 2004 and 2008

FDA officials told us that resource constraints hindered the agency’s  ability to fulfill all of its medical product oversight responsibilities  between fiscal years 2004 and 2008, but the agency also lacked information  to manage some of these oversight responsibilities and estimate current  and future resource needs. FDA  officials also told us that the funding amounts requested for FDA and  provided by Congress during the past 2 years will permit the agency to  respond to its most urgent needs and priorities, although officials also  noted that they did not receive enough resources to meet some statutory  requirements. Furthermore, FDA officials also noted that the  agency continues to face significant challenges fulfilling its mission. FDA could  not provide data showing its workload and accomplishments in some  areas. Appendix I: Funding and Staffing Resources for FDA Medical Product Programs, Fiscal Years 1999 through 2008

Funding resources for the Food and Drug Administration’s (FDA) medical  product programs increased 112 percent between fiscal years 1999 and  2008. Over the same period, funding  resources for FDA’s process for reviewing NDAs and BLAs, an activity that  receives both user fee funding and fiscal year appropriations, increased   58 percent. Drugs. However,  FDA could not provide data on the number of draft or final materials staff  examined during this time. Biologics. Devices.
Why GAO Did This Study

Twenty years ago, GAO reported that the Food and Drug Administration (FDA) was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products--human drugs, biologics, and medical devices--marketed for sale in the United States. Since then, FDA, GAO, and others have raised concerns regarding FDA's ability to meet its oversight responsibilities. GAO was asked to review the resources supporting FDA's medical product oversight responsibilities. GAO examined trends in (1) FDA's funding and staffing resources for its medical product oversight responsibilities from fiscal years 1999 through 2008, and (2) FDA's medical product oversight responsibilities during this same period. GAO analyzed FDA data on the agency's resources and workload, reviewed relevant federal laws, and interviewed FDA officials. GAO also examined more-detailed data on FDA's fiscal year 2004 through 2008 resources and workload in four key areas, representing a range of FDA's oversight responsibilities, both before and after a medical product is marketed in the United States.

What GAO Found

Funding and staffing resources for FDA's medical product programs increased between fiscal years 1999 and 2008, primarily as a result of increased user fees paid by industry, which are made available through appropriations acts to support the agency's processes for reviewing new medical products. Total funding increased from about $562 million in fiscal year 1999 to about $1.2 billion in fiscal year 2008, with user fee funding accounting for more than half of this increase. A large and growing portion of funding supported activities for which user fees are collected, resulting in a declining share of funding available for other activities. FDA officials said that this has seriously limited the agency's ability to fulfill its oversight responsibilities in some areas, particularly those not funded with user fees. FDA faced challenges fulfilling and managing its growing medical product oversight responsibilities, which agency officials attributed to resource constraints. FDA's statutory responsibilities grew during this period and a growing number of medical products subject to FDA oversight and establishments manufacturing these products for the U.S. market also added to the agency's workload. However, FDA could not provide data showing its workload and accomplishments in some areas, such as its review of reports identifying potential safety issues with specific medical products. Without such information, FDA cannot develop complete and reliable estimates of its resource needs. While FDA officials said that the funding amounts requested for and provided to FDA during the past 2 years will permit the agency to respond to its most urgent needs and priorities, officials also noted that they did not receive enough resources to meet some statutory requirements, such as biennially inspecting certain manufacturing establishments. Furthermore, officials said that the agency faces significant challenges fulfilling its mission to oversee the safety and effectiveness of medical products.