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U.S. Department of Health and Human Services

Safety

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Legislative And Management Initiatives Have Helped Speed Review Time

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : Introduction

To address concerns about the timeliness of reviews, the pharmaceutical industry, consumer groups, FDA, and Congress worked together to develop new legislation. Through the Prescription Drug User Fee Act of 1992 (PDUFA) and the Modernization Act of 1997, Congress has encouraged the FDA to act more rapidly in making decisions on whether new medical products may enter the marketplace. PDUFA provides FDA with additional funds from user fees, permitting FDA to employ a larger workforce to handle review workloads. The fees are paid by the sponsors of new drug and biological products and can only be used in support of the new pharmaceutical product review process. PDUFA did not change FDA's standard for drug and biologics safety and effectiveness.

These legislative initiatives have been successful. Since its enactment, PDUFA user fees have paid for a 60-percent increase in staff assigned to the review of new pharmaceutical applications. The average time from submission of an application to approval has dropped from about 30 to 12 months. Along with this improvement in review times has come an increase of almost 40 percent in the number of new products approved per year, from an average of 70 to 97 applications per year. Industry negotiated strict administrative accountability and aggressive review time performance goals in exchange for its support of PDUFA. FDA has established an excellent record of meeting, or exceeding, these goals. FDA's faster review is not just the result of more FDA staff, but is also due to improvements in program management and efforts to streamline the review process.

Unlike the Center for Drugs and the Center for Biologics, the Center for Devices did not benefit from user fees. However, the medical device program received a budget increase in 1994. This increase, along with a reallocation of funds from other activities, management changes, and program reengineering improved results for the device program. For example, the review time for device premarket applications (PMAs) has decreased from 27 months in 1994 to 12 months in 1998.

Next Section : Concerns have been raised about the Effects of PDUFA