FDA’s Drug and Biologic Review Process

In addition to ensuring that new drugs and biologics are safe and effective  and that applications for their approval are reviewed timely, FDA is also  responsible for monitoring drugs and biologics for continued safety after  they are in use. Once the center has accepted the application, it designates the product as  either “priority,” for products that would provide significant therapeutic  gains compared to any existing products on the market, or “standard,” for  products that would provide no significant therapeutic advantage over  other drugs already on the market. In fiscal year 2002,  FDA expects to obligate about $170 million in user fees, or 51 percent of  the $332 million that FDA expects to spend on its drug and biologic review  processes. 5). PDUFA Has Contributed to Increased Workload and Attrition and Decreased Training for FDA Reviewers

FDA officials told us that the performance goals added by PDUFA II,  combined with PDUFA II’s shortened review timelines, have contributed  to a heavy workload for FDA’s reviewers, which has resulted in high  turnover and reviewers forgoing training and professional development  activities. PDUFA II Resulted in Increased Reviewer Workload

PDUFA II affected reviewer workload by shortening review times and  adding new performance goals to reduce overall drug development time— the time needed to take a drug from clinical testing to submission of a new  drug or biologic application. The availability of new, safer treatments also led to some  withdrawals. Size of the Increase in Drug Withdrawal Rates Differs Depending on the Period Examined

Our analysis of FDA data found that a higher percentage of drugs has been  withdrawn from the market for safety-related reasons since PDUFA’s  enactment than prior to the law’s enactment. Fewer resources for non-PDUFA programs may affect  FDA’s ability to ensure that the other products the agency regulates, such  as food and medical devices, comply with FDA safety standards. Rapid FDA approval of new drugs means that the United States has  become the first nation to approve many new medicines. The recent increase in the rate of drug  withdrawals also suggests the need for FDA to strengthen its postmarket  surveillance activities.
Why GAO Did This Study

Ten years ago, Congress passed the Prescription Drug User Fee Act to speed up the review process used to ensure that new drugs and biological products are safe and effective.

What GAO Found

GAO found that the act has provided the Food and Drug Administration (FDA) with the funding needed to hire more drug reviewers, which has led to faster availability of new drugs to the United States. Approval times have shortened both for priority drugs--those that FDA expects to offer significant therapeutic benefits beyond drugs already on the market--and standard drugs, which are not thought to have significant therapeutic benefits beyond available drugs. Although the act has increased the funds available for FDA's drug and biological reviews, funds for other activities, such as the regulation of foods and medical devices, have shrunk as a share of FDA's overall budget. The 1997 amendments to the act, which shortened review schedules and set new performance goals to reduce overall drug development time, have increased reviewer workload at FDA. GAO found that some drug reviewers may have forgone training and professional development opportunities to ensure that the new goals were met. FDA officials said that the agency continues to experience high turnover rates among these employees. GAO found that a higher percentage of drugs has been withdrawn from the market for safety reasons since the act was enacted but the that the size of the increase in withdrawal rates differs depending on the period examined. The higher rate of drug withdrawals suggests that FDA needs to strengthen its postmarket surveillance efforts. FDA plans to spend $71 million in user fees during the next 5 years to improve the monitoring of new drugs on the market and to track any harmful effects of these products.