The Prescription Drug User Fee Act (PDUFA) authorized FDA to collect fees from companies that produce human drug and biological products. The PDUFA annual performance report to Congress for FY 2000 focuses on the Agency's performance toward the agreed-upon numeric goals for reviewing and acting on submissions and responding to sponsors' pre-submission requests. The major accomplishments to report are: (1) FDA continued to exceed nearly all the review performance goals in FY 2000 increasing numbers of applications filed; higher quality applications; quicker approvals for products with the requisite data; and outcomes that result in more quality products reaching American practitioners and consumers faster; (2) application filings and quality remain high by historic standards and approval times continue to drop; (3) compared to the approval rates for all new drug applications, there is a smaller increase in approval rates for new molecular entities (NMEs), unique new drugs that are approved for the first time by FDA; (4) median total approval time (i.e., time from the initial submission of a marketing application to the issuance of an approval letter) for priority applications submitted in FY 99 was 6 months, less than half the median approval times for priority applications submitted in the early PDUFA years. The FDA performance report states that since the passage of PDUFA there has been a shift in the pattern of NME introductions with more American patients now receiving the benefits of important new drugs before they are available to citizens of other countries. This shift requires that FDA be increasingly vigilant in its post- market surveillance efforts.
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Dennis Hill, 301-827-5255
PIC ID: 6079.5
PERFORMER: Office of Planning, Policy Analysis and Legislation, Rockville MD