FDA Review and Approval Times

GAO discussed the Food and Drug Administration's (FDA) drug review and approval process, focusing on the timeliness of the review and approval process for new drugs and how that timeliness compares to that in the United Kingdom. GAO noted that: (1) FDA considerably reduced the time it takes to review new drug applications from an average of 33 months for applications submitted in 1987 to about 19 months for applications submitted in 1992; (2) FDA took even less time to review drugs that it determined to be a priority because of potential therapeutic benefit and for drug applications submitted by sponsors who had the most experience with the FDA approval process; (3) 44 percent of the drug applications submitted through 1992 were not approved because FDA did not find them to be safe and effective or the sponsors did not pursue their approval; (4) FDA met decision deadlines for new drug applications 67 percent of the time; and (5) the United Kingdom's process for reviewing new drugs takes about the same amount of time as the FDA process.