At your request, we have assembled data on all new drug applications submitted to FDA in 1987-94 to answer three questions:
Has the timeliness of the review and approval process for new drugs changed in recent years? What factors distinguish NDAs that are approved relatively quickly from those that take longer to be approved? What distinguishes NDAs that are approved from those that are not? Additionally, as you asked, we obtained the most recently available data on how long it takes for drugs to be approved in the United Kingdom and compared them with approval times in the United States. Once FDA has accepted an NDA, it decides whether to approve the drug on the basis of the information in the application and any supplemental information FDA has requested. For example, table 4 shows that the number of months that passed before half of all submissions were approved declined from 58 months for NDAs submitted in 1987 to 33 months for 1992 submissions. The average time was 24 months. Approval. In FDA’s statistical reports, it starts the clock with the submission of an “accepted” NDA. Neither therapeutic priority nor the experience of the sponsor affected review time.
Why GAO Did This Study

Pursuant to a congressional request, GAO provided data on the Food and Drug Administration's (FDA) new drug application (NDA) process, focusing on: (1) whether the timeliness of the review and approval process for new drugs changed in recent years; (2) the factors that distinguish NDA that are approved quickly from those that take longer to approve; (3) what distinguishes NDA that are approved from those that are not; and (4) how FDA drug approval process compares with the approval process in the United Kingdom.

What GAO Found

GAO found that: (1) the average number of months for NDA to be approved by FDA decreased from 33 months in 1987 to 19 months in 1992; (2) the overall decrease in approval times was achieved through gradual reductions in the submission of all NDA from 1987 to 1992; (3) the priority FDA assigns to an NDA and the experience of its sponsor determine the timeliness and likelihood of the approval process; and (4) although comparable data is limited, the review times for FDA and its counterpart agency in the United Kingdom are similar.