Auxiliary Web Page for FDA Drug Review Deadlines Study

Paper: D. Carpenter, E. J. Zucker, and J. Avorn. "Drug Review Deadlines and Safety Problems," New England Journal of Medicine 358 (13) (March 27, 2008) 28-35.

In-Depth Analysis: A paper that goes into the data in much greater detail is available here. Note that this paper is not yet published; corrections and comments are welcome.

Theoretical Stochastic Model: A mathematical model predicting the relationships observed in the paper is available here. Note that this paper is incomplete and not yet published; corrections and comments are welcome. Warning: The file is large due to multicolor figures from numerical simulations of the model.

Salient Examples: A number of people have asked for examples of drugs that were approved in the two-month window before the deadlines and later experienced post-marketing regulatory events. A partial list is available here.

Replication Data and Corrected Data

The original data, and line-by-line comparisons to alternative data posted by three FDA officials, appears here as an Excel spreadsheet, here as a MS Word doc, and here as an HTML document.

A comma-separated format [CSV] file with revised data, including our original measures and corrected measures, is available here.

An Excel spread sheet with revised data, including our original measures and corrected measures, is available here.

A codebook for the revised data is available here.

Response to Nardinelli: FDA officials Clark Nardinelli, Michael Lanthier and Robert Temple have written a letter to the NEJM in response to our study in which they dispute the accuracy of our data and our conclusions. A memorandum to the NEJM Editors, with detailed responses to the Nardinelli letter and with dozens of sensitivity analyses and replications, is available here.