Table 2.

The relationship between adverse post-marketing safety outcomes and time to review goal date (1 week)

Post-marketing safety outcome	Drug withdrawn after approval due to safety concerns			Drug ever received a post-marketing boxed warning
Explanatory variables	Odds ratio	95% CI	p value	Odds ratio	95% CI	p value
Log (number individuals exposed to drug in clinical trials)	1.12	[0.35, 3.552]	0.85	1.24	[0.726, 2.127]	0.43
Review completed 1 week before last-cycle review goal date	0.26	[0.033, 2.098]	0.21	0.89	[0.323, 2.449]	0.82
Drug underwent the priority review designation	1.19	[0.116, 12.187]	0.88	3.51**	[1.02, 12.106]	0.05
Log (post-marketing volume sales in standardized units)	1.31	[0.796, 2.155]	0.29	1.22*	[0.961, 1.555]	0.10
Log (drug’s order of entry)	0.98	[0.159, 6.044]	0.99	0.96	[0.422, 2.197]	0.93
Log (manufacturer’s accumulated number of drug approvals)	2.82	[0.715, 11.113]	0.14	1.40	[0.82, 2.378]	0.22
Route of administration injectable	4.03	[0.192, 84.177]	0.37	0.43	[0.085, 2.16]	0.31
Drug approved with boxed warning	0.74	[0.04, 13.614]	0.84	3.88***	[1.32, 11.399]	0.01
Number of years the drug is commercially marketed	1.51**	[1.008, 2.265]	0.05	1.04	[0.892, 1.2]	0.65
N	219			219

^***Statistically significant at the p<0.01 level;

^**Statistically significant at the p<0.05 level;

^*Statistically significant at the p<0.10 level (all tests are two-tailed)