Table 3
Costs of Clinical Trials on Drugs Qualifying for Orphan Drug Tax Credit
 U.S. Orphan Drug Credit (`00 dollars)

Year Credit Approvals Expenditure $/approval
Nominal		 Expenditure $/approval
1995 dollars
1983 236 2 472 236 695 348
1984 105 3 210 70 297 99
1985 204 6 408 68 559 93
1986 6,530 5 13,060 2,612 17,447 3,489
1987 5,154 9 10,308 1,145 13,352 1,484
1988 8,053 8 16,106 2,013 20,117 2,515
1989 14,190 10 28,380 2,838 34,016 3,402
1990 15,637 12 31,274 2,606 35,953 2,996
1991 18,475 12 36,950 3,079 40,841 3,403
1992 17,826 13 35,652 2,742 38,353 2,950
1993 20,486 13 40,972 3,152 42,959 3,305
83-93 106,896 93 213,792 2,299 . 2,630
89-93 86,614 60 173,228 2,887 . 3,202

Source: January 13, 1997, "Call for More Reliable Costs Data on Clinical Trials," Marketletter. pages 24 and 25.

Table 4
DiMasi, et al's 1991 Estimates of the Costs of Drug Development
In 1998 dollars

. Out of pocket per approval Capital Costs at 5% Capital Costs at 9% Capital Costs at 15%
  Pre-Clinical 89:      57.9% 145:    63.3% 212:    67.5% 365:    72.7%
  Clinical 65:      42.1% 84:      36.7% 102:    32.5% 137:    27.3%
  Total 155:    100.0% 229    100.0% 313    100.0% 502    100.0%

Table 5
DiMasi et al 1991 estimates: out of pocket and capital costs compared
1998 dollars, 15 percent capital costs

. Out of pocket p/app Capital Cost @15% Total    .  Out of pocket p/app Capital Cost @15% Total  
Pre-clinical 89 276 365  .  18% 55% 73%
Clinical 65 72 137  .  13% 14% 27%
Total 155 347 502  .  31% 69% 100%

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