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U.S. Department of Health and Human Services

For Industry

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Long Descriptions: White Paper-Prescription User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications

 History of Funding for Review of Human Drugs

The total funding for human drug review in millions, has increased from $125.9 in FY 1992 entirely from appropriated funds, to $436.9 in FY 2004, $232.1 of that total obtained from user fees and only $204.8 from appropriated funds.  The total funding for human drug review in FY 1993 was $135.4, $8.9 from user fees and 135.4 from appropriated funds.  The total funding for drug review in FY 1994 was $169.2, $39.9 from user fees and $129.3 from appropriated funds.  The total funding for drug review in FY 1995 was $213.9, $74.1 from user fees, and $139.8 from appropriated funds.  The total funding for drug review in FY 1996 was $237.4, $85.1 from user fees and $152.3 from appropriated funds. The total funding for drug review in FY 1997 was $232.3, $84.3 from user fees and $148.0 from appropriated funds.  In 1998 the total amount spent on drug review was double that of FY 1992 at $253.4, $101.6 from user fees and $151.8 from appropriated funds.  In FY 1999 the total funding for drug review continuing to rise was $282.5, $122.5 from user fees and $160.0 from appropriated funds. In FY 2000 total funding for drug review was $314.9, $147.3 from user fees and $167.6 from appropriated funds. In FY 2001 the total funding for drug review was $323.4, $160.7 from user fees and $162.7 from appropriated funds.  In FY 2002 the total funding for drug review was $347.6, $161.8 from user fees and $185.8 from appropriated funds.  In FY 2003 the total funding increased to $409.5, $200.2 from user fees and $209.3 from appropriated funds.  In FY 2004 the total funding for drug review was $436.9 and the funds from user fees ($232.1) exceeded that of appropriated funds ($204.8).

 History of PDUFA Total Process and User Fee Funded FTEs

The number of full-time equivalent staff (FTEs) devoted to new drug review increased from 1,277 FTEs in FY 1992 to 2,561 in FY 2004, of which 1352 FTEs were funded by user fees and 1209 FTEs from non-user fees.  The total FTEs devoted to drug review in FY 1993 was 1400, 39 FTEs funded by user fees and 1305 non-user fees.  In FY 1994 there was a total of 1481 FTEs for drug review with 204 FTEs funded by user fees and 1277 non-user fees. The total number of FTEs for drug review in FY 1995 was 1747, 458 FTEs from user fees and 1294 from non-user fees.  In FY 1996, there were 1941 FTEs for drug review, 600 FTEs funded by user fees and 1341 funded by non-user fees. In FY 1997 the total number of FTEs for drug review was 1990, with 696 funded from user fees and 1294 from non-user fees.  The total number of FTEs rose slightly in FY 1998 to 2031 FTEs, 751 FTEs funded by user fees and 1280 from non-user fees.  In FY 1999 the total number of FTEs for new drug review was 2186 with 846 FTEs funded by user fees and 1340 from non-user fees.  In FY 2000 the total number of FTEs devoted to new drug review was 2345 FTEs with 1009 FTEs from user fees and 1336 from non-user fees.  In FY 2001 the total FTEs for drug review dropped slightly to 2340, with 1089 FTEs from user fees and 1251 from non-user fees.  In FY 2002 the total number of FTEs devoted to drug review dropped a little more to 2337 FTEs, 1060 FTEs from user fees and 1277 from non-user fees.  In FY 2003 the total FTEs for new drug review climbed to 2495, with 1201 funded by user fees and 1258 from non-user fees.  In FY 2004 the total FTEs for drug review rose to 2561 and the number of FTEs funded by user fees (1352 FTEs) exceeded the number of FTE review staff not funded by user fees (1209 FTEs).

 Median Approval Time for NDAs and BLAs

The median approval time for NDA and BLA original priority applications was 13.2 months and 22.1 for standard applications in FY 1993.  The median approval time for priority applications dropped slightly to 21.6 months and 12.2 months for standard applications in FY 1994.  The median approval time for priority applications dropped again to 11.8 months and 16.0 for standard applications in FY 1995.  The median approval time for priority applications dropped yet again to 14.7 months and 8.2 for standard applications in FY 1996.  The median approval time for priority applications continued to drop further to 7.8 months and 12.5 months for standard applications in FY 1997.  The median approval time for priority applications experienced another drop to 6.0 months; however, the review time for standard applications increase to 17.9 months in FY 1998.  The median approval time for priority applications remained at 6.0 months and dropped to 12.0 months for standard applications in FY 1999.    In 2000, the median approval time for priority applications remained at 6.0 month and increased again to 14.6 months for standard applications.  The median approval time for priority applications significantly increase to 15.6 months and 22.1 months for standard applications in FY 2001.  The median approval time for priority applications significantly dropped to 7.5 months and 12.8 months for standard applications in FY 2002.  The median time for approval dropped slightly to 6.4 months and rose slightly to 13.8 for standard applications in FY 2003.

 First Action Percentages for CDER Priority NMEs and New BLAs by Fiscal Year of Receipt

The first action percentages for CDER priority NMEs and new BLAs from FY 1993 through FY 2004 were as follows:  In FY 1993, of the 11 applications that received actions in their first cycle, 64% were approved, 27% received an approvable action, 9% were not approvable and none were withdrawn.  In FY 1994, of 10 applications, 30% were approved, 40% were considered approvable, 30% were not approvable and none were withdrawn.  In FY 1995, of the 12 applications, 42% were approved, 42% were approvable, 17% were not approvable and none were withdrawn.  In FY 1996, of the 16 applications, 63% were approved, 25% were approvable, 13% were not approvable and none were withdrawn.  In FY 1997, of the 15 applications, 27% were approved, 40% were approvable, 13% were not approvable and 20% were withdrawn.  In FY 1998, of the 16 applications, 50% were approved, 38% were not approvable, 6% were not approvable and 6% were withdrawn.  In FY 1999, of the 15 applications, 87% were approved, 13% were approvable and none were withdrawn or considered not approvable.  In FY 2000, of the 15 applications, 47% were approved, 40% were approvable, 13% were not approvable and none were withdrawn.  In FY 2001, of the 8 applications, 25% were approved, 50% were approvable, 13% were not approvable and 13% were withdrawn.  In FY 2002, of the 8 applications, 75% were approved, 13% were approvable, 13% were not approvable and none were withdrawn.  In FY 2003, of the 12 applications, 58% were approved, 33% were approvable, 8% were not approvable and none were withdrawn.  In FY 2004, of the 18 applications, 56% were approved, 33% approvable, 6% not approvable and 6% withdrawn.

 First Action Percentages for CDER Standard NMEs and New BLAs by Fiscal Year Receipt

The first action percentages for CDER standard NMEs and new BLAs from FY 1993 through FY 2004 were as follows:  In FY 1993, of the 17 applications that received actions in their first cycle, 18% were approved, 41% received an approvable action, 29% were not approvable and 12% were withdrawn.  In FY 1994, of 21 applications, 19% were approved, 38% were considered approvable, 38% were not approvable and 5% were withdrawn.  In FY 1995, of the 28 applications, 25% were approved, 43% were approvable, 29% were not approvable and 4% were withdrawn.  In FY 1996, of the 28 applications, 43% were approved, 39% were approvable, 18% were not approvable and none were withdrawn.  In FY 1997, of the 29 applications, 34% were approved, 34% were approvable, 17% were not approvable and 10% were withdrawn.  In FY 1998, of the 24 applications, 9% were approved, 57% were not approvable, 35% were not approvable and none were withdrawn.  In FY 1999, of the 22 applications, 32% were approved, 41% were approvable, 14% were approvable and 14% were withdrawn.  In FY 2000, of the 14 applications, 14% were approved, 57% were approvable, 14% were not approvable and 14% were withdrawn.  In FY 2001, of the 24 applications, 25% were approved, 46% were approvable, 25% were not approvable and 4% were withdrawn.  In FY 2002, of the 14 applications, 36% were approved, 57% were approvable, 7% were not approvable and none were withdrawn.  In FY 2003, of the 17 applications, 35% were approved, 59% were approvable, 6% were not approvable and none were withdrawn.  In FY 2004, of the 14 applications, 21% were approved, 64% approvable, 7% not approvable and 7% withdrawn.

 Percentage of NCEs/NASs First Launched in US 1980 through 2004 by PDUFA Cohort

The percentage of NCEs/NASs first launched in the US was 8.23% pre-PDUFA.  The percentage of NCEs/NASs first launched in the US tripled to 25.23% in PDUFA I and almost doubled again at 47.19% in PDUFA II.  The percentage of NCEs/NASs first launched in the US increased slightly to 50.00% during PDUFA III.

 Industry -- FDA Interactions During Development

The first industry/FDA interaction will be a Pre-IND meeting during the Preclinical Development phase, following the Basic Research and Prototype Design or Discovery stages.  Prior to beginning Phase I Clinical Development the sponsor will submit the initial IND for FDA review.  Throughout the Clinical Development Phases there will be ongoing submissions and interactions with the FDA in the IND Review Phase.  There will be milestone meetings during Phase 2 Clinical Development such as the End of Phase 2a Meeting and the End of Phase 2 Meeting prior to moving into Phase 3.  Prior to submitting the Market Application, there may be a Pre-BLA or NDA Meeting.  Once the Market Application is submitted the Application Review Stage begins which will include FDA Filing/Approval and review of launch material and safety update.

 Number of NDAs and BLAs Filed by Fiscal Year

The number of NDAs filed has increased from 81 in FY 1993 to 128 in FY 2004.  The number of BLAs has remained fairly constant with 7 in FY 1993 and 9 in FY 2004.  In FY 1994 there were 90 NDAs and 4 BLAs filed.  This increased to 106 NDAs and 12 BLAs filed in FY 1995.  In FY 1996 the number of filed NDAs (105) and BLAs (9) dropped slightly. The number of filed NDAs (117) and BLAs (16) increased again in FY 1997.  In FY 1998 the number of filed applications dropped to 109 NDAs and 12 BLAs.  In 1999 the number of filed NDAs rose to 121 and the filed BLAs dropped to 6.  In FY 2000 the number of NDAs filed remained at 121 and the number of filed BLAs rose to 13.  The number of filed NDAs (96) and filed BLAs (8) dropped in 2001.  In 2002 the number of filed NDAs (96) and BLAs (9) remained about the same, as well as in FY 2003 there were 101 NDAs and 8 BLAs filed.  In FY 2004 the number of NDAs filed rose sharply to 128 and the number of BLAs remained about the same at 9.

 Efficacy Supplements with Clinical Data Filed by Fiscal Year

The number of NDA and BLA efficacy supplements with clinical data filed has increased from 92 NDA and 8 BLA supplements in FY 1993 to 165 NDA and 19 BLA supplements in FY 2004.  In FY 1994 the number of NDA and BLA efficacy supplements filed dropped slightly to 86 NDA and 6 BLA.  In FY 1995 the NDA efficacy supplements filed dropped to 77 and the BLA supplements filed increased to 10.  In FY 1996 the number of NDA supplements filed increased to 103 and the number of BLA supplements filed decreased to 8.  The number of NDA and BLA efficacy supplements filed rose sharply in FY 1997 to 146 NDA and 15 BLA.  In FY 1998 the number of efficacy supplements filed dropped to 126 NDA and 10 BLA.  In FY 1999 the number of NDA efficacy supplements filed increased to 135 and the number of BLA supplements remained at 10.  The number of NDA efficacy supplements filed rose sharply in FY 2000 and the number of BLA supplements rose slightly to 12.  In FY 2001 the number of BLA efficacy supplements filed increased to 12 and the number of NDA supplements decreased to 152.  In FY 2002 the number of NDA efficacy supplements filed increased slightly and the BLA supplements filed decreased to 11.  In FY 2003 the number of NDA efficacy supplements filed decreased to 138 and the BLA supplements increased to 15.  In FY 2004 there was an increase in both NDA (165) and BLA (19) efficacy supplements filed.

 Number of CMC Supplements Submitted by Fiscal Year

The number of CMC supplements submitted for NDAs and BLAs has increased sharply from 1045 NDA and 202 BLA CMC supplements in FY 1993 to 1616 NDA and 885 BLA CMC supplements in FY 2004.  The number of CMC supplements submitted dropped in FY 1994 to 871 NDA and 186 BLA.  In FY 1995 the number of CMC supplements rose to 1249 for NDAs and 273 BLAs.  The number of CMC supplements dropped slightly to 1218 NDA and 261 BLA in FY 1996.  The number of CMC supplements increased slightly to 1262 NDA and 338 BLA in FY 1997.  The number of CMC supplements submitted continued to rise in FY 1998 to 1463 NDA and 371 BLA.  In FY 1999 the number of NDA CMC supplements remained about the same at 1459 while the BLA CMC supplements continued to climb to 477.  In FY 2000 the NDA CMC supplements dropped to 1438 and the BLA CMC supplements continued upward to 590.  The number of CMC supplements submitted in FY 2001 rose< slightly to 1474 NDA and 599 BLA.  There was a sharp increase in the number of CMC supplements submitted in FY 2002 at 1759 NDA and 717 BLA.  In FY 2003 the number of BLA CMC supplements continued to rise to 902 and NDA CMC supplements decrease slightly to 1696.  The number of CMC supplements submitted dropped slightly in FY 2004 to 1616 NDA and 865 BLA.

 Number of Meetings Scheduled with Industry Sponsors By Fiscal Year

The number of meetings scheduled with industry sponsors was 1555 in FY 1999 which dropped to 1335 meetings in FY 2000.  The number of industry meetings scheduled increased to 1547 in FY 2001 and 1642 meetings in FY 2002.  The number of industry meetings scheduled continued to climb to 1774 in FY 2003 and 2132 meetings in FY 2004.

 Special Protocol Assessment Submissions by Fiscal Year

The number of special protocol assessments (SPAs) submitted in FY 1999 was 71.  The number of SPAs submitted rose to 125 in FY 2000 and then remained constant with 125 SPAs submitted in FY 2001.  The number of SPAs submitted almost doubled to 248 in FY 2002.  The number of SPAs submitted continued to climb to 293 in FY 2003 and 346 SPAs in FY 2004.

 FDA response to Sponsor’s Complete Response to IND Clinical Hold

The number of FDA responses to sponsor’s complete response to clinical hold was 42 in FY 1998.  The number of FDA responses to sponsor’s complete response to clinical hold tripled to 125 in FY 1999.  In FY 2000 the number of FDA responses to sponsor’s complete response to clinical hold rose slightly to 137.  The number of FDA responses to sponsor’s complete response to clinical hold continued to rise to 158 in FY 2001 and 171 in FY 2002.  The FDA responses to sponsor’s complete response to clinical hold dropped to 133 in FY 2003 and then stayed steady at 135 in FY 2004.

 CBER Budget History FY2001-FY2005

The funding for CBER from appropriations was $83,796, the funding from user fees $36,217, and earmarks were $2,200 in FY 2001.  The funding in FY 2002 remained about the same with $86,644 from appropriations, $38,257 from user fees, and $0 from earmarks.  The CBER funding increased modestly in FY 2003 to $94,681 from appropriations, $47,116 from user fees and $0 from earmarks.  The funding for CBER  from< appropriations in FY 2004 decreased to $61,134, user fees decreased slightly to $43,607 and $0 came from earmarks.  The funding for CBER from appropriations in FY 2004 decreased slightly to $55,073, the user fee funding increased slightly to $46,203 from user fees and $150 came from earmarks.

 CDER Budget History FY2001-FY2005

The funding for CDER in FY 2001 was $145,622 from appropriation, $96,995 from user fees, and $150 from earmarks.  The funding increased slightly in FY 2002 to $154,658 from appropriations, $104,093 from user fees and $400 from earmarks.  The CDER funding from appropriations again rose slightly in FY 2003 to $161,920, while the funding from user fees increased at a higher percentage rate to $125,103 and $750 were from earmarks.  In FY 2004 the funding for CDER from appropriations dropped to $142,339, the funding from user fees surpassed that of appropriations at $162,653 and the funding from earmarks increased dramatically to $53,750.  In FY 2005 the funding for CBER from appropriations continued to drop to $138,183, the funding from user fees again rose sharply to $199,762 and there was $56,000 from earmarks.

 PDUFA FTE Paid for by Planned vs, Actual Appropriations and FEE Funds

The number of FTEs that were planned to be paid by appropriations was 1277 and the actual paid for was 1258 in FY 2003.  The number of FTEs planned to be funded by user fees was 1192 and actual funded was 1201 in FY 2003.  The number of FTEs planned to be paid for by appropriations in FY 2004 was 1277 and the number of FTEs actually funded dropped to 1153.  The number of FTEs planned to be funded by user fees in FY 2004 was 1273 and the actual number of FTEs funded was higher at 1352.  The number of FTEs planned to be funded by appropriations from FY 2005-FY2007 is 1277.  The number of FTEs planned to be funded by user fees is 1373 in FY 2005, 1435 in FY 2006 and 1464 in FY 2007.

 CDER Commercial IND vs. Meeting Workload

The number of commercial INDs submitted to the FDA was 410 and research INDs 621 in FY 1997.  The number of commercial INDs (415) and research INDs (610) submitted was about the same in FY 1998.  In 1999 the number of commercial INDs was 414, research INDs 553, and the number of meetings scheduled 1555.  In FY 2000 the number of commercial INDs (443) remained steady and the number of research INDs (482) and meetings (1335) dropped.  In FY 2001 the number of meetings rose to 1547 while the number of commercial INDs fell to 407 and research INDs to 441.  The number of commercial INDs submitted was 412, research INDs rose to 606, and the number of meetings scheduled continued to rise to 1642 in FY 2002.  The number of commercial INDs (495) and research INDs (640) received by FDA in FY 2004 were about the same as previous years though the number of meetings scheduled increased to 1774.  In 2005 the number of meetings scheduled continued to rise to 2132 even though the number of commercial INDs (535) and research INDs (610) were steady.

 Serious Adverse Event Reports to FDA

The number of manufacturer (MFR) 15-day reports received by the FDA in FY 1990 was 11,411.  There were 12, 824 MFR 15-day reports received in FY 1991; 15,952 in FY 1992; 19,112 in FY 1993; 22,204 in FY 1994; 21,837 in FY 1995; and 26,315 in FY 1996.  The MFR 15-day reports received by the FDA starting to increase dramatically to 37,866 in FY 1997; 71,642 in FY 1998; 81,600 in FY 1999; 95,029 in FY 2000; 115,011 in FY 2001; 128,866 in FY 2002; 144,313 in FY 2003 and finally almost a 9 fold increase to 160,940 in FY 2004.

 Number of Broadcast Drug Ads Proposed (Submitted for FDA Review) vs. Disseminated (Not reviewed by FDA)

The number of broadcast ads proposed (submitted for FDA review) was 188 and disseminated (not reviewed by FDA) was 105 in FY 1999.  In 2000 the number of proposed broadcast ads was 201 and the number of disseminated ads more than doubled to 242.  The number of proposed ads dropped significantly to 128 in 2001 while the proposed ads received was about the same at 248.  The number of proposed ads received by FDA increased to 191 and disseminated ads to 295 in FY 2002.  In FY 2003 the proposed ads received dropped to 153 and the disseminated increased slightly to 311.  The disseminated ads received by FDA rose sharply in FY 2004 to 441 while the proposed ads received dropped to 142.