• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

FY 2006 PDUFA Financial Report: Appendices

<< Return to FY 2006 PDUFA Financial Report: Table of Contents View the Main Report >>

 

(PDF version of the entire FY 2006 PDUFA Financial Report - 306 KB)


Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.

 


 

Quick Links

 

 


  

Appendix A: Conditions for Assessment and Use of Fees

 

The Federal Food, Drug, and Cosmetic Act (the Act) specifies three major conditions that must be met each year before prescription drug user fees may be collected and spent.  A summary of these conditions and how FDA met them appears on page 2.  A more detailed description of each of these conditions is provided below, with an explanation of how FDA met the condition in FY 2006.

For making the calculations to determine if statutory conditions are met, an adjustment factor must be used.  It is defined in section 735(8) of the Act, as follows:

The term 'adjustment factor' applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for April of the preceding fiscal year divided by such Index for April 1997.

The consumer price index for April 2005, the fiscal year preceding FY 2006, was 194.6.  The consumer price index for April 1997 was 160.2.  The result of this dividing 194.6 by 160.2 is an adjustment factor of 1.2147 for FY 2006. 

The first condition is based on section 736(f)(1) of the Act.  It states:

Fees under subsection (a) shall be refunded for a fiscal year beginning after FY 1997 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

This provision does not allow FDA to collect or spend user fees unless FDA's total Salaries and Expenses appropriation (excluding user fees) each year are greater than or equal to FDA's FY 1997 Salaries and Expenses appropriation (excluding user fees) multiplied by the adjustment factor.  FDA's total FY 1997 Salaries and Expenses appropriation (excluding user fees) was $819,971,000.  Multiplying this amount by the adjustment factor of 1.2147, an adjusted FY 1997 Salaries and Expenses Appropriation (excluding user fees, and rounded to the nearest thousand dollars) is $996,019,000.

In FY 2006, FDA's total Salaries and Expenses appropriation (excluding user fees and excluding rent to GSA, which was also not included in the FY 1997 appropriation amount) was $1,370,398,000.  Because the FY 2006 appropriation exceeded the FY 1997 adjusted amount, the first condition was met.

The second condition is stated in Section 736(g)(2)(A)(i): that fees "shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation acts, or otherwise made available for obligation, for such fiscal year…."

The President signed the Appropriation Act that specified the amounts collectable from prescription drug user fees in FY 2006 ($305,332,000) on November 10, 2005 (Public Law 109-97). Therefore, the second condition was met.

The third condition in Section 736(g)(2)(A)(ii), states that fees:

Shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor.

In FY 1997, FDA's actual obligation for the review process of human drug applications (excluding obligations paid from user fees) was $147,959,689, as reported in the FY 1997 Financial Report to Congress.  Multiplying this amount by the adjustment factor of 1.2147, FDA's 1997 adjusted minimum spending for the human drug applications review process from appropriations (exclusive of user fees) was $179,726,634 in FY 2006. 

In FY 2006, FDA obligated $218,659,186 from appropriations for the human drug applications review process.  Because $218,659,186 is greater than $179,726,634, the third condition was met.

The table below provides the amounts that FDA spent on the review process of human drug applications in FY 2005 and FY 2006, and the adjusted FY 1997 amount that had to be spent from appropriations.  It also provides the amounts of these costs derived from appropriations and from user fees in each fiscal year.

Food and Drug Administration
Obligations for the Process for the Review of Human Drug Applications
As of September 30, 2006
   FY 1997
Adjusted for FY 2006
 FY 2005  FY 2006
From Appropriations
$179,726,634
$211,518,383
$218,659,186
From User Fee Revenues
 
$269,433,800
$305,644,137
Total Obligations
 
$480,952,183
$524,303,323

Return to top

 


  

Appendix B: Exemptions and Waivers

 

Beginning in FY 1993, PDUFA directed FDA to waive or reduce fees in five different circumstances:

  • when a waiver is necessary to protect the public health;
  • when a fee is a significant barrier to innovation;
  • when the fees paid exceed FDA's costs of reviewing a firm's human drug applications;
  • when imposition of the fee creates an inequity between certain 505(b)(1) and 505(b)(2) human drug applications (This waiver provision was deleted in PDUFA III); and
  • when a sponsor withdraws a pending human drug application after FDA has filed it, but before FDA has performed substantial work on the marketing application.

In addition, under PDUFA II, new exemptions from application fees were added beginning in FY 1998.  These specific exemptions are automatic and do not require a waiver request.  They include:

  • human drug applications only for designated orphan products (designated for rare diseases or conditions affecting fewer than 200,000 patients in the United States);
  • supplemental applications for pediatric indications for use. (Statutorily repealed by section 5 of Public Law 107-109, effective January 4, 2002).

Beginning in FY 1998, PDUFA II also provided a waiver for certain small businesses for the full application fee for the first application submitted.  Before FY 1998, only half of the application fee was waived for small businesses.

The increased number of exemptions required by PDUFA II reduced the number of applications that pay fees. 

Fees may be waived or reduced under the waiver provisions of the statute.  Many of the application fee waiver requests FDA received through FY 1997 pertained to orphan products; since designated orphan products are now given automatic exemptions, the number of waiver requests for application fees has decreased substantially. 

The tables on the following page summarize the exemption and waiver actions taken by FDA for fees payable in the five most recent fiscal years.

EXEMPTIONS AND WAIVERS AS OF SEPTEMBER 30, 2006
Does not Include Data on FY 2007 Waivers Granted in FY 2006

Exempted Application Fees: 1

 

  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006
Orphan Product 10.0 13.5 19.5 28.5 23.8
Pediatric Supplements 2 4.5        
Previously Submitted 3 7.5 3.0 8.0 3.5 6.0
Total Exemptions 22.0 16.5 27.5 32.0 29.8
TOTAL Value of Exemptions $6,893,040 $8,801,100 $15,771,250 $21,504,000 $22,830,150

 

Waived Fees: 

APPLICATIONS 1

  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006
Small Business Waivers 4 6.0 14.3 16.3 12.0 9.8
Miscellaneous Waivers 5 1.0 1.0 1.0 12.0 7.0
Value of Waivers Approved $2,193,240 $8,134,350 $9,892,875 $16,128,000 $12,853,950

 

PRODUCTS

  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006
Waivers Approved 14.0 31.9 50.0 27.0 17.0
Value of Waivers Approved $302,820 $1,033,560 $1,804,000 $1,126,170 $716,210

 

ESTABLISHMENTS

  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006
Waivers Approved 12.3 17.5 22.0 16.5 11.0
Value of Waivers Approved $1,716,335 $3,673,250 $4,989,600 $4,322,891 $2,904,000
  FY 2002 FY 2003 FY 2004 FY 2005 FY 2006
TOTAL VALUE —
All Waivers Granted
$4,212,395 $12,841,160 $16,686,475 $21,577,061 $20,635,384

 1 Applications counted in full-fee equivalents.

 2 The exemption for pediatric supplements was repealed by P. L. 107-109 effective January 4, 2002.

 3 Prior to FY 2002 these were included in the total for Miscellaneous waivers.

 4 Prior to FY 2002 this category was included in counts of applications for which fees were exempted. Applications for all exemptions may not have been received.

 5 Prior to FY 2002 this category also included counts of applications for which fees were exempted because applications had been submitted previously or which were not included in the definition of applications that paid fees.

Return to top

 


  

Appendix C: Allowable and Excluded Costs for the Process for the Review of Human Drug Applications

 

PDUFA and the related House of Representatives Reports 102-895 and 107-481 ("House Reports"), defines the process for the review of human drug applications and the costs that may be included in that process.  Using these definitions (and further refinements identified below) and the methodologies described in this report, the Agency identified those activities that were applicable to the process for the review of human drug applications.

Over 96 percent of amounts obligated are expended within 2 years.  Therefore, obligations represent an accurate measure of costs.

 

User Fee Related Costs

Section 735(6) of the Act defines in general terms the activities necessary for the review of human drug applications (the "human drug review process").  In summary, costs related to the following process activities have been attributed to the process for the review of human drug applications:

  • All investigational new drug (IND) review activities, including amendments
  • All review activities for new drug applications (NDAs), biologic license applications (BLAs), including supplements and amendments
  • Regulation and policy development activities related to the review of human drug applications
  • Development of product standards for products subject to review and evaluation
  • Meetings between the Agency and the sponsor of a covered application or supplement
  • Review of labeling prior to approval of a covered application or supplement and the review of the initial pre-launch advertising
  • Review of post-marketing studies that have been agreed to by sponsors as a condition for approval
  • Inspections of facilities undertaken as part of the review of pending applications or supplements
  • Lot release activities for covered biological products
  • Assay development and validation to ensure batch-to-batch consistency and reliability for covered biological products
  • Monitoring of clinical and other research conducted in connection with the review of human drug applications
  • User Fee Act implementation activities
  • Research related to the human drug review process — although under PDUFA II FDA phased out research supported by fee revenues, and
  • In the case of drugs approved after October 1, 2002, under human drug applications or supplements:  collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years — added under PDUFA III.

All user-fee related costs represented by the above activities are collectively referred to in this report as costs for the process for the review of human drug applications.

Section 735(7) of the Act defines the "costs of resources allocated for the process for the review of human drug applications" as the expenses incurred in connection with this process for:

(A) officers and employees of the FDA, contractors of the FDA, advisory committees, and costs related to such officers, employees, committees and contracts; 
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting user fees under section 736 of the Act and accounting for resources allocated for the review of human drug applications and supplements.

 

User Fee Excluded Costs

The Act excludes costs related to the following:

Excluded Products

  • Generic drugs
  • Over-the-counter drugs not associated with an NDA or NDA supplement
  • Large volume parenteral drug products approved before September 1, 1992
  • Allergenic extract products
  • Whole blood or a blood component for transfusion
  • In vitro diagnostic biologic products
  • Certain drugs derived from bovine blood

Excluded Process Activities

  • Enforcement policy development
  • Post-approval compliance activities
  • Advertising review activities once marketing of the product has begun
  • Inspections unrelated to the review of covered applications
  • Research unrelated to the human drug review process

These inclusions and exclusions required accounting for a newly created subset of FDA activities after the fact.  It was necessary to develop and implement a methodology that would allow the Agency retrospectively to capture the FY 1992 costs for the newly defined "process for the review of human drug applications," and apply that same methodology for future years.   In 1995, Arthur Andersen & Company independently reviewed FDA procedures for doing this and found the methodologies reasonable.

Return to top

 


  

Appendix D: Development of Costs for the Process for the Review of Human Drug Applications

 

General Methodology

The costs associated with the process for the review of human drug applications are based on obligations recorded within FDA's Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC).  These organizations correspond to the cost categories presented on the Statement of Costs for the Process for the Review of Human Drug Applications as follows:

Cost Category FDA Organization
Costs for the Review of New Drug Applications (NDA's),
Biologic License Applications (BLA's), and Supplements
CDER
Costs for the Review of BLA's and Supplements
CBER
Field Inspection and Investigation Costs
ORA
Agency General and Administrative Costs
OC

The costs were accumulated using time reporting systems in CDER, CBER, and ORA, and were extrapolated for OC.  Using the definitions of costs and activities included in the "process for the review of human drug applications" in the Act, a portion of the costs within each of the four organizations listed above was identified as part of the human drug review process.

 

Center Costs

Costs are accumulated in CDER and CBER in cost centers corresponding to the organizational components (usually divisions) within the Centers.  Most FDA components involved in the human drug review process perform a mixture of activities — some included in the definition of the process for the review of human drug applications, and some not included.  These components fall into three categories: 1) direct review and laboratory components; 2) indirect review and support components; and 3) center-wide expenses.  The allocation of costs for the three categories is discussed below.

Direct Review and Laboratory Components

Employees in all components of CDER and CBER, other than those noted below as center indirect review and support components, reported their time for eight weeks during FY 2006 in activities that could be used to differentiate between time spent on the process for the review of human drug applications and all other time.

Both CDER and CBER time reporting systems were modified after the enactment of PDUFA, so that time could be reported in activities that could be separated into allowable and excluded activities with respect to the process for the review of human drug applications, as defined in PDUFA and as further explained in Appendix C.  This method for determining allowable and excluded costs for PDUFA direct review and laboratory costs has been used consistently, with only minor modifications, since 1993, when costs were initially measured by Arthur Andersen & Company.  Beginning in FY 1996, the CBER time reporting system was enhanced to collect on-line time reports for all employees other than management and administrative support personnel for a 2-week period each quarter of the fiscal year.   The enhanced system reports time for 50 possible functional activities, by 7 product classes. 

In November 1997, CDER initiated an on-line time reporting survey of each employee within the Center.  Beginning in FY 2001, this survey captures the expenditure of time on activities that are part of the process for the review of human drug applications and all other CDER mission-oriented activities for two 4-week periods — one in each half of the fiscal year.

A similar procedure is used in CBER's direct review and laboratory components to measure costs for the process for the review of human drug applications.  CBER's time reporting system was validated by studies just after PDUFA was initiated.  That system collects time reports on-line from all employees other than management and administrative support personnel for a 2-week period during each quarter of the fiscal year. 

FDA Centers are very payroll-intensive organizations — 61 percent of all FDA funds pay for employee salaries and benefits, and almost all other costs are directly supporting these employees.  Thus the average percentage of time reported each year during this 8-week period (2 weeks each quarter for CBER, and 4 weeks semiannually for CDER) as having been expended on drug review process activities for each cost center is then applied to all costs incurred for each cost center for the entire fiscal year to estimate the costs for each cost center that were part of the process for the review of human drug applications.

Center Indirect Review and Support Components

Indirect review and support components provide the infrastructure for the review process.  In CDER, these components include portions of the Office of the Center Director, the Office of Regulatory Policy, the Office of Business Process Support, the Office of Management, the Office of Training and Communications, the Office of Medical Policy, the Office of Executive Programs, and the Office of Compliance.  In CBER, these components include portions of the Office of the Center Director, Office of Management, Office of Information Management, and the Office of Communications, Training, and Manufacturers Assistance.  Most employees of these components do not report their time.

Instead, the time of the management and administrative support personnel is assumed to be the average percentage time of all Center employees in direct review and laboratory components who reported their time.  Thus the average percentage of time reported each year during this 8-week period as having been expended on drug review process activities for all direct review and laboratory components was then applied to all costs incurred for the entire fiscal year by the indirect review and support components.

Center-Wide Expenses

A number of Center-wide expenses are paid from central FDA accounts rather than charged directly to a specific Center.  These costs include rent for facilities that house drug review staff, telecommunications and utility costs, some computer equipment and support costs, facilities repair and maintenance, and some extramural and service contracts.  Many of these costs were traced back to the specific division that generated the cost and were assigned the user fee percentage calculated for the division to which the expenditure related.  For the costs that benefited the Center as a whole and could not be traced to a specific division, a weighted average user fee percentage was calculated based on the level of user fee related costs to total costs in the Center.

In support of the President's Management Agenda and Secretarial Goal of "One-HHS," FDA consolidated administrative functions from the Centers and the Office of Management (including facilities, procurement, finance, EEO, and IT services) into the Office of Shared Services in FY 2004.   The goal of implementing the Office of Shared Services is to keep the administrative functions related to the review costs more efficient.

In the FY 2006 financial report, the resources that were previously provided by the Centers, but are now provided by the Office of Shared Services, are reported as if they were still performed by the Centers, in order to make the FY 2006 report comparable with the reports of previous years. 

 

Center Research Covered by the Prescription Drug User Fee Act

Research activities supporting the process for the review of human drug applications were included when FDA originally calculated base costs for the process for the review of human drug applications for FY 1992 and FY 1993.  Under PDUFA I, from FY 1993 through FY 1997, both appropriated funds and user fee revenues were used to fund research activities supporting the drug review process, just as was the case with all other PDUFA activities.  During informal discussions that led to PDUFA II, FDA agreed to phase out the use of fee revenues to support these research costs.  The phase-out was complete in FY 2001. The remaining research related to the drug review process is now supported solely by appropriated funds, just as it was prior to FY 1993.

 

Center Time Reporting Results for FY 2006

The time reporting systems operated by CBER and CDER indicated the 65 percent of all time spent in CBER and 78 percent of all time spent in CDER in FY 2006 was dedicated to the process for the review of human drug applications as defined in PDUFA.

 

Field Inspection and Investigation Costs

FDA's ORA incurs all field inspection and investigation costs.  ORA costs are incurred in both district offices (the "field") and headquarters support offices.  In FY 2002, the agency began tracking accumulated ORA costs through the use of the Field Accomplishment and Compliance Tracking System [FACTS].  FACTS is a time and activity tracking system which captures time in a variety of categories, including pre-approval inspections of manufacturing facilities, investigations of clinical studies, and analytical testing of samples — which are included in the process for the review of human drug applications.

Total direct hours reported in FACTS are used to calculate the total number of staff-years required by ORA to perform these activities.  In addition to the direct time, an allocation of support time is also included to represent the work done by the ORA administrative and management personnel.  The agency then applies the total number of user fee related staff years to the average salary cost in ORA to arrive at ORA user fee related salary costs.  The final step is to allocate ORA obligations for operations and rent to the human drug review process based upon the ratio of user fee related staff years to total ORA staff years.  The following table summarizes the calculation of ORA costs for the review of human drug applications for FY 2005 and FY 2006.

Food and Drug Administration
Office of Regulatory Affairs
Costs of the Process for the Review of Human Drug Applications

As of September 30, 2006
Cost Component FY 2005 FY 2006
Staff Years Utilized
145
142
ORA Average Salary and Benefits
$93,594
$99,675
Salary and Benefits
$13,571,103
$14,153,875
Operations, Rent, and Shared Services
$9,019,155
$9,106,177
TOTAL
$22,590,258
$23,260,052

The ORA costs for the process for the review of human drug applications described above include total process costs, including costs paid from appropriations and costs paid from fee revenues.

 

Agency General and Administrative Costs

The agency general and administrative costs are incurred in the FDA's OC.  During most of FY 2006, OC was comprised of the following offices:

  • Immediate Office of the Commissioner
  • Office of the Chief Counsel
  • Office of Equal Employment Opportunity and Diversity Management
  • Office of the Administrative Law Judge
  • Office of Science and Health Coordination
  • Office of International Activities and Strategic Initiatives
  • Office of Crisis Management
  • Office of Legislation
  • Office of External Relations
  • Office of Policy and Planning
  • Office of Management

The OC costs applicable to the process for the review of human drug applications were calculated using a method prescribed by the Division of Cost Determination Management, Office of Finance, Office of the Assistant Secretary for Resources and Technology, Office of the Secretary, Department of Health and Human Services.  The method uses the percentage derived by dividing total OC costs by the total salary obligations of the agency, excluding the OC.  That percentage is then multiplied by the total salaries (excluding benefits) applicable to the process for the review of human drug applications in CDER, CBER, and ORA to arrive at the total General and Administrative Costs.

Using this process, $31,081,277 and $33,793,968 in general and administrative obligations were dedicated to the human drug review process in FY 2005 and FY 2006, respectively.   They are the total costs, including the funds obligated both from appropriations and user fees.  The agency general and administrative obligations in FY 2006 accounted for 6.4 percent of the total costs of the human drug application review process.  This is down from FY 2005, when general administrative obligations accounted for 6.5 percent of the costs of the human drug applications review process.  This continues a downward trend over the last several years.  This percentage has steadily declined from the 10.4 percent reported in the FY 1998 PDUFA Financial Report.

Return to top

 


  

Appendix E: Risk Management Component of Costs for the Process for the Review of Human Drug Applications

 

Requirement for this Appendix

PDUFA III expanded the definition of the drug review process to include collecting, developing or reviewing safety information on drugs, including adverse event reports, for up to 3 years after a product is approved.  The performance goals letter specifies that FDA is to allocate $70.9 million in user fees over 5 years to these activities and that FDA will include in its annual report to Congress an accounting of this spending.  This appendix responds to this requirement.

 

Initial Plan for Risk Management Spending

In July 2003 FDA published its PDUFA III Five-Year Plan that included information on its plan to spend the risk management funds.  The table below provides a summary of those plans.

Summary Risk Management Spending Plan
From FDA's July 2003 PDUFA III Five-Year Plan
($000)
  FY 2003
Plan
FY 2004
Plan
FY 2005
Plan
FY 2006
Plan
FY 2007
Plan
Additional Staff Years
19
34
56
84
96
Payroll for Additional Staff Years
$2,020
$3,721
$6,539
$10,160
$12,218
Operating Support
$231
$420
$730
$1,129
$1,359
Contract Support
$4,480
$5,172
$6,273
$4,608
$5,079
GSA Rent &
Rent Related
$183
$328
$551
$835
$998
Central
Support
$240
$429
$734
$1,132
$1,375
TOTAL
$7,154
$10,07
$14,82
$17,86
$21,02

 

Actual Risk Management Obligations

The table below shows amounts FDA has obligated for risk management activities as of the end of FY 2003 to FY 2006, and the planned obligations for FY 2007 that remains unchanged from the original plan.

  FY 2003
Actual
FY 2004
Actual
FY 2005
Actual
FY 2006
Actual
FY 2007
Plan
Additional Staff Years
19
37
62
100
96
Payroll for Additional Staff Years
$2,270
$4,695
$7,401
$12,339
$12,218
Operating Support
$204
$292
$463
$1,005
$1,359
Contract Support
$3,974
$5,349
$6,193
$6,686
$5,079
GSA Rent &
Rent Related
$181
$204
$551
$1,437
$998
Central
Support
$244
$615
$806
$1,514
$1,375
TOTAL
$6,873
$11,155
$15,414
$22,981
$21,029

As the table above shows, FDA has spent slightly less than planned in FY 2003 and slightly more than planned in FY 2004 to FY 2006.  At this rate, FDA expects to spend at least the expected $70.9 million on risk management activities over the course of PDUFA III.

The FTE for risk management funded over the period FY 2003 to FY 2006, and planned for FY 2007, broken out by Center, are provided in the following table.

FTE paid from Risk Management Funds as of September 30, 2006
and planned for obligation in FY 2007
Component FY 2003
Actual
FY 2004
Actual
FY 2005
Actual
FY 2006
Actual
FY 2007
Plan
CDER
11
26
51
86
78
CBER
5
7
7
9
12
OC
3
4
4
5
6
FDA Total
19
37
62
100
96

Additional funding for risk management activities from PDUFA fees has enabled FDA to increase its public health and consumer protection efforts in overseeing the safety of newly approved drug products during their first two or three years on the market.  PDUFA risk management funds have made it possible to increase the number of staff responsible for assuring the safety of drug products during the periapproval period.  FDA has been able to hire more scientists, including epidemiologists, drug utilization specialists, and safety evaluators. 

Fees have also been used to partially finance operations expenses for the primary safety evaluator tool, the Adverse Event Reporting System.  In the last few years, FDA has experienced a substantial increase in reports of drug adverse events.  Additional resources have helped ensure that adverse event reports are entered in an accurate, complete, and timely manner. 

Fees have also enabled FDA to continue to fund drug utilization contracts to supply the agency with data on drug use.  These data provide important information regarding numbers of dispensed prescriptions, patient demographics, diagnoses, trends over time, and sales volume for various groups such as outpatients, inpatients, and children.  User fees have provided resources to make these databases available for investigation of important safety signals identified during surveillance.

Return to top

 

<< Return to FY 2006 PDUFA Financial Report: Table of Contents