GAO-12-650R FDA Employee Performance Standards

United States Government Accountability Office

Washington, DC 20548

April 18, 2012

The Honorable Richard Burr

Ranking Member

Subcommittee on Children and Families

Committee on Health Education Labor and Pensions

United States Senate

The Honorable Tom Coburn

Ranking Member

Permanent Subcommittee on Investigations

Committee on Homeland Security and Governmental Affairs

United States Senate

Subject: Food and Drug Administration: Employee Performance Standards for the 

Timely Review of Medical Product Applications

This report formally transmits the attached briefing in response to your request that 

we provide information on the standards that the Food and Drug Administration 

(FDA) considers when assessing the performance of its employees. (See the 

enclosure.) You asked whether the agency’s timeliness goals for processing medical 

product applications are reflected in the performance standards for FDA employees 

who have a role in reviewing these applications. These timeliness goals are one 

aspect that FDA may consider in assessing employee performance. The extent to 

which these goals are reflected as explicit expectations in employee performance 

standards varies by an employee’s duties, level of responsibility, and organizational 

component. We provided the briefing to your staff on April 17, 2012.

– – – – – 

As agreed with your offices, unless you publicly announce the contents of this report 

earlier, we plan no further distribution until 30 days from the report date. At that time, 

we will send copies to the Commissioner of FDA and appropriate congressional 

committees. The report also will be available at no charge on the GAO website at 

http://www.gao.gov. 
2 GAO-12-650R FDA Employee Performance Standards

If you or your staff have any questions regarding this report, please contact me at 

(202) 512- 7114 or crossem@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page of this 

report. Key contributions to this report were made by Geri Redican-Bigott, Assistant 

Director; Kelly DeMots; Cathleen Hamann; Hannah Marston Minter; and Lisa Motley.

Marcia Crosse

Director, Health Care

Enclosure
Enclosure

3 GAO-12-650R FDA Employee Performance Standards

1

Food and Drug Administration: Employee 

Performance Standards for the Timely Review of Medical 

Product Applications 

Briefing for the staff of 

The Honorable Richard Burr

Ranking Member

Subcommittee on Children and Families

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Tom Coburn

Ranking Member

Permanent Subcommittee on Investigations

Committee on Homeland Security and Governmental Affairs 

United States Senate

April 17, 2012
Enclosure

4 GAO-12-650R FDA Employee Performance Standards

2

Overview

• Introduction

• Objective

• Scope and Methodology

• Background

• Results

• Agency Comments
Enclosure

5 GAO-12-650R FDA Employee Performance Standards

3

Introduction

• The Food and Drug Administration (FDA) is responsible for 

overseeing the safety and efficacy of medical products—drugs, 

devices, and biological products—sold in the United States. 

Sponsors of these products submit applications to FDA for 

review.* FDA approval or clearance is generally required before 

marketing.

• In 2007, Congress reauthorized the two user fee programs 

under which FDA receives resources to support the process of 

reviewing applications for new medical products through the 

Prescription Drug User Fee Amendments (PDUFA) and the 

Medical Device User Fee Amendments (MDUFA).

*We use the term “application” to include applications, submissions, and notifications related to medical product 

review.
Enclosure

6 GAO-12-650R FDA Employee Performance Standards

4

Introduction

• PDUFA and MDUFA provide for funding for FDA through 

user fees collected from the sponsors of new medical 

products for fiscal years 2008 through 2012.

• Under PDUFA and MDUFA, FDA committed to 

performance goals in order to ensure the timely review of 

certain new medical product applications.

• The details of these agency performance goals are 

negotiated between FDA and industry stakeholders, and 

include specific time frames within which FDA is to take 

action on a certain percentage of applications. 
Enclosure

7 GAO-12-650R FDA Employee Performance Standards

5

Introduction

• FDA employees who review medical product applications 

may include biologists, chemists, engineers, medical 

doctors, microbiologists, pharmacologists, statisticians, 

and other experts. 

• In addition, some officers of the U.S. Public Health Service 

Commissioned Corps are stationed at FDA. 

Commissioned Corps officers may serve in a variety of 

federal agencies in various capacities, including disease 

control and prevention, biomedical research, and health 

care delivery. Officers stationed at FDA—like FDA 

employees—may review medical product applications.
Enclosure

8 GAO-12-650R FDA Employee Performance Standards

6

Introduction

• We recently reported on FDA’s timeliness in meeting 

performance goals related to its review of medical 

devices. As part of that report, we found that FDA had not 

met a subset of these performance goals.* 

*See GAO, Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer, GAO-12-418

(Washington, D.C.: Feb. 29, 2012).
Enclosure

9 GAO-12-650R FDA Employee Performance Standards

7

Objective

• Given FDA’s commitment to meeting specific performance 

goals, you asked whether these agency goals are 

included in employee performance standards. This 

briefing examines the extent to which FDA includes the 

timeliness of new medical product application reviews in 

standards used to assess employee performance, 

including any mention of PDUFA- or MDUFA-related 

goals.
Enclosure

10 GAO-12-650R FDA Employee Performance Standards

8

Scope and Methodology

• We reviewed documentation of standards for employee 

performance for three centers at FDA—the Center for Drug 

Evaluation and Research (CDER), the Center for Biologics 

Evaluation and Research (CBER), and the Center for 

Devices and Radiological Health (CDRH). These centers 

identified the employee positions involved with new medical 

product application reviews.

• Specifically, we reviewed standards for employee 

performance which are contained in employee performance 

plan templates. These templates are standardized by 

employee position and maintained separately by each center. 

The centers may customize these templates to create 

individual performance plans for each employee. 
Enclosure

11 GAO-12-650R FDA Employee Performance Standards

Scope and Methodology

• We interviewed officials from FDA, including officials from 

CDER, CBER, and CDRH. Because officers of the U.S. 

Public Health Service Commissioned Corps may be 

stationed at FDA and involved in medical product 

application reviews, we also interviewed an officer of the 

Commissioned Corps.

• We also reviewed other relevant materials, including laws 

and FDA and Commissioned Corps policies.

9
Enclosure

12 GAO-12-650R FDA Employee Performance Standards

Scope and Methodology

• We conducted our work from March 2012 through April 

2012 in accordance with all sections of GAO’s Quality 

Assurance Framework. The framework requires that we 

plan and perform the engagement to obtain sufficient and 

appropriate evidence to meet our stated objectives and to 

discuss any limitations in our work. We believe that the 

information and data obtained, and the analysis 

conducted, provide a reasonable basis for any findings 

and conclusions in this product.

10
Enclosure

13 GAO-12-650R FDA Employee Performance Standards

11

Background

FDA Medical Product Application Review

• Medical product applications—including new drug and 

device applications—are reviewed by employees in 

CDER, CBER, and CDRH. These staff include executive 

and nonexecutive employees from FDA as well as 

members of the U.S. Public Health Service Commissioned 

Corps stationed at FDA. 

• Not all applications, such as those for generic drugs, are 

subject to user fees and the performance goals 

associated with PDUFA and MDUFA.
Enclosure

14 GAO-12-650R FDA Employee Performance Standards

12

Background

FDA Medical Product Application Review (cont.)

• FDA receives a variety of applications for medical products for 

which the agency is subject to PDUFA or MDUFA performance 

goals. These goals vary based on the type of application, which 

can include

• Applications for new drugs, medical devices, and biologics–such as 

New Drug Applications (NDA), Premarket Approvals (PMA), Premarket 

Notifications (510(k)s), and Biologics License Applications (BLA).

• Applications to modify existing medical products, or supplements to 

modify the use or manufacturing of medical products. 

• Drug applications subject to PDUFA may be reviewed in CDER. 

Device applications subject to MDUFA may be reviewed in 

CDRH. Applications with a biological component that are subject 

to either PDUFA or MDUFA may be reviewed in CBER. 
Enclosure

15 GAO-12-650R FDA Employee Performance Standards

Type of application Performance goal

Priority original NDAs, 

BLAs, and efficacy 

supplements

90% within 6 months of receipt

Standard original 

NDAs, BLAs, and 

efficacy supplements 

90% within 10 months of receipt

Manufacturing 

supplements 

90% within 6 months of receipt 

and those requiring prior approval 

within 4 months of receipt

Class 1 resubmitted 

original NDAs, BLAs, 

and efficacy 

supplements 

90% within 2 months of receipt

Class 2 resubmitted 

original NDAs, BLAs, 

and efficacy 

supplements 

90% within 6 months of receipt

PDUFA Review Performance Goals, 

FY 2008-2012

13

Background 

Goals Associated with PDUFA and MDUFA

Type of application Performance goal

Original PMAs, Panel-Track Supplements, and 

Premarket Reports 

60% within 180 days 

90% within 295 days

Expedited Original PMAs and Panel-Track PMA 

Supplements 

50% within 180 days 

90% within 280 days

PMA Modules 75% within 90 days 

90% within 120 days

180-day PMA Supplements 85% within 180 days 

95% within 210 days

Real-Time PMA Supplements 80% within 60 days 

90% within 90 days

510(k)s 90% within 90 days 

98% within 150 days

MDUFA Review Performance Goals, 

FY 2008-2012

Source: GAO analysis of FDA data. Source: GAO analysis of FDA data.
Enclosure

16 GAO-12-650R FDA Employee Performance Standards

Background 

FDA Employee Performance Assessment

• Most federal agencies’ performance management systems 

are subject to review by the Office of Personnel Management 

(OPM). OPM reviews these systems to ensure they meet 

statutory and regulatory requirements.

• The Department of Health and Human Services (HHS) has 

established a performance management system for its 

component agencies, including FDA. HHS’s system has 

been reviewed by OPM.

• HHS provides FDA with a framework for the agency to develop its 

employees’ performance plans. 

• Centers within FDA develop templates for employee performance 

plans.

14
Enclosure

17 GAO-12-650R FDA Employee Performance Standards

Background 

FDA Employee Performance Assessment (cont.)

• FDA conducts performance assessments of its employees 

on an annual cycle. 

• Staff involved in the review of medical product 

applications—with the exception of the Commissioned 

Corps—develop performance plans with their managers at 

the beginning of a performance cycle, and are assessed 

at the end of a cycle based on the standards in the 

performance plan, depending on whether they are an 

executive employee—such as a Center Director—or a 

nonexecutive employee. 

15
Enclosure

18 GAO-12-650R FDA Employee Performance Standards

Background 

FDA Employee Performance Assessment (cont.)

• FDA’s performance management system is decentralized 

and paper-based. 

• Information, including standards from individual employees’ 

performance plans and their subsequent annual assessments, is 

not stored in a single place or available in electronic format.

• High-level summary information on employee performance may be 

tracked separately by managers within FDA centers using various 

software programs.

16
Enclosure

19 GAO-12-650R FDA Employee Performance Standards

Background 

FDA Employee Performance Assessment: Executives

• Executive employees’ performance plans can contain up 

to seven standards on which executive employees are 

assessed.

• Two of these standards are required for executive employees in 

HHS: (1) Executive Leadership, and (2) Management.

• Up to five of these standards can be customized by their 

supervisors as needed. For example, one performance plan might 

include: Improve the Quality of Medical Devices, Advance a Total 

Life Cycle Approach to Medical Devices, and Advance FDA’s 

Global Product Safety Strategy. Another might include: 

Performance Culture, Supervisory Procedures, Communication, 

and Technical Competency. 

17
Enclosure

20 GAO-12-650R FDA Employee Performance Standards

Background 

FDA Employee Performance Assessment: Nonexecutives

• Nonexecutive employees’ performance plans can have up 

to six standards on which an employee is assessed.

• One of these standards is required for nonexecutive 

employees in HHS: Administrative Requirements.

• Up to five of these standards can be customized by their 

supervisors as needed. For example, one performance plan 

might include: Strategic Direction, Leadership/Motivational 

Skills, and Communication. Another might include: Data 

Analysis and Evaluation, Technical Expertise, Customer 

Service, and Advice.

18
Enclosure

21 GAO-12-650R FDA Employee Performance Standards

Background 

FDA Employee Performance Assessment: Commissioned Corps

• Commissioned Corps officers are not required to have 

performance plans, but some officers may have such 

plans at their supervisors’ discretion. 

19
Enclosure

22 GAO-12-650R FDA Employee Performance Standards

20

Results 

Employee Performance Standards for the Timely Review of 

Medical Product Applications 

• Timeliness One Aspect of Employee Performance 

Assessments

• Timeliness Standards for Center Directors, Other Executive 

Employees, and Nonexecutive Employees

• Timeliness Standards for Commissioned Corps Officers
Enclosure

23 GAO-12-650R FDA Employee Performance Standards

21

FDA Employee Performance Standards 

Timeliness One Aspect of Employee Performance 

Assessments

• FDA officials told us that,

• The timeliness of application reviews is one aspect of employee 

performance, and it is also important to balance timeliness with the 

agency’s standards for medical product safety and effectiveness.

• Assessing employee performance based solely on timeliness is 

inappropriate because, for example, more difficult applications 

could be associated with longer review times.

• Multiple employees are responsible for the review of a single 

application, and it is not any one employee’s responsibility to meet 

the goals related to PDUFA and MDUFA.
Enclosure

24 GAO-12-650R FDA Employee Performance Standards

22

FDA Employee Performance Standards 

Timeliness Standards for Center Directors

• FDA officials told us that the Center Directors in CDER, 

CBER, and CDRH—who are executive employees—are 

ultimately accountable for meeting the timelines related to 

the PDUFA and MDUFA performance goals—including 

the percentages of reviews conducted within designated 

time frames.
Enclosure

25 GAO-12-650R FDA Employee Performance Standards

23

FDA Employee Performance Standards 

Timeliness Standards for Center Directors (cont.)

• Performance plans for two of three Center Directors 

explicitly included timeliness goals related to PDUFA or 

MDUFA. The performance plan for the CDRH Director 

included general language about timeliness.

• Performance plans for all three Center Directors included 

management standards that stated that the employees 

should hold themselves and others “accountable for 

measurable, high-quality, timely, and cost-effective 

results.”
Enclosure

26 GAO-12-650R FDA Employee Performance Standards

24

FDA Employee Performance Standards 

Timeliness Standards for Center Directors (cont.)

• For example, 

• The performance plan for the CDER Director included language 

specific to PDUFA under a standard titled “Advancing Medical Product 

Safety and Effectiveness.” This plan stated that the Director is 

expected to achieve a target of 90 percent completion of standard 

reviews within 10 months, and achieve a target of 90 percent 

completion of priority reviews within 6 months, consistent with PDUFA 

goals.

• The performance plan for the CBER Director included language 

specific to MDUFA and PDUFA under a standard titled “Access to Safe 

and Effective New Products.” The performance plan stated that the 

Director is expected to achieve a target of 90 percent completion of 

standard and priority BLA/NDA reviews within specified time frames 

and to achieve a target of 90 percent completion of 510(k) reviews 

within 90 days. 
Enclosure

27 GAO-12-650R FDA Employee Performance Standards

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FDA Employee Performance Standards 

Timeliness Standards for Other Executive Employees

• Timeliness standards were included in all 18 performance plans 

for other executive employees in CDER, CBER, and CDRH. 

Performance plans for two of these executive employees—one 

from CBER and the other from CDRH—explicitly stated that the 

employees are expected to meet timeliness goals associated 

with PDUFA or MDUFA. 

• The performance plan for the Director of the Office of Compliance and Biologics 

Quality in CBER stated that the employee should “Continue to provide timely 

reviews of applications and supplements, and meetings with industry. Measure: 

Meet PDUFA and MDUFMA goals for reviews and meetings through July 31, 

2012.”

• The performance plan for the Director of the Office of In Vitro Diagnostic Safety 

and Evaluation in CDRH stated that the employee should, “By September 30, 

2012, achieve 90% completion of 510(k)s within 90 days.”
Enclosure

28 GAO-12-650R FDA Employee Performance Standards

26

FDA Employee Performance Standards 

Timeliness Standards for Nonexecutive CDER Employees

• Employee timeliness is mentioned as one part of the 

performance plan templates that CDER provided for all 18 

nonexecutive employee positions involved in the review of 

applications. None of the templates explicitly stated that 

the employees are expected to meet timeliness goals 

associated with PDUFA. However, two templates referred 

to FDA guidance that explicitly mentions these timeliness 

goals. 

• For example, the performance plan template for clinical 

analysts stated that these employees are expected to 

complete evaluations, “in a timely manner, as determined 

by the supervisor.”
Enclosure

29 GAO-12-650R FDA Employee Performance Standards

27

FDA Employee Performance Standards 

Timeliness Standards for Nonexecutive CBER Employees

• Employee timeliness is mentioned in the performance plan 

templates CBER provided for all five nonexecutive 

employee positions involved in the review of applications. 

Two of these templates explicitly stated that the 

employees are expected to meet timeliness goals 

associated with PDUFA or MDUFA. 
Enclosure

30 GAO-12-650R FDA Employee Performance Standards

28

FDA Employee Performance Standards 

Timeliness Standards for Nonexecutive CBER Employees (cont.)

• For example,

• The performance plan template for a research regulator stated that 

this employee should conduct “comprehensive science-based 

reviews of regulatory submissions for products regulated by 

CBER,” and that these reviews “should comply with milestones 

specified in PDUFA, MDUFMA, and Center/Office review 

management procedures.”

• The performance plan template for a nonexecutive manager in 

CBER stated that the manager should provide direction “in 

accomplishing Agency/Center/Office Strategic goals and 

commitments,” and that the manager should convey “a sense of 

urgency” to employees.
Enclosure

31 GAO-12-650R FDA Employee Performance Standards

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FDA Employee Performance Standards 

Timeliness Standards for Nonexecutive CDRH Employees

• Employee timeliness is mentioned in the performance plan 

templates CDRH provided for all six nonexecutive employee 

positions involved in the review of applications. Four of these 

templates explicitly stated that the employees are expected to 

meet timeliness goals associated with MDUFA.

• Language from the MDUFA goals was included in the 

templates for some nonexecutive CDRH employees. The 

pattern in CDRH—with nonexecutive performance plan 

templates citing MDUFA goals, but the Center Director plan 

making no reference to the goal—is in contrast to the pattern 

in CDER, where the Center Director plan mentioned the 

PDUFA goals but the nonexecutive templates did not.
Enclosure

32 GAO-12-650R FDA Employee Performance Standards

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FDA Employee Performance Standards 

Timeliness Standards for Nonexecutive CDRH Employees (cont.)

• For example,

• The performance plan template for a premarket reviewer in CDRH’s 

Office of Device Evaluation stated that a fully successful reviewer 

will complete reviews “within statutory deadlines to meet Office 

goals and MDUFA goals.”

• The performance plan template for a manager in CDRH’s Office of 

Device Evaluation stated that a fully successful manager “informs 

and motivates staff to meet established MDUFA goals for assigned 

documents.”
Enclosure

33 GAO-12-650R FDA Employee Performance Standards

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FDA Employee Performance Standards 

Timeliness Standards for Commissioned Corps Officers

• Commissioned Corps officers—who are not required to use 

performance plans—are assessed based on eight standards.

• These eight standards are: Leadership; Initiative and Growth; 

Communication Skills; Interpersonal Skills; Planning and Organization; 

Professional Competencies; Analysis, Judgment, and Decision-making; 

and Overall Effectiveness. 

• Supervisors consider officers’ specific duties and responsibilities when 

assessing them based on these eight standards. 

• Because all Corps officers are assessed on these eight 

standards regardless of where they are stationed, the standards 

do not include timeliness goals related to PDUFA and MDUFA. 

However, the Planning and Organization standard does include 

a general mention of timeliness. 
Enclosure

34 GAO-12-650R FDA Employee Performance Standards

32

Agency Comments

• To obtain agency comments, we provided a draft of these 

briefing slides to FDA and discussed the draft with agency 

officials. FDA provided oral and e-mail comments. 

• The agency generally agreed with the information 

presented in the draft and also provided technical 

comments, which we incorporated as appropriate.

(291030)
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