oversight

Food and Drug Administration: Employee Performance Standards for the Timely Review of Medical Product Applications

Published by the Government Accountability Office on 2012-04-18.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

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.




                                                 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




2                                   GAO-12-650R FDA Employee Performance Standards
Enclosure




      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
                                                                                    1




3                                           GAO-12-650R FDA Employee Performance Standards
Enclosure




      Overview

       •    Introduction
       •    Objective
       •    Scope and Methodology
       •    Background
       •    Results
       •    Agency Comments




                                                                            2




4                                   GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.

                                                                                                                                3




5                                                                  GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.
                                                                          4




6                                 GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.

                                                                           5




7                                  GAO-12-650R FDA Employee Performance Standards
Enclosure




      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).

                                                                                                                             6




8                                                             GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.




                                                                         7




9                                GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.
                                                                           8




10                                 GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




11                                 GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




12                                GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.



                                                                          11




13                                 GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.
                                                                                    12




14                                        GAO-12-650R FDA Employee Performance Standards
Enclosure




      Background
      Goals Associated with PDUFA and MDUFA

            PDUFA Review Performance Goals,                                  MDUFA Review Performance Goals,
            FY 2008-2012                                                     FY 2008-2012
            Type of application       Performance goal                      Type of application                           Performance goal

            Priority original NDAs,   90% within 6 months of receipt        Original PMAs, Panel-Track Supplements, and   60% within 180 days
            BLAs, and efficacy                                              Premarket Reports                             90% within 295 days
            supplements
            Standard original         90% within 10 months of receipt       Expedited Original PMAs and Panel-Track PMA   50% within 180 days
            NDAs, BLAs, and                                                 Supplements                                   90% within 280 days
            efficacy supplements
            Manufacturing             90% within 6 months of receipt        PMA Modules                                   75% within 90 days
            supplements               and those requiring prior approval                                                  90% within 120 days
                                      within 4 months of receipt
                                                                            180-day PMA Supplements                       85% within 180 days
            Class 1 resubmitted       90% within 2 months of receipt                                                      95% within 210 days
            original NDAs, BLAs,
            and efficacy                                                    Real-Time PMA Supplements                     80% within 60 days
            supplements                                                                                                   90% within 90 days
            Class 2 resubmitted       90% within 6 months of receipt
            original NDAs, BLAs,
                                                                            510(k)s                                       90% within 90 days
            and efficacy
                                                                                                                          98% within 150 days
            supplements



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




                                                                                                                                                13




15                                                                         GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




16                                     GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




17                               GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




18                                      GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




19                                      GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




20                                    GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




21                               GAO-12-650R FDA Employee Performance Standards
Enclosure




      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




                                                                             20




22                                    GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.



                                                                                     21




23                                       GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.




                                                                           22




24                                  GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.”



                                                                            23




25                                   GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.
                                                                                      24




26                                        GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.”
                                                                                                    25




27                                              GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.”
                                                                         26




28                                GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.




                                                                         27




29                                GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.

                                                                               28




30                                      GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.
                                                                              29




31                                     GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.”




                                                                                30




32                                      GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.
                                                                                         31




33                                         GAO-12-650R FDA Employee Performance Standards
Enclosure




      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.




                                                                         32




(291030)



34                                GAO-12-650R FDA Employee Performance Standards
This is a work of the U.S. government and is not subject to copyright protection in the
United States. The published product may be reproduced and distributed in its entirety
without further permission from GAO. However, because this work may contain
copyrighted images or other material, permission from the copyright holder may be
necessary if you wish to reproduce this material separately.
                      The Government Accountability Office, the audit, evaluation, and
GAO’s Mission         investigative arm of Congress, exists to support Congress in meeting its
                      constitutional responsibilities and to help improve the performance and
                      accountability of the federal government for the American people. GAO
                      examines the use of public funds; evaluates federal programs and
                      policies; and provides analyses, recommendations, and other assistance
                      to help Congress make informed oversight, policy, and funding decisions.
                      GAO’s commitment to good government is reflected in its core values of
                      accountability, integrity, and reliability.

                      The fastest and easiest way to obtain copies of GAO documents at no
Obtaining Copies of   cost is through GAO’s website (www.gao.gov). Each weekday afternoon,
GAO Reports and       GAO posts on its website newly released reports, testimony, and
                      correspondence. To have GAO e-mail you a list of newly posted products,
Testimony             go to www.gao.gov and select “E-mail Updates.”

Order by Phone        The price of each GAO publication reflects GAO’s actual cost of
                      production and distribution and depends on the number of pages in the
                      publication and whether the publication is printed in color or black and
                      white. Pricing and ordering information is posted on GAO’s website,
                      http://www.gao.gov/ordering.htm.
                      Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
                      TDD (202) 512-2537.
                      Orders may be paid for using American Express, Discover Card,
                      MasterCard, Visa, check, or money order. Call for additional information.
                      Connect with GAO on Facebook, Flickr, Twitter, and YouTube.
Connect with GAO      Subscribe to our RSS Feeds or E-mail Updates. Listen to our Podcasts.
                      Visit GAO on the web at www.gao.gov.
                      Contact:
To Report Fraud,
Waste, and Abuse in   Website: www.gao.gov/fraudnet/fraudnet.htm
                      E-mail: fraudnet@gao.gov
Federal Programs      Automated answering system: (800) 424-5454 or (202) 512-7470

                      Katherine Siggerud, Managing Director, siggerudk@gao.gov, (202) 512-
Congressional         4400, U.S. Government Accountability Office, 441 G Street NW, Room
Relations             7125, Washington, DC 20548

                      Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800
Public Affairs        U.S. Government Accountability Office, 441 G Street NW, Room 7149
                      Washington, DC 20548




                        Please Print on Recycled Paper.