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

What GAO Found

Employee Performance Standards for the Timely Review of Medical Product Applications:

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 the Prescription Drug User Fee Amendments (PDUFA) and the Medical Device User Fee Amendments (MDUFA).

Timeliness Standards for Center Directors, Other Executive Employees, and Nonexecutive Employees:

• FDA officials told us that the Center Directors in 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)—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.

• 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.”

• 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.

• 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.

• 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.

• 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.

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.

• 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.

Why GAO Did This Study

This report responds to the congressional request that we provide information on the standards that the Food and Drug Administration (FDA) considers when assessing the performance of its employees. Congress 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.

For more information, contact Marcia Crosse at (202) 512- 7114 or crossem@gao.gov.