Team Biologics
On July 30, 1997, Michael Friedman, Lead Deputy Commissioner of the Food and Drug Administration (FDA), approved the establishment of Team Biologics after an internal National Performance Review assessment of policies, operations, and training plans related to FDA's regulation of biological products, as well as concerns raised in oversight reviews by the General Accounting Office, the Institute of Medicine, HHS Inspector General (including Review of the FDA Inspection Process of Plasma Fractionators June 1997), and Congress.
The goal of Team Biologics is to assure the quality and safety of biological products. To accomplish this, a group of specialized investigators has been formed to inspect licensed biological drug and device product facilities regulated by the Center for Biologics Evaluation and Research (CBER). These specialized investigators (the Core Team) have access to a similarly specialized group of compliance officers for guidance, support and counsel on evidence development and assistance in drafting any required administrative or regulatory action documents.
The partnership between CBER and the Office of Regulatory Affairs (ORA) has been highly successful in utilizing the diverse skills and knowledge of both ORA and CBER staffs to focus resources on inspectional and compliance issues in the biologics area. The goal of Team Biologics continues to focus on ensuring the quality and safety of biologic products and to quickly resolve inconsistencies.
Oversight of Team Biologics activities is maintained by the Team Biologics Operations Group (Operations Group). The Operations Group membership includes senior managers from CBER and ORA. A prime objective of the Operations Group is to establish procedures and promote development of policy to be implemented by the Core Team. The Operations Group serves as the focal point for CBER and ORA by providing a mechanism for policy resolution and a forum for discussion of regulatory issues.
In January 2001, the Operations Group convened an Evaluation Workgroup composed of members from CBER, ORA, and the Office of Planning and Legislation (OPL) to evaluate the effectiveness of Team Biologics. The convened Evaluation Workgroup submitted its final report in October 2002, which contained 28 options for Agency consideration. In response to the issues raised by the Evaluation Workgroup, the Operations Group established eight work groups to assess and, where appropriate, address operational issues and improvements to the operations of Team Biologics. These activities are continuing under the direction of the Operations Group and, in addition, are an element in the Agency's overall efforts under the new initiative "Pharmaceutical CGMPs for the 21"; Century: A Risk-Basked Approach." Changes implemented as a result of the evaluation include:
- Implementation of a Quality Management System
- Creation of metrics to evaluate performance
- Risk-based work planning
- Standardized training/qualifications for members
On June 30, 2003, responsibility for the regulation of certain biologic therapeutic products was transferred from CBER to the Center for Drug Evaluation and Research (CDER) . While these products initially continued to be encompassed by Team Biologics, they were removed from the Team Biologics program in October 2007 and are now inspected by FDA district offices.