How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs).
In an advanced posting of an 18 June Federal Register notice, FDA said it had received, and intends to accept, a grant application from the University of Texas Medical Branch (UTMB) Galveston National Laboratory (GNL) to develop the GLP training course.
While GLPs cover a broad range of laboratories, FDA said this particular program is aimed at environments meeting the criteria of Biosafety Level (BSL) 4 laboratories, which contain the most virulent, contagious or dangerous strains of bacterium or viruses and are governed by strict and extensive safety requirements.
In a statement, FDA said it "seeks to support an effort to design a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives."
The agency wants to develop the program as a result of the 'Animal Rule' regulations it developed shortly after anthrax spores were sent through the US postal system in 2001, necessitating the development of medical countermeasures.
The development of medical countermeasures raised ethical issues, as testing a vaccine or drug's clinical safety and efficacy on humans would likely harm-or kill-a portion of those undergoing clinical testing. To work around this problem, FDA said it would accept efficacy studies conducted in human analogues and use those to support limited product approvals.
This, however, raised problems as well, said FDA in the Federal Register posting. Testing the compounds in laboratories poses "daunting challenges to a researcher's ability to meet the requirements of GLP regulations," said FDA.
"To date, there is not a single facility that is capable of performing pivotal studies under GLP at BSL-4," explained FDA. "TO break the current choke point in the development process for interventions against agents requiring maximum containment, it will be critical for laboratories with BSL-4 capacity to receive the training and develop the capability necessary to routinely perform pivotal studies in accordance with GLP."
UTMB will specifically develop training programs for natural history studies investigating proper dosing and animal efficacy studies, said FDA.
The program is scheduled to begin by September 2012, and will be coordinated through FDA's Office of Counterterrorism and Emerging Threats (OCET), acting under FDA's Medical Countermeasures Initiative program.
FDA - Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments