April 16, 2008 | FDA has been busy of late. Last week, Commissioner Andrew von Eschenbach announced the appointment of Frank M. Torti, Principal Deputy Commissioner and first Chief Scientist. This is a newly created position resulted from the Food and Drug Administration Amendments Act of 2007.
“As Chief Scientist and a member of the agency's senior leadership team, Dr. Torti will support the launch of the FDA Fellowship Program, which has the potential to attract up to 2,000 professionals of varying disciplines for a two year training program,” according to the FDA statement. “As well, the new office will work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials that are a part of the foundation of the FDA's regulatory structure.”
Torti currently a Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, N.C. He received his bachelor's and master's from Johns Hopkins University, his medical degree from Harvard Medical School. He also serves on the NIH National Advisory Council for Complementary and Alternative Medicine and founded and serves as President of the Cancer Biology Training Consortium, a national society of cancer biology department chairs and program directors. Torti will join the FDA in May.
In related news, FDA has released its draft, “Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan.” FDA says it will focus on hiring needed staff through fiscal year 2009. It will increase the number of risk-management experts responsible for reviewing proposed and implemented Risk Minimization Action Plans or Risk Evaluation and Mitigation Strategies (REMS). Under the PDUFA IV program, the agency will get $29.29 million annually plus a yearly inflation factor to increase its drug-safety capabilities. The draft plan is available here.
Separately, FDA released new guidance for pharmacogenomics – “E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories.” Here’s an excerpt: “In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the International Conference on Harmonisation (ICH). This guidance on definitions is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.” The guidance is available here.