Washington Editor
WASHINGTON - Since taking over the leadership post at the FDA, Commissioner Mark McClellan has made a fair number of changes, most of which center on running a more efficient operation.
Speeding drug approvals, by way of opening lines of communication with companies to prevent mistakes in clinical trials and the application process, appears to be at the heart of McClellan's new FDA.
And now, McClellan and Andrew von Eschenbach, director of the National Cancer Institute of the National Institutes of Health, will assign senior staff to a joint task force charged with streamlining development of new cancer drugs and speeding their delivery to patients.
Details of the task force were scheduled to be released this week at a meeting of the American Society of Clinical Oncology in Chicago.
Nancy Roach, director of the Marti Nelson Cancer Foundation in Vacaville, Calif., who attended the meeting in Chicago, told BioWorld Today the collaboration appears to be a positive step, especially if it means better drugs will get to patients faster. "And as a taxpayer, I love seeing cooperation between agencies," she said.
In a prepared statement, McClellan said, "At a time when the opportunities to reduce the burden of cancer are greater than ever, sharing tools and resources with our colleagues at the NCI will help us fulfill that mission."
And Elias Zerhouni, director of the NIH, said in a prepared statement that the effort between the FDA and NCI could serve as a prototype for other areas of research.
So, how will this task force of senior government officials help a biotech company looking to make it in the cancer arena?
Well, in the first place, one of its goals is to develop biomarkers (markers of clinical benefit) for cancer drugs. The task force will devise a standard approach for evaluating biomarkers to demonstrate a drug's clinical effectiveness and usefulness as surrogate endpoints, which are substitutes for more conventional measures such as survival time or progression, a combined statement from the NCI and FDA said.
The task force also will be responsible for:
• Creating a cancer bioinformatics infrastructure to improve data collection and analysis for preclinical, preapproval and postapproval research.
• Addressing joint technology issues. For example, the NCI and FDA staffs currently are working on a clinical proteomics collaboration that could be used as a model for initiatives in areas such as diagnostic imaging and molecular targeting.
• Advancing the development and evaluation process for cancer chemoprevention agents, including the development of clinically meaningful endpoints.
• Reviewing current policies to determine if there are other ways collaborations between FDA and NCI can improve the development and regulatory process of cancer technologies.
Anna Barker, the NCI's deputy director for strategic scientific initiatives and co-chair of the task force, released a prepared statement referring to the task force as a unique opportunity to improve the development process for new cancer drugs and diagnostics. "Whether you're in academia or industry or government, bridging the gaps between research and regulatory processes will benefit everyone involved, especially cancer patients," she said.
Similar Names Targeted As Culprit In Errors
Drug names that look and sound alike may be contributing to medication errors, the FDA said.
Reducing the potential for medication mix-ups due to proprietary name confusion is part of the FDA's ongoing medical product risk management effort.
Along with the Pharmaceutical Research and Manufacturers Association, the FDA will sponsor a meeting in Washington June 26 to hear recommendations on ways of reducing errors attributed to similarities in names. The meeting will be held at the Renaissance Washington D.C. Hotel. For more information visit the FDA's website at http://www.fda.gov/ohrms/dockets or contact Mary Gross, Office of Drug Safety, Center for Drug Evaluation and Research.
