Regulatory Science Initiative Will Prepare FDA for New Technologies
On October 6, FDA Commissioner Dr. Margaret Hamburg released a report that outlines plans to modernize the agency’s product safety review and approval procedures through its Regulatory Science Initiative.
The report notes that recent breakthroughs in science and technology, including the mapping of the human genome and applications of nanotechnology, “have the potential to transform our ability to prevent, diagnose, and treat disease.” The FDA’s regulatory procedures have not kept pace with new scientific developments, the report continues, and the agency’s initiative seeks to address that gap by advancing “regulatory science to develop new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.”
The President’s FY 2011 budget request would provide the FDA with $25 million for the initiative to “expand ongoing efforts within the agency and build additional partnerships with academia, industry, and government agencies,” the report says.
As an example of such partnerships, NIH and the FDA recently announced joint awards to advance regulatory science through four research projects. NIH will contribute $9.4 million over 3 years to the projects, while the FDA will provide $950,000. “These projects show the potential breadth of opportunity that comes from advancing regulatory science,” Dr. Hamburg said. “The results are likely to have broad application to researchers across scientific disciplines and will result in better-informed regulatory decision-making and faster drug development and approval processes.”
Warning about Carboplatin Dosing for Physicians and Principal Investigators
Based on recommendations from NCI’s Cancer Therapy Evaluation Program (CTEP), the FDA sent a communication October 8 to the U.S. oncology community warning of recent changes in the methods of measuring serum creatinine that may affect the dosing of carboplatin cancer therapy.
The new standardized Isotope Dilution Mass Spectrometry (IDMS) method, which all U.S. clinical diagnostic laboratories will use by the end of 2010 to measure the metabolic marker creatinine in blood serum, appears to underestimate creatinine at low levels (e.g., ~0.7 mg/dL) compared with older methods. This discrepancy could result in an overestimation of kidney function and lead to inappropriate dosing of carboplatin.
Thus, the notice states: “If a patient’s [glomerular filtration rate] is estimated based on serum creatinine measurements by the IDMS method, [the] FDA recommends that physicians consider capping the dose of carboplatin for desired exposure….”
The notice provides guidance on how to determine the maximum dose and adds that principal investigators of ongoing clinical trials that involve carboplatin should determine whether the dosing in those trials needs to be adjusted based on the new information.