Friends of Cancer Research is coordinating an ongoing educational and awareness project focused on opportunities for organizational improvements at the FDA regarding the review of cancer-specific products.  This initiative is designed to work collaboratively with multiple stakeholders from government, industry, academia, and NGOs to promote more efficient and consistent processes at the FDA for the handling of oncology products. 

For over three years, Friends of Cancer Research has been working alongside and in concert with top cancer research scientists, advocacy leaders and professional society directors to promote more efficient and consistent processes at the FDA for the handling of oncology products.  To assist us in exploring and explaining the scientific merits of this effort, we organized a working group of highly respected cancer experts in 2003 who helped identify problems and solutions regarding the FDA’s review process.  

In 2006, Friends again organized an expert working group to address recent issues surrounding drug safety and efficacy.  The group, chaired by Dr. Robert Young, former President Fox Chase Cancer Center, released a white paper report titled "Drug Safety and Drug Efficacy: Two Sides of the Same Coin" in early 2007.  For more information, please visit the paper's website at: www.focr.org/drugsafetyreport.htm

Our collaborative efforts on this issue played a key role in supporting the creation of a new Office of Oncology Products at FDA, which was announced on July 16^th of 2004 by HHS Secretary Tommy Thompson.  The purpose of this new office is to help streamline the review process by consolidating into a single administrative entity the authority over an array of biologics, drugs and imaging technologies with cancer indications. Similar to the other drug evaluation offices (typically referred to as ODEs) in the Center for Drug Evaluation and Review, this office will be housed within the Office of New Drugs.  The FDA’s proposed changes will consolidate much of CDER’s review authority over cancer products into a single office dedicated entirely to oncology.  As a subset of the office, the FDA is creating an “Oncology Program” designed to help coordinate cancer-related activities throughout the agency such as regulatory policy and cross-agency consultations.

However, much work remains to be done.  We believe that thoughtful analysis and dialogue about structural opportunities at the FDA for further consolidating the review of oncology applications will continue to help streamline the development, evaluation, and delivery of new oncology products.