Friends of Cancer Research presents the following special cancer policy alert on an issue of importance to the cancer and medical research communities.

Friends of Cancer Research presents the following special cancer policy alert on an issue of importance to the cancer and medical research communities.

FDA Issues Response to IOM Report
Response addresses science, communication, and operations

Washington D.C. - Today, January 30, 2007, the Food and Drug Administration (FDA) issued a formal response to the Institute of Medicine’s (IOM) September 2006 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public.

The 2006 IOM Report presented recommendations to improve risk assessment, surveillance, and safe use of approved drugs. After a great deal of review of the IOM recommendations, the FDA's response today addresses three themes: strengthening the science that supports our drug product safety system, improving communication and information flows, and improving operations and management.

Additionally, the response includes descriptions of new or recently initiated programs that are designed to address the recommendations. New programs include a proposed public-private supported communication network to effectively disseminate emerging adverse drug reaction information, a pilot program to systematically and collaboratively review the safety profile of new molecular products on a regular basis, as well as initiatives to improve internal communication and the use of FDA advisory committees. Other initiatives include data sharing collaborations with the Veterans Health Administration and Center for Medicare and Medicaid Services, as well as a number of new programs to enhance the scientific foundation of FDA product analysis, approval, and surveillance.

Friends Chair, Dr. Ellen Sigal commented on the FDA’s response saying, “We must be sure that FDA has the proper resources and personnel to fully integrate the science and technology that will ultimately lead to a systematic approach to safety surveillance.” Dr. Sigal additionally emphasized, “It is our utmost concern that upcoming legislation not only improves drug safety, but also allows responsible new drug access to patients and ensures that the innovative product development pipeline continues to grow.”

Similarly related, on January 16, 2007 the proposed agreement for the fourth reauthorization of the Prescription Drug User Fee Act (PDUFA) was announced. The renewal of this legislation will provide essential funding for the agency and includes enhancements to the current drug safety infrastructure. The agreement contains elements that appear in the IOM recommendations such as additional employees, identifying new surveillance methods, as well as developing scientific guidance documents to provide improved models for product development.

For more information and the FDA's full response to the IOM Report, please visit the FDA's website for the official press release.

For any other questions, please contact Friends Director of Science Policy, Dr. Jeff Allen at jallen@focr.org

 

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Over the past ten years, Friends of Cancer Research (Friends), a 501 (c)(3) non-profit, has pioneered innovative public-private partnerships, organized critical policy forums, educated the public, and brought together key communities to develop collaborative strategies in the field of cancer research.  Through these efforts, Friends continues its mission in raising awareness on the importance of cancer research to accelerate the progress toward better tools for the prevention, detection, and treatment of all cancers.