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FOR IMMEDIATE RELEASE |
Media Inquiries: |
The FDA appreciates the work of the Institute of Medicine (IOM) for this report. The study was commissioned and supported by FDA and the IOM committee has provided substantive recommendations on how the FDA can continue to improve our approach to ensure the safe and effective use of prescription drugs. While considerable work has been done over the past two years to improve our approach to drug safety, work still remains to be done. As the science of drug development continues to evolve we must constantly improve the approach to drug regulation to ensure that care providers and patients can make optimal decisions about the medicines they use to improve their health.
As the IOM report recognizes, much progress and reform of FDA's safety oversight enterprise is already underway. Specifically, the FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues. All drugs have risks. Our challenge is to uncover these risks as soon as possible. Through initiatives like Critical Path and Personalized Medicine, we are also working to improve the tools we use, to more effectively evaluate new products and processes.
I am committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine, to ensure we continue to fulfill our mission. Over the next months you will be hearing extensively from us about these new endeavors, including a number of initiatives aimed at improving the opportunities for employees of FDA to shape a more effective work environment.
FDA has much to look forward to as it leads our nation and partners with counterpart agencies to lead the world through a time of radical change in creating health and eliminating disease. We derive our value as a health regulatory authority from the quality of our scientific and professional discourse and decisions. Above all, we recognize a need to mindfully acknowledge any weaknesses in our organization's process, or infrastructure or culture and then aggressively design and adopt programs to strengthen the FDA enterprise.
With regards to strengthening FDA let me take a moment to recognize the dedicated staff who serves at FDA. I'd like to specifically commend the staff of the Center for Drug Evaluation and Research for the important role they play and job they do each and every day. Across the entire FDA these dedicated public servants are, and will always be, this nation's greatest asset.
Even serving as acting Commissioner of FDA, it is apparent to me my role and the FDA's role has always been and will always be -- no matter how much we change over time -- to cherish the trust of patients and the public. Every single action, decision or activity must be directed to preserving their lives and protecting their health. This is more than just a contract with the public to provide a list of services or regulatory functions but rather it is a covenant with the patients and the people we serve to protect and promote their health and to achieve our mission we will evaluate the report and take necessary steps.
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