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Greenwood Releases Statement on IOM Drug Safety Document


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Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), has issued the following statement in initial response to release of "The Future of Drug Safety: Promoting and Protecting the Health of the Public," a report written by the Institute of Medicine Committee on the Assessment of the U.S. Drug Safety System:

"The U.S. drug safety system continues to be the 'gold standard' for the world."

"Even so, we support consideration of efforts to further strengthen the system through increased Congressional funding and the development of new tools to improve drug safety."

"We are committed to working with other stakeholders to assist FDA in enhancing its capacity to ensure the safety and effectiveness of marketed biopharmaceuticals and therapies."

Pharmacogenomics research may help identify early in development which potential products will present safety issues.

Better animal models, improved computer-based models, and new clinical evaluation techniques also are evolving.

The FDA's Critical Path Initiative holds promise for ensuring these tools are applied in product development and regulatory processes.

Through the Critical Path Initiative, the FDA is also advancing the development of Personalized Medicine, which allows therapy to be tailored to the individual patient.

For example, Critical Path projects will further the development of biomarkers that help scientists and physicians monitor the progress of disease and evaluate which product will work best for a particular patient. That is why BIO has supported fully funding the Critical Path Initiative.

"Modernization of the medical product development sciences through the Critical Path Initiative will employ new fields of science such as genomics, proteomics and related disciplines, to improve scientific understanding and prevention of safety problems, and will create new opportunities to improve product safety by strengthening post-market surveillance of adverse events," Greenwood said.

Greenwood added that BIO also supports FDA's establishment of the Drug Safety Oversight Board (DSB).

The DSB provides oversight and advice to leadership of the Center for Drug Evaluation and Research on managing drug safety issues and the flow of emerging safety information to healthcare professionals and patients.

"Over the past two years, the Drug Safety Oversight Board has conducted timely and comprehensive evaluations of drug safety concerns and assisted the FDA in ensuring that safe and effective drugs are available for patients," he said.

"BIO values patient safety above all other priorities. When considering enhancements to the U.S. system, we must be cognizant that implementing undue hurdles in the drug review process will harm patients by delaying access to life-enhancing and life-saving products," Greenwood said.

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