News Release

Statement by Mike Leavitt
Secretary of Health and Human Services,
On the Institute of Medicine Report on the Future of Drug Safety

I commend the Institute of Medicine (IOM) for their thorough report, �The Future of Drug Safety,� which provides an important appraisal of the Food and Drug Administration�s (FDA) recent efforts to improve the safety and effective use of prescription drugs in the United States. In its report the IOM recognized the significant progress FDA has made in improving its management and communications about the drug safety review process.

Admittedly, there is a tension between balancing the risks and benefits of innovative new treatments for patients in need of hope. All drugs have risks associated with them. We must balance those risks against the need to efficiently get new innovations to patients who can benefit from them. We can minimize these risks while still pursuing necessary new technologies through innovations such as FDA�s Critical Path Initiative that enable smarter and more personalized medicine so we can target new drugs more effectively.

There are two steps that can be taken quickly and that will have a dramatic positive impact on our ability to further enhance our drug safety efforts.

First, I call on the Senate to quickly confirm Dr. Andrew von Eschenbach as FDA commissioner. The FDA needs permanent leadership, and Dr. von Eschenbach has the energy, the vision and the support to bring our drug safety review process into the 21st Century. We have excellent and dedicated scientists at FDA and they work hard to make wise and prudent decisions about the safety and effectiveness of drugs. Their high quality work has made the FDA an icon of trust, a certifier of safety, an enabler of innovation and a repository of information. But retaining that noble status requires permanent leadership at the agency. Today�s report further underscores the need for swift Senate action.

Secondly, Congress must ensure that health information technology legislation support and emphasize the importance of interoperable health records. The interoperability of health records is an essential element to our efforts to improve drug safety and create value in health care. Without the ability to ensure interoperability of electronic medical records, we will lose many opportunities to improve drug safety through the use of health information technology.

The future of improved drug safety and value in health care relies on a drug regulation process that keeps pace with advances in technology and science. I look forward to working with Congress and my colleagues at the FDA to make that happen.

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Last revised: September 22, 2006