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Commentary

FDA Announces New Steps to Improve Drug Safety
Dr. Scott Gottlieb, U.S. Food and Drug Administration, 11-13-06

On November 13, Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the FDA, spoke at a Manhattan Institute forum in New York City on the issue of drug safety. His remarks are well worth reading in their entirety.

As you know, issues relating to the safety of new medical products, and in particular new drugs, have been at the forefront of recent policy making at FDA and discussion inside Washington. These issues are likely to be front and center when the new Congress convenes next year. This focus follows a string of some high profile drug recalls and safety alerts, and more recently, the release of a report from the Institute of Medicine (IOM) that was commissioned by FDA to take a hard, objective look at the agency's drug safety programs. While the IOM report reaffirmed the competency of FDA's central programs, it also found that there are some more steps that we could be taking to continue to improve our ability to detect and monitor safety–related issues with new medicines. At FDA, we agree. It is these efforts, and some of the challenges we face when it comes to taking steps to improve the safe use of life saving medical products, that I want to discus here today.

I think the findings made by the IOM mirror our own judgments at FDA, and the report's recommendations track closely to where we have been spending much of our time in trying to improve our existing programs. I know that the IOM report, and the high–profile recalls over the last several years as well as the newly–emerging safety questions with a handful of drugs, have all called into question among some people whether FDA is doing enough to make sure that drug safety issues are taking a high priority in the development process and during our review process. The truth is we are doing an awful lot, but we know there are steps we can take to do even more, to make sure we have a robust and well–resourced drug safety program.

The bottom line is this: New drugs and devices and diagnostics present the greatest opportunity currently available to improve health care and the way medicine is practiced—in other words—the known benefits of innovative new therapies—from improved patient outcomes to reduced longer term health care costs—these known benefits outweigh virtually all known risks whether its advances in the treatment of heart disease to cancer to diabetes. The number of lives saved and prolonged by new therapies vastly outweighs the risks that the treatments themselves pose, by any logical accounting.

It's the responsibility of all of us engaged in the healthcare enterprise, and especially those of us making policy decisions in Washington where many are removed from the daily struggles faced by patients and doctors and therefore apt to make bad decisions, to make sure that we find ways to make more of these breakthroughs a reality through appropriate incentives to innovate, and to ensure that patients who are suffering with little or no available treatment options get access to these life extending and quality of life improving medicines as early as possible.

But it is also true and we must recognize that all drugs pose potential risks. An active molecule that impedes one biological pathway to help cure or mitigate an illness will inevitably inhibit other pathways that are at the route of normal biology. It is almost inevitable that unwanted side effects, and often very subtle or rare side effects, could be the result. Our challenge is to have systems to unearth these side effects early after new drugs are launched, or during the development process itself. Then we need to make sure we have efficient tools to get information about these potential problems to practitioners and patients so they can make informed, personal decisions about the medical products they use. People need reliable, timely information about drugs so that the can most appropriately balance the risks and benefits of a treatment of their particular health problems.



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