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Commentary

Streamlining Drug Approval
Peter J. Pitts, Robert Goldberg, Ph.D., Robert Peter Gale, Washington Times, 6-22-06

Pitts and Goldberg, co-founder of the Center for Medicine in the Public Interest offer this perspective on Congressional efforts to "improve" drug safety at the FDA:

By the time you are finished reading this article, 10 people will have died of cancer and seven people will have been diagnosed with Alzheimer‘s disease. Meanwhile, the FDA has approved the lowest number of new medicines in memory, and the success rate of drugs making it from the lab to patients has declined from 12 percent to 8 percent despite an increase in spending on drug development. At current rates—and the number of people diagnosed with Alzheimer‘s will double in 20 years—these two illnesses will cost patients‘ families, and the nation, $500 billion a year.

You would think that Congress would welcome an effort to close the gap between the development process and the promise of unprecedented progress against disease that advanced technologies such as genomics offer. Think again. Many members of Congress are pushing a battle plan to expand the regulatory reach of the FDA rather than waging a war against infectious diseases, Alzheimer‘s, cancer and other illnesses.

Worst of all, politics—not science or suffering—is playing the lead role in this controversy. Some want another level of control—an independent Drug Safety Board that could intervene and demand additional safety studies of any size and quantity at virtually any time before, or after, approval.

Others want the FDA to have the power to demand additional clinical trials of any size and duration to ferret out possible safety problems and to yank drugs off the market, regardless of their benefit, if the studies are not completed within a specific time frame. Certainly, this would make the approval process far less efficient and limit a patient‘s access to new life-saving developments. But would it at least improve drug safety? Unfortunately, the answer is no.

It‘s simply not true that more studies make safer medicines. Over the past 40 years, the percent of medicines withdrawn from the market because of dangerous side effects has been essentially constant at about 2 or 3 percent, even as the number of required clinical studies—a current average of 120 per drug approval—has mushroomed.



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