Prescription Drugs and the FDA

August 22, 2000

It's an election year and politicians are talking about the cost of prescription drugs. Some are even talking about offering free prescription drugs for Medicare recipients. But if we want to reduce the cost of drugs, maybe we should begin talking about reforming the Food and Drug Administration.

The United States drug companies discover almost half the new drugs in the world. And Americans have been the beneficiaries of these new drugs. New heart medicines, for example, have contributed to the 74 percent drop in cardiac deaths.

But this kind of success has come at a price. Due to FDA requirements, the average costs of developing a new drug is about $650 million. American drug companies invest $24 billion annually in research and development. It takes 12-15 years to discover and develop a new medicine. Only one in 5,000 chemicals looked at in the laboratory ever gets to market. Once approved by the FDA, only 3 in 10 return more than the development costs.

FDA reformers are beginning to suggest that the Food and Drug Administration be limited to monitoring the safety of a drug. That would cost approximately $50 million per drug. The remaining $600 million in development costs for a new drug is spent on clinical human efficacy trials. And these trials add a four-year to eight-year delay in the release of the drug.

Reformers suggest that patients and doctors determine a drug's efficacy. In other words, let the free market work and eliminate an enormous part of the governmental bureaucracy. It's an interesting concept. Let the FDA continue to monitor safety, but get the drugs to market earlier and let the free market determine how effective it might be. So maybe the best way to reduce the cost of prescription drugs is to reduce the scope of the FDA.

I'm Kerby Anderson of Probe Ministries, and that's my opinion.