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Development times, about 4-1/2 years long, were stable for the two decades prior to the 1962 Kefauver-Harris Amendments. Since then, development times have soared.

Development times, about 4-1/2 years long, were stable for the two decades prior to the 1962 Kefauver-Harris Amendments. Since then, development times have soared. By the 1990s, the average drug spent over 14 years in regulation-mandated testing and FDA review.

R&D outlays have increased somewhat more rapidly than development times, as manufacturers try to com-press time lines to preserve patent life. What we spend for prescription drugs can be predicted by what manufacturers spend on R&D, Dr. Ruwart explains. If pre-amendment trends had continued, drug prices would be about 15% of what they are today. We'sd have more innovation and twice as many drugs to choose from. Pharmaceuticals replace more expensive medical interventions like surgery, so that every dollar we spend on drugs lowers health care costs by $2-$3.

Do we need more pharmaceuticals when so many are me-too drugs? Excess regulation discourages inno-vation and encourages copy-cats by forcing manufacturers to shift R&D spending from research to develop-ment, Dr. Ruwart points out. We'sd reverse this trend, at least in part, by eliminating excess regulation.

But don'st regulations protect Americans from unsafe drugs? These particular regulations, the 1962 amend-ments, have proven to be more deadly than all of the drug toxicity that occurred before their passage, Dr. Ruwart claims. She estimates that between 1963 and 1999, 4.7 million people died prematurely while the medicine which could have saved them languished in mandated testing. The amendments saved a few thousand lives, but the cost was letting millions die waiting for treatment. That's why the amendments are excess's regulation, Dr. Ruwart explains.

Should those upset about high pharmaceutical prices and development delays blame the FDA? Dr. Ruwart doesn'st think so. The FDA was told to enforce bad law, she points out. The good people there, some of whom I'sve worked with, were put in a very difficult situation.

Before we are regulators, legislators, members of the pharmaceutical industry, or cost-conscious consumers, we are all human beings who will one day need a life-saving medication or medical procedure, Dr. Ruwart contends. For all of our sakes, the national debate on high pharmaceutical prices and affordable health care should include a thorough examination of the costs of excess regulation.