The Senate is about to vote on a Modernization and Accountability Act, designed to make the FDA's approval process more efficient (for example, by reducing the number of scientific studies required and by placing certain products on a fast-track). The bill, says its sponsor, Senator Jim Jeffords, provides access sooner to newer, safer, and more effective therapeutic products.

By its very nature, the FDA is the primary obstacle to the creation of safe and effective products.

The FDA exists to keep products off the market. Its purpose is not to evaluate new drugs; private manufacturers already do that -- as do private scientists, doctors and pharmacists -- far more rationally than does the FDA. But such entities cannot force you to accept their judgments. The FDA, however, can. The agency's function is to prohibit the individual from judging which sources of information and recommendation to rely on -- to prohibit you from weighing your risks and benefits -- to prohibit products you deem valuable to your life.

As FDA controls expand, new medicines are suppressed. Since 1990, drugs have taken an average of 15 years to go from laboratory to pharmacy shelf (most of which was the time required just to obtain FDA approval). This is almost double the time span of the 1960s.

FDA horror stories abound. Untold thousands suffered and died, for instance, while interleukin-2, which treats metastatic kidney cancer, and TPA, which dissolves blood clots, were kept off the U.S. market -- even though they were widely available in other countries. The FDA's refusal to approve beta-blockers -- used in cardiovascular therapy -- has, according to the noted clinical pharmacologist Dr. William Wardell, set back cardiovascular therapy in this country by years.

Robert Goldberg of Brandeis University's Gordon Public Policy Center concluded that FDA delays in allowing U.S. marketing of drugs used safely and effectively elsewhere around the world have cost the lives of at least 200,000 Americans over the past 30 years.

As long as an FDA is permitted to exist -- regardless of how modern and accountable it is -- such deadly consequences cannot be avoided.

FDA defenders claim that the selfishness of a free market would result in a flood of noxious drugs and defective medical devices, and that only selfless FDA bureaucrats care about how the public is affected. But if so, why don't we trust the non-commercial, disinterested Postal Service more than we do the greedy money-makers at Federal Express?

A private manufacturer has every incentive -- every selfish incentive -- to create products that work. Furthermore, its most valuable asset is its reputation, particularly when it needs to induce physicians and patients to use life-or-death products like drugs. A company's desire for profit provides the strongest motivation to be scrupulously conscientious in protecting a reputation for quality. What, by contrast, motivates a government bureaucrat -- other than a lust for power and a fear of being blamed if something goes wrong?

It is the pharmaceutical industry, not the FDA, that produces safe and effective drugs. If you doubt this, try the following five-year experiment. Ship all the FDA officials to Bangladesh, and leave all the private scientists, inventors and company executives in America. Then see whether Bangladesh produces even one bottle of aspirin, let alone antibiotics, CAT scans and organ transplants.

The FDA operates on the dictatorial premise of preventive law. The agency assumes that pharmaceutical companies are guilty of poisoning the public until their innocence can be proved. Objective law, a cornerstone of the Bill of Rights, rests on the individual's right to be free of government coercion unless there is evidence that he has committed a crime; preventive law cavalierly violates that right by subjecting people to government force without any such evidence.

If one may borrow the immortal words of Thomas Jefferson, the FDA has erected a multitude of New Offices, and sent hither swarms of Officers to harass our people. But Jefferson realized that the solution to oppression was not to modernize the British monarchy, but to abolish it -- and to replace it with a system in which the individual is free of the tyrannical state.

It is a course of action worth emulating.