During the 1950s, drug approval in the United States was a relatively quick and simple process. Then came thalidomide. European regulators had approved this tranquilizer without realizing that it could affect a fetus, and several hundred birth defects resulted worldwide. Capitalizing on the tragedy, liberals in Congress expanded the Food and Drug Administration’s powers and altered its priorities.
After amendments in 1962, a peculiar system of drug approval emerged. With each passing year, that system grew more dilatory, more unbalanced and more costly to patients.
FDA’s top priority became--and remains--prevention of new thalidomides.
Much of our gross national product is spent on prevention: national defense, vaccination, policing, flood control, sanitation, auto safety, cholesterol tests, anti-terrorist measures and burglar alarms.
Our prevention needs are boundless, but resources are limited and must be allocated wisely. Too much allocated to a minor prevention need will leave major needs neglected. Ideally, the greatest good for the greatest number should determine priorities. In reality, narrow self-interest often prevails. Thus, defense contractors build new weapons the country doesn’t need. Farmers get subsidies to grow surplus crops. And FDA churns out burdensome regulations that delay drug approval and actually harm patients.
To better understand FDA’s narrow priority, we need to see it in light of the kinds problems that beset drug regulators. The least common problems are the thalidomides, drugs approved before their safety hazards are known. Even with the pre-1962 FDA, this kind of problem never was a threat comparable to food poisoning or plane crashes. But since Congress blamed FDA for mistaken approvals, the agency made preventing new thalidomides its top priority. Through scare tactics and deception, FDA sold the public on this priority.
Congress and the public are beginning to realize that they have been unwitting parties to a deal made in hell. To prevent a minor threat to public health, FDA created a major health tragedy: needless deaths and suffering caused by delaying useful medicines.
Rational priorities would seek a balance that minimizes the total deaths caused by both mistaken approvals and delays. Rationality and balance are hard. Delay is easy and deals made in hell are tempting.
A recent FDA delay resulted in 3,500 deaths--those kidney cancer patients who, by the FDA’s own figures, would have been saved if the drug Interleukin 2 had been approved here as quickly as it was in Europe. These kidney cancer deaths exceed the number of babies deformed by thalidomide. And Interleukin 2 is only the tip of the iceberg. Delays in approving heart drugs, cancer drugs, AIDS drugs and life-saving devices have contributed to tens of thousands of deaths.
Congress has tolerated FDA delay because its dangers are difficult to prove. Individual patients usually don’t know about the unapproved drug or device that could save their lives. Patients who suffer the worst loss from FDA delay cannot protest from their graves. Fearing retaliation, drug companies avoid blaming FDA for delays.
Few people grasp the complexities of drug development. Few politicians bother to evaluate carefully either FDA’s priorities or the human cost of regulatory delays. Consequently, we’ve lacked effective congressional oversight on FDA. Without oversight, rational policy perishes, deceit flourishes and demagoguery can triumph.
Enter David A. Kessler, FDA’s answer to J. Edgar Hoover. Kessler’s FDA boldly sets its own priorities. It does not shrink from half-truths or scare tactics. It pursues retaliation and selective enforcement without remorse. It has made drug safety and efficacy testing a worse bargain than the Pentagon’s $600 toilet seats. Fortunately, recent House and Senate hearings indicate that FDA abuses are finally arousing congressional watchdogs.
Congress should no longer tolerate the FDA’s perversion of its mission. To prevent a few mistaken approvals, FDA sacrifices countless patients to approval delay, slows the pace of medical progress and drives health-care costs through the roof and jobs out of the country. It’s time for Congress to put patients above bureaucrats and hold the FDA strictly accountable for the human cost of regulatory delays.