Here are some thoughts related to Johnson & Johnson’s decision to stop selling its power morcellator, long after the FDA approved it to remove fibroid tissue inside a woman’s uterus, because evidence indicated it could spread cancer in women.
We recognize a general tradeoff between innovation and regulation. That is, we are usually willing to slow development of new, potentially beneficial products and techniques in order to protect public safety. This principle of caution applies with special force to medicine: government regulates medical technology, devices, methods, drugs and so on to make sure innovation does not accidentally harm people.
So why do we have one case after another where the FDA fails to perform its mission? Are they careless or negligent? Do they not know how to analyze data or make judgments about risk? Are they in the pockets of the companies they regulate? Do they focus on the wrong things when they undertake their regulatory activities? Are they ignorant?
One possibility escapes public discussion: suppose you can’t regulate innovation in the way the FDA thinks you can regulate it? What if a regulatory agency of this type necessarily experiences an astonishingly high failure rate, where it approves things that turn out to be dangerous, and prohibits things that, in other countries, turn out to be beneficial?
That is what we have found with the FDA. It does not get things right. The extraordinary power it exercises serves no one well.