We're told government protects us, but protectors quickly become bullies.
Take the Food and Drug Administration. It seems like the most helpful part of government: It supervises testing to make sure greedy drug companies don't sell us dangerous stuff.
The FDA's first big success was stopping thalidomide, a drug that prevented the nausea of morning sickness. It was approved first in Europe, where some mothers who took it proceeded to give birth to children with no arms and legs.
The FDA didn't discover the problems with thalidomide. It was just slow. The drug application was stuck in the FDA's bureaucracy. But being slow prevented birth defects in America.
It taught politicians and bureaucracy that slower is better.
Then the FDA grew, like a tumor.
Today, it takes up to 15 years to get a new drug approved. Though most devices and drugs never are.
What do Americans lose when regulators say "no"?
Usually, we never find out. We don't know what vaccines or painkillers are never developed because regulation discouraged companies from trying something new.
But here's one example where we do know what we lost:
Uterine prolapse is a common and nasty complication of childbearing. It causes urinary incontinence and terminates most couples' sex lives. Complicated surgery and clumsy devices didn't offer much help until device companies developed implants that often did.
However, since biology is unpredictable, some implants fail. In 2011, the FDA abruptly demanded "more studies."
The bullies' mandate unleashed a hornets' nest of tort lawyers. They advertised, "Did your device fail? Call, and we will get you money!" They soon piled up so many suits that device manufacturers' insurers canceled liability coverage. Device companies then withdrew devices from the market.
So now women suffering from uterine prolapse have fewer options. This is a price of bureaucratic "caution."
Reasonable people can debate whether the FDA assures product efficacy and safety. But the regulatory boot always presses toward delay.
Innovators don't dare make a move without saying, "Regulator, may I please?"
In rare cases, when new devices are approved, there is a new obstacle: complex marketing restrictions. Say something about your product that the government doesn't like, and you may be fined. The Office of the Inspector General and federal and state prosecutors troll for rule violations, then sue and fine.
This harms patients. Most never know they were harmed, because we never know what we might have had.
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