What FDA Bullies Cost Us
Fewer medical options are the price of bureaucratic "caution."
We're told government protects us, but protectors quickly become bullies. Take the U.S. Food and Drug Administration (FDA). 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.
There are only two ways to do things in life: voluntarily or by force. Government is force. Government bureaucrats, who spend their whole lives pushing the rest of us around, easily become bullies.
We need some government force. The worst places in the world are countries that don't have rule of law. Then people are afraid to build factories because mobs may steal what they make, or a dictator may take the whole factory. No one builds, so everyone stays poor.
It's good America has rule of law. It's good we have a military to defend us from foreign attacks, police that keep the peace, courts that ensure contracts are honored, environmental rules that punish polluters.
But now our government goes way beyond that. It employs 22 million people. Not all have the power to impose force on the rest of us, but millions do. Some use it to bully us in big and petty ways.
Twenty-two million government workers delay the Keystone XL oil pipeline, raid poker games, force us to put ethanol in cars, prohibit drugs and medical devices that might make our lives better, take about half our money, and jail more citizens than even China and Russia do.
Like frightened kids in elementary school, we learn to accept this, to think it's natural. But it's not right that government forbids people in pain to make their own choices about what might help them.
Voluntary is better than force. Free is better than coerced. We're better off when government is small and people are left to do as they please, unbullied.