What happens when you mix over-regulation with messy tort law? Fewer options for women’s reproductive health, according to John Stossel. The media personality recently published a commentary at Reason.com lambasting the FDA for its excessive, and oftentimes arbitrary, regulations that keep crucial treatments from reaching in patients. His chief example was a surgical implant designed to treat uterine prolapse, a common complication of pregnancy.
With all the controversy surrounding women’s health, Stossel reminds us that the biggest hurdles to access lay in the maze of government directives that keep medical drugs and devices from ever finding female consumers:
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?”
….This harms patients. Most never know they were harmed, because we never know what we might have had.