A couple of years ago, James Joyner, a professor at the Marine Corps Command and Staff College, shared a story about how his doctor advised him to treat a cataract. “My surgeon suggested that, if I were willing to wait a couple of months and were willing to pay a couple thousand dollars out of pocket, a revolutionary new lens that had been in use in Europe for years would be approved by the FDA,” he wrote. “The expected approval didn’t come but we agreed to wait another six months. Still, no approval. Meanwhile, the cataract has gotten considerably more advanced and we’re in agreement that waiting around for the FDA no longer makes sense.”
He got the inferior lens, but he wasn’t happy about it. “The absurdity of a lens that’s in widespread use in Sweden and Germany not being available because the FDA hasn’t gotten around to it is mind-boggling,” he complained. “We’re not talking about a back alley in Tijuana or Marrakesh; these are at least comparably advanced countries.” Musing that it could have as easily been a better heart valve or cancer drug, he reasoned, “Surely, pooling our combined knowledge is mutually beneficial.”
That is a major premise behind a bill to overhaul the FDA approval process that Sens. Ted Cruz and Mike Lee have introduced. Approval in a “trusted country” would give doctors and patients here the ability to use a drug or medical device.
Libertarians have long theorized that pernicious incentives would cause bureaucrats to be too cautious in approving new drugs and treatments—approving a dangerous drug would cost them their career, whereas withholding a good or even lifesaving drug from the public would have no cost at all. The lost lives would be invisible.