Getting the FDA to retract a decision is like getting the toothpaste back into the tube, once it’s been squeezed out.
Take the current all-star Alzheimer’s drug aducanumab. It’s not a proven but it IS approved. To the hefty price tag of $56,000 a year!
If the drug was prescribed to just one-third of eligible patients, it would cost Medicare $112 billion a year.
But that same society won’t pay for a caregiver who might actually ease the burden on families who have a loved one with Alzheimer’s.
The FDA does not and cannot guarantee that drugs that come to the U.S. market actually help Americans live longer or better lives (beyond what the drugs themselves can achieve).
At the same time, the FDA insists on interfering in the market and sets arbitrary standards for approval.
The combined effect is the worst of all possible worlds: we don’t know if…
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