The Food and Drug Administration, which historically has been quite conservative about approving new medications, has loosened the reins in recent years in response to the demands of patients with debilitating illnesses for quicker access to still experimental drugs.
The results have been controversial, with government and private insurers getting billed for extremely expensive drugs that may not work as touted.
This week, a relatively small drug company in Massachusetts announced it was pulling from the market, less than two years after FDA approval, its drug for treating Lou Gehrig’s disease. That withdrawal comes after a large study showed that the drug — with an annual sticker price of more than $150,000 — doesn’t work on the deadly neurological condition.
Obviously, the approval was premature, as was the FDA’s approval of another controversial drug, Aduhelm, in 2021, even though it had not been proven that it could actually slow the disease, Alzheimer’s, for which it was invented. That approval caused such a stir that Medicare heavily restricted on what patients it would pick up most of the $56,000-per-year tab. Earlier this year, the drugmaker decided to stop manufacturing it.
Drug companies defend the eye-popping costs of new drugs when they are rolled out, saying they have a limited time before the drugs go generic to recoup the $2 billion to $3 billion it costs to research and produce a new drug.
That might be understandable for drugs that work. It isn’t for those that don’t. The FDA, by approving drugs prematurely, is in effect asking the public — through Medicare taxes or private insurance premiums — to partially underwrite the development of unproven medications, some of which never pan out.
It’s fine for the drugmakers to hit a big payoff when they create a drug that slows or reverses a serious illness. That’s how the free market is supposed to incentivize innovation. Drugmakers should not cash in, though, on their failures. If they get the idea that they can make money regardless of the effectiveness of their drugs, that will entice them to be sloppy or misleading in their research.
The FDA is supposed to be the gatekeeper that prevents this. It needs to return to being tougher on approvals.
