Why you should never trust a drug that gets “fast track” FDA approval

I expect most of the general public sees the FDA as an alert guardian at the gate, always diligent to make sure that only effective and safe drugs are approved.

In reality, this guardian is more like Barney Fife.

But even that’s being too generous.

According to a new investigation, the FDA is more like a friendly doorman who’s always happy to throw open the doors for regular customers.

And make no mistake. Drug companies are the FDA’s best customers. They all pay hefty fees for drug approval. And those fees run especially high for accelerated approval, which is more widely known as “fast tracking.”

That’s good business for drug companies (and for the FDA).

For consumers? Not so much.

In a new study, researchers from the U.S. and the London School of Economics (LSE) took a close look at 37 drugs that were fast tracked between 2000 and 2013.

An LSE press release summed up their findings on the accelerated FDA approval system in two words: major flaws.

Which translates to major problems for many patients who find out the hard way that the drug they were given wasn’t approved quickly because it was superior. Rather, it got a quick approval because the drug company convinced the FDA it has the potential to provide benefits.

As the LSE study shows, the key to this system is what the FDA refers to as “surrogate endpoints.”

That just means that instead of basing approval on a series of so-called “gold standard” placebo controlled clinical trials, approval is based instead on lesser measures that, in the FDA’s own words, are “thought to predict clinical benefit.”

Thought to predict? That’s a shockingly flimsy criteria for drugs that people depend on to treat life-threatening diseases.

In another recent review of the fast-track system, the New England Journal of Medicine reports that six out of 15 cancer drugs assessed by researchers were later proved to offer no survival benefits.

Let’s just call a spade a spade here: This “fast-track” system is pure junk!

We now have proof that rushing drugs to market results in many patients getting useless treatments.

As I’ve mentioned before, taking any newly approved drug is risky. Whatever we know about a drug’s benefits or potential harms when it’s new usually changes drastically within three to five years.

And that warning goes double for drugs fresh off the fast track.




Major flaws in US drugs with ‘accelerated’ approval, research suggests

London School of Economics

June 7, 2017


Accelerated Approval Program


Accelerated FDA approval and pricey drugs make a rotten combo, doctors argue

Fierce Pharma

May 25, 2017