FDA fast-track drug review sold to the highest bidder

There are some things you expect to see “sold at auction.”

Foreclosed houses, repossessed cars, artwork…

But fast-track drug reviews?

Yes, that’s right.

An FDA loophole lets companies actually sell fast-track reviews to the highest bidder.

So if you thought the review process was lax before, oh…we are just getting warmed up!

For the low, low price of $67.5 million, drug makers Sanofi and Regeneron purchased an FDA priority review voucher, or PRV, for their dangerous new cholesterol-lowering drug.

A PVR is given to a company by the FDA as a reward for making a drug for a “neglected” tropical disease, or a rare childhood one.

And the original PRV holder, a small drug company in California, was awarded the voucher when it came out with a drug for children who have a little-known condition called Morquio A syndrome.

But nothing in the rule book says they have to keep their prize. If they want, they can sell it to the highest bidder – which in this case turned out to be Sanofi and Regeneron.

Now one company is almost $70 million richer, another is about to be worth billions more, and millions of Americans are about to lose everything in this FDA-version of the shell game.

Source:

“BioMarin sells special FDA voucher for $67.5 million” Stephanie M. Lee, SFGate, blog.sfgate.com