What $125 million buys at the FDA ‘store’

If you think that “tip” Big Pharma gives the FDA — the one called the Prescription Drug User Fee Act (PDUFA) — sounds fishy, there’s another one that takes the fishing tournament prize!

The PDUFA is the fee drug makers “slip” the FDA to get a new drug application in the door. And it’s not cheap. For each new drug that required clinical data last year, Big Pharma forked over $2 million to the FDA.

For that “little” extra, the agency promises to make a decision on your application within 10 months. And everyone there is under big pressure to meet that deadline, and approve those drugs.

But what if 10 months just isn’t fast enough for you?

Well, if you’ve got the money, you can buy a six-month okay from the FDA!

It almost sounds like a board game that you play with the kids or grandkids. An “advance to GO card” from Monopoly!

And here are the “rules” of the game.

When a drug company makes a med to treat what’s called “neglected tropical diseases,” it gets a prize called a priority review voucher, or PRV from the FDA.

So when a Canadian drug maker, Knight Therapeutics, developed a new drug to treat a tropical disease caused by the bite of the sand fly, it was rewarded with one of those PRVs.

But here’s the kicker. They don’t have to keep that prize if they don’t want to. They can sell it to the highest bidder!

And Knight did.

For a whopping $125 million that PRV was won at auction.

And the winner was…Gilead Sciences. That’s the company that makes a drug for hepatitis C that sells for over $1,000 a pill! So we know they’ve got the cash to play this game.

And Gilead can use that PRV for any drug they want. It’ doesn’t have to be a “neglected” disease or even a drug that might save lives.

But with the way Big Pharma’s been playing the drug game this past year, it looks like what they really need is to “Go to jail, go directly to jail, do not pass “Go!”