Wednesday, October 3, 2012

FDA sides with the little guy... for a change

This is copied from Daily Dose with William Campbell Douglass II, M.D.

FDA sides with the little guy... for a change
It's like the school bully complaining that the kids from the chess club are picking on him.

The bully in this case, of course, is a drug company. Specifically KV Pharmaceuticals, and they're griping that a bunch of compounding pharmacists -- sorry guys, but you're the chess club -- have "stolen" the company's drug.

And just like in the cliché Hollywood movies, this bully got his comeuppance -- in court, not on the playground, but the result is the same: The bully is done for.

KV, as you may recall, slapped a patent on an inexpensive hormone treatment given to women at
risk of a preterm birth -- a treatment that compounding pharmacists had been making for years for about $10 a shot.

That adds up to $200 after the 20 treatments needed during a high-risk pregnancy.

KV's version initially cost $1,500 a pop -- or $30,000 per pregnancy -- so you can see why there was a huge outcry when the pricing was announced. The company quickly cut that price in half, but who's going to pay even that much when the chess club is still selling it for $10 a pop?

So KV did what drug companies do best. No, not make a better drug... they sent their lawyers after the pharmacists, issuing everything short of death threats.

Business as usual, so far -- but here's where the story take an unusual turn: The FDA told KV to back the heck off and said it would allow the pharmacists to keep making their cheap version of the drug.

Shocked? Me too. Then, KV took the FDA to court, asking a judge to force the agency to stop the pharmacists.

And now, the judge has spoken -- KV lost, and the company's goose is so cooked that it could go under. They already filed for bankruptcy in August, and winning this lawsuit was pretty much the company's last hope.

Lesson for today: Don't mess with the chess club.

Thursday, July 5, 2012

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