When FDA officials crack down and get tough, try not to laugh

What does the FDA look like when it gets tough and cracks down on a drug company?

Imagine Betty White trying to hit a Major League fastball.

Recently, the agency “cracked down” on Shire Development, a company that makes a drug called ProAmantine–a treatment for low blood pressure.

FDA officials originally gave ProAmantine a fast-track approval because someone at Shire convinced them that the drug had the potential to save lives.

But all accelerated approvals come with the requirement that further clinical trials have to be conducted to show that the product is actually effective.

To date, Shire hasn’t conducted any additional trials. So the FDA is flying into action and cracking down–yeah!–a mere 14 years after the drug was approved.

Uh…what?

That’s a one and a four–14 years!

ProAmantine has been on the market so long it’s gone generic! And all that time, doctors have been prescribing it to thousands of patients, secure in the faith that the FDA wouldn’t approve a drug that wasn’t shown to do what it’s supposed to do.

Oh, FDA…in the global jungle of giant drug companies, you’re such a sweet little kitty.

To Your Good Health,

Jenny Thompson

Source:
“FDA Proposes Withdrawal of Low Blood Pressure Drug” FDA News Release, 8/16/10, fda.gov