Congress points fingers, they are to blame!

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Every time a drug company gets rich while consumers die by the thousands

(Vioxx, Avandia, etc.), Congress realizes it's time to kick it into high gear

and convene an investigation.

 

Hello! Earth to Congress! The trail of evidence leads right back to your

house. (At least partially.)

 

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), which

established this directive for the FDA: When drug companies submit a drug for

approval, the agency must complete its analysis and render a decision within

12 months. If 90 percent of all drugs up for approval are not approved or

rejected within 12 months, funding for the agency will be reduced.

 

Wait--it gets better.

 

In 1997, Congress changed the deadline to 10 months. And the 10- month

deadline was renewed in 2002 and again in 2007.

 

So when Harvard professor Daniel Carpenter examined data on drug approvals

going back to 1950, he found that since 1992 a disproportionate number of

approvals have been granted right before the deadline.

 

And when he compared the long-range outcome for those drugs approved at the

last minute to the outcome for drugs that were given a longer approval

process (sure, you can see it coming a mile away), drugs that squeaked under

the deadline were much more likely to require FDA safety intervention after

the drugs were on the market.

 

In other words, meeting the deadline was more important than ensuring safety.

 

 

Congress, you really do know how to invent a Catch-22. Maybe it's time to

change that PDUFA thing into something that cares more about human lives than

drug company marketing plans.

 

To Your Good Health,

 

Jenny Thompson

 

 

 

 

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