Generic Drugs Hit Backlog At FDA

[FlaGranny]

"The FDA's Buehler said the agency gives priority to "first generic" applications, for drugs just losing patent protection, but documents show that the backlog for all generics is double what it was just three years ago.

As the backlog of generic applications has soared, the number of applications for new or reformulated drugs and biologics submitted by brand-name companies has remained consistently smaller than predicted. But while the Office of Generic Drugs had about 200 employees to process almost 800 new applications last year, the offices that review new drugs had more than 2,500 employees for about 150 applications in 2004.

The generics office's budget was about $26 million last year, a fraction of the more than $400 million spent to evaluate and monitor new drugs and biologics, according to FDA documents. In response to questions from Congress, the agency said the generics program would have to make cuts in 2006 to offset pay raises.

"We have a kind of crazy situation now where the FDA's generic reviews -- which are supposed to be quicker because they're less complicated -- on average take longer than the new drug reviews," said Kathleen Jaeger, president of the Generic Pharmaceutical Association. "The flood of applications is coming in generics, but the review resources mostly go to new drugs."

More at:
http://www.washingtonpost.com/wp-dyn/content/article/2006/02/03/AR2006020302598.html

This is shocking - but not really. I don't think the FDA cares whether we can get generic drugs as long as the drug companies are making a nice profit.

P.S. I hope this hasn't been posted before. I couldn't find it.

[liberaltrucker]

1. You're right

FDA doesn't care. The patent ran out on the med I take 5 years ago,
Wyeth has fought attempts for generics. As a result, the drug still
costs $150/month. Fortunately, I have a $100/year deductible and a $25
co-pay.

[Warpy]

2. Generic Prilosec was stalled for three years

while the patent holder fought like crazy to keep generics off the market by questioning everything from the actual formulation to the color of the capsules. When it became clear they'd lost the fight, they quickly trotted out the "me too" Nexium and put Prilosec OTC, thereby shutting down all the generics and costing them a fortune in trying to get the drug out there after the patent had expired.

This is my main example of dirty dealing and stonewalling by Big Pill. It was unconscionable and the fact that they were allowed to get away with it is clear evidence of the massive corruption at the FDA.

My guess is that Big Pill is now doing all it can to repeat this "success story" of keeping a generic off the market and trying to break a company that produces generics.