Rigging the Scale

Washington Post article on backlog of applications to approve generic equivalents of high cost brand name drugs:

“...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.’ [snip]

‘The branded industry has to be delighted by this backlog,’ said Jake Hansen, vice president for government affairs for Barr Laboratories Inc., a maker of generic drugs. ‘If they can't stop competition in the courts, stopping it as applications go through the regulatory process is just as effective. For consumers, to flatline or cut funding makes absolutely no sense.’..."

Corporate welfare at its subtle best.