Kind of surprising this WaPo
story hasn't gotten any notice. Then again, it's just a drop in the bucket in BushCo's tsunami of lies.
At a time when the use of low-cost generic drugs is being embraced as one of the few ways to rein in skyrocketing health care costs, the Food and Drug Administration has a backlog of more than 800 applications to bring new generic products to the market -- an all-time high.
As a result, experts say, fewer generic drugs will be available to consumers in the years ahead than the industry is ready and able to provide. The FDA, however, has told Congress that the office that reviews new generics needs no additional money, and the agency has no plans to hire more reviewers.
The Bush administration has been pretending for years that it's committed to speedier approvals of low-cost generics. "Bush to Back Measures on Generic Drugs" was the headline of a June 2003 NYT
story.
[Bush] will also announce measures that will increase the number of generic drug reviewers and encourage communication between the F.D.A. and makers of generic drugs. The F.D.A. hopes these measures will reduce the time needed to approve generic drug applications to an average of 17 months from the current 20 months.
Opps. Didn't quite work out that way. From today's WaPo:
Last year, the generics office approved more than 450 applications, 23 fewer than the year before. The office took an average of 20.5 months to review each application, compared with 19.9 months in 1999, although by statute the agency is obliged to do the job within six months.
[...]
As the backlog of generic applications has soared [double what it was three years ago], 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 Medicare drug-benefit boondoggle passed in 2003 is the gift that keeps on giving to the big drug-makers. They successfully blocked efforts to allow Medicare to negotiate bulk discounts for brand-name drugs. Now their bought-and-paid-for administration protects them from competition from low-cost generics