WP: Generic Drugs Hit Backlog At FDA (BushCo not trying to speed it up)

[Pirate Smile]

Generic Drugs Hit Backlog At FDA
No Plans to Expand Review Capabilities

By Marc Kaufman
Washington Post Staff Writer
Saturday, February 4, 2006; Page A01

At a time when low-cost generic drugs are being embraced as among the few ways to slow 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.

"We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog," said Gary Buehler, director of the agency's Office of Generic Drugs.

He said he expects a record number of applications this year -- and an even larger backlog -- because "we don't believe we'll be getting any staff increases in 2006." Buehler said his office received an all-time monthly high of 129 applications in December.

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

BushCo continues to pay back the Drug Co's for their contributions.

Thanks for the checks, we'll make sure the generics come on line slooooowwwwly.

[CAG]

1. Don't the repukes know that generic companies are ALSO private businesses

that need to survive too??

Of course, the generic firms don't have the billions to throw around to all of the repukes reelection campaigns, though, do they?

[Pirate Smile]

2. Here is the standard "say one thing publicly, do another behind the

scenes".

"The Bush administration has strongly advocated generics as a way to hold down health care costs, and the director of the Centers for Medicare and Medicaid Services, Mark B. McClellan, said in an interview this week that an ever-growing number of generics is essential to controlling the cost to the government and seniors of the new Medicare prescription drug program.

In a recent federal report on health care costs, one of the few bright spots was a slowdown in the rate of prescription drug spending that was credited largely to the growing use of generics, which now account for more than half of all prescriptions.

"This huge backlog of generic applications is just unacceptable," said Rep. Henry A. Waxman (D-Calif.), one of the sponsors of the law that made generics more easily available two decades ago. "This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind."

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."

[Cobalt Violet]

3. A repuke will kill 100 people for $1.00 profit.

The most evil people on earth.

[Trillo]

4. Interesting.

Impeach.

[salin]

5. Meanwhile many of the Medicare Plan D plans

that are the least expensive (and thus most affordable *cough* to those with just a little too much income to qualify for assistance) ONLY cover generic drugs.