(IOM) Panel: FDA Needs Drug-Safety Reforms

[Guest guest]

Institute of Medicine Report Wants Congress to Give Agency New

Safety Enforcement Powers

By Todd Zwillich

WebMD Medical News

September 22, 2006

http://www.webmd.com/content/Article/127/116809.htm?pagenumber=2

----

From ABC News -

http://abcnews.go.com/Health/story?id=2480433 & page=2

[excerpt]

The pharmaceutical industry questioned some of the conclusions of

the report.

" It would be a mistake to accept the notion that the FDA drug safety

system is seriously flawed, " said Caroline Loew, senior vice

president of the Pharmaceutical Research and Manufacturers of

America.

" After all, fewer than 3 percent of approved prescription drugs have

been withdrawn from the American market for safety reasons over the

last 20 years, " Loew said.

-----

It's interesting to see how ABC presented this story -- giving the

pharmaceutical representative the final comment.

[Guest guest]

" HASN'T been done " DOES NOT equal " NO NEED to be done " !!

I'm guessing there are plenty of " FDA Citizen's Petitions " (on a

whole range of topics) questioning " safety issues " that languish in

the deep recesses of the FDA....and if these " petitions " were

SERIOUSLY addressed, Ms. Loew's " pretty number picture " would

quickly turn into a nightmare for the FDA....

The CoMeD " Citizen's Petition " (which we filed in August of 2004)

continues to sit in " limbo land " ....

Kelli

Institute of Medicine Report Wants Congress to Give Agency New

Safety Enforcement Powers

" After all, fewer than 3 percent of approved prescription drugs have

been withdrawn from the American market for safety reasons over the

last 20 years, " Loew said.

[Guest guest]

The IOM might have made a good critique of the failings of the FDA,

but they are 180 degrees off base with their recommendations. The

problems are political and have infected the reasonings of the IOM

themselves as well as corrupting the FDA. The solution is not to

bloat the FDA to become bigger -- just the opposite! The FDA needs to

be privatized and taken out of the sleazy hands of politicians and

pharma interests.

There is already a great model for the private of testing of comsumer

products, its Underwriters Laboratories, Inc. Check it out:

http://www.ul.com/

The IOM has little credibility with me, considering their whitewash of

the dirty vaccine controversy. They are the last ones to trust for

political reform. Did the FDA fund the IOM study, anybody know, like

the CDC funded their IOM whitewash?

Lenny

>

> Institute of Medicine Report Wants Congress to Give Agency New

> Safety Enforcement Powers

>

> By Todd Zwillich

> WebMD Medical News

> September 22, 2006

>

> http://www.webmd.com/content/Article/127/116809.htm?pagenumber=2

>

> ----

>

> From ABC News -

>

> http://abcnews.go.com/Health/story?id=2480433 & page=2

>

> [excerpt]

>

> The pharmaceutical industry questioned some of the conclusions of

> the report.

>

> " It would be a mistake to accept the notion that the FDA drug safety

> system is seriously flawed, " said Caroline Loew, senior vice

> president of the Pharmaceutical Research and Manufacturers of

> America.

>

> " After all, fewer than 3 percent of approved prescription drugs have

> been withdrawn from the American market for safety reasons over the

> last 20 years, " Loew said.

>

> -----

>

> It's interesting to see how ABC presented this story -- giving the

> pharmaceutical representative the final comment.

>

>

>