Adverse Event? Call 1-800-What-FDA?

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http://pharmalot.com/2007/02/adverse_event_call_1800whatfda.php

February 8, 2007

Adverse Event? Call 1-800-What-FDA?

There was a pretty amusing exchange the other day in Washington

between U.S. Rep. Bart Stupak, a Michigan Democrat who chairs the

House Energy and Commerce Committee's oversight commitee, and Health

and Human Services secretary Mike Leavitt.

During a full committee hearing, Stupak fumed the FDA was five years

late in failing to place a toll free number on drug labeling to make

it possible to report adverse events. The agency was supposed to do so

according to a provision in the Best Pharmaceuticals for Children Act

of 2002, which is due to be reauthorized this year. As

InsideHealthPolicy noted, the FDA was required to issue a formal rule

within one year of the bill's enactment.

" It took FDA more than two years after the bill's enactment to have a

proposal [on a label] despite language in the bill that gives a year

response deadline, " Stupak scolded Leavitt before threatening him with

another hearing over the safety issue. " For more than five years, FDA

has failed to issue a rule. Can we be assured FDA will issue a rule in

the next few months? "

Apparently not. " I share your concerns of drug safety, " Leavitt

responded, and suggested a better method would be an electronic

system. He then added he would respond to Stupak in a letter.

A letter? He could phone in a better response. The man must absolutely

hate telephones.

Maybe he has a cell phone, though. Can someone can share Mike's number

with us?

Hello, Mike? About that adverse event we had the other night.....You

know, the one that caused our heart to stop.....

Posted by Ed Silverman