Adverse Event? Call 1-800-What-FDA?
3 CommentsBy Ed Silverman // February 8th, 2007 // 1:33 pm
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. But 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…..
[tags]Bart Stupak, Drug Labeling, FDA, House Energy and Commerce Committee, Mike Leavitt[/tags]
Melody
If it takes this “leader” more than 2 years to create a label with AE phone number, I would suggest that the possibility of even approaching a revision/reform of this convoluted, broken system of reporting adverse events is approaching nil.
You can read about this horribly mismanaged system that makes a mockery in the book “Too Profitable to Cure.” One pertinent statement:
The government has accepted the responsibility for collection, interpretation and action related to prescription and over-the-counter drug incidents: The adverse events reports (AERs) are a compilation of reports submitted by patients, doctors, hospitals and pharmaceutical companies. But, these reports are considered to reflect only 10% of events that actually occur. (An earlier chapter shows that 90 to 99% of adverse events go unreported). Reporting is time-consuming, requiring not only paperwork, but a responsibility for follow-ups. And reporting is voluntary!
Laurie
The Medwatch system is an absolute joke. It took me a while to figure how how to submit a report and I’m a nurse!!! Even more sad is the fact that I never knew it existed prior to my son almost dying. 23 years a nurse and I had NO clue it existed..where does that leave the general public?
Melody
Laurie–
It leaves the public with the erroneous impression that the FDA is looking out for us! That’s a scary thought, isn’t it? Which leads to an even scarier thought. If Big Pharma succeeds through lobbying/legislative efforts to remove their own accountability in marketing dangerous drugs, the patient will have absolutely NO recourse. When “FDA-approved” on the label vanquishes the possibility for legal redress, we (the public) will be nothing more than compliant guinea pigs.