FDA Plans Meeting On Med Guides
3 CommentsBy Ed Silverman // March 23rd, 2007 // 2:24 pm
Where have all the Med Guides gone?
That’s what the FDA will try to figure out in a public meeting this spring In a March 20 letter, Steve Mason, acting assistant commish for legislation, wrote NJ Congressman Mike Ferguson that the agency is aware guides aren’t always dispensed with prescriptions. Pharmacies, he acknowledged, aren’t “getting sufficient quantities…with drugs that require these.”
This is a problem, especially since the FDA is requiring more Med Guides all the time. The latest examples: sleeping pills and ADHD meds. Anecdotes have circulated for months, though, that Med Guides sometimes don’t accompany antidepressants. Under pressure from several constituents, Ferguson contacted the FDA, drugmakers and pharmacy groups.
Pharmacy groups say they sometimes have trouble getting the guides from brand-name drugmakers, who insist they follow FDA rules and distribute the guides, according to letters sent Ferguson. Of course, there are also generic makers that must be monitored and it’s not clear about the extent to which these companies comply.
The FDA move is long overdue. The agency was alerted to the problem last summer, but didn’t take action. Last fall, in response to Ferguson, the FDA offered to meet with his constituents, but two of the most vocal NJ citizens tell Pharmalot they were never informed and no meeting took place. In any event, Andy & Co. should sort this one out. Otherwise, all those FDA warnings issued may never reach the intended audience.
This is the FDA letter to Ferguson:
Page 1
Page 2[tags]FDA, Medication Guides, Mike Ferguson[/tags]
Melody
If a recent study showing that 45 million adults in the U.S. cannot read is accurate, then I must ask who will read these Med Guides to illiterate consumers?
Dr. Ann Blake Tracy
Not to worry Melody, for years only the very rich could afford these pricey designer meds anyway. They are well educated. But after you start on the antidepressant it becomes extremely difficult to focus - at least enough to read, much less understand what someone is telling you the med guide says - not sure how to handle that problem. It has only been since the government has really begun to kick in payment for these drugs that the uneducated and illiterate could afford them.
WITHOUT DOUBT it is LONG OVERDUE that this step be taken to insure the FDA warning issued on these deadly drugs get out to the patients who need to be aware of those warnings and accompanying guidelines! What good does a warning do if it is given to no one who needs it?
Thank you Ed for such a great site where such important issues that affect us all are being addressed!! Well done!! If you have not checked out our web site lately you will want to do so. We have posted some very interesting information on Columbine and these medications.
Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
http://www.drugawareness.org
Laurie
[B]“but two of the most vocal NJ citizens tell Pharmalot they were never informed and no meeting took place.”[/B]
:)