FDA Med Guide Meeting On June 12 & 13
3 CommentsBy Ed Silverman // April 6th, 2007 // 5:06 pm
Where have all the Med Guides gone?
That’s what the FDA will explore in a public meeting. Last month, Steve Mason, acting assistant commish for legislation, wrote NJ Congressman Mike Ferguson that the agency is aware med 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. The problem has irked parents, including several in New Jersey, who pushed Ferguson hard to do something.
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 wants input from consumers, pharmacies, drugmakers and wholesalers in hopes of finding ways to ensure Med Guides are circulated with prescriptions as required. One NJ parent, Lisa Van Syckel, says the move is overdue because the agency was alerted to the problem last summer. “It’s not a case of ‘better late than never.’ ” she says. “Make doctors disribute these guides. It’s the doctor telling someone to take a drug in the first place.”
Here’s the…
FDA notice in the Federal Register about the meeting.
This is the FDA letter to Ferguson:
Page 1
Page 2[tags]Medication Guides[/tags]
Laurie
A drug safety warning that no one see’s is NOT a warning. Pharma and the FDA have been playing hot potato with who is ultimately responsible. Bottom line, if it’s serious enough to warrant a Med Guide, then the doctor should be presenting it AND DISCUSSING it with the patient PRIOR to writing the prescription. Simple case of patients rights.
Lisa Van Syckel
PATIENTS HAVE RGHTS!! WOW! HAS ANYONE INFORMED PHARMA AND FDA.BETTER YET,- WE SHOULD NOTIFY DR’S OF THIS BREAKING NEWS!!!!!!!
Laura Borst
When drugs that are potent enough to require physicians’ prescriptions to be sold, they should be sold with guides about their risks, contraindications, and cautions that patients using them should take. Most prescription drugs are synthetic chemicals and they are often very potent as well. Some of them have extremely dangerous side effects, so patients taking any drugs should be given Medguides or information about any safety hazards associated with such drugs. Many of the SSRIs have been shown by previous FDA hearings and other sources to increase the risks of suicidality in children. Most sleeping pills and drugs utilized to control children labeled with “ADHD” (which are usually amphetamines) are highly addictive. Sedatives can be very dangerous, because they often have disabling side effects, which can increase the risks of accidents in people who take them. Therefore, all known side effects and long-term risks should be provided in medication guides. Pharmacies and drug companies should be required to provide Medguides with all prescription drugs that they sell.