Thursday, November 08, 2007

The Natrecor Waterboard Tortured Tchotchke

J&J's Scios unit was cited for "inappropriate reminder labeling" by the FDA for distributing a Natrecor heart failure drug computer mouse pad and pen to physicians.

As shown in the mouse pad photo on the left, the image "evokes the concept of a sedentary hospital patient drowning" according to the FDA untitled letter.

NOTE: It's not really a "warning letter" unless it is addressed to the company's CEO. This letter was addressed to Sunita Sethi, Director, Regulatory Affairs at Scios Inc.

According to FDA regulations, reminder labeling is labeling that calls attention to the name of the drug product, but does not include its indication or dosage recommendations or other representations or suggestions relating to the drug product.

"Reminder pieces," says the FDA, "may not include, among other things, representations or suggestions concerning effectiveness or patient population. Because this image makes these implications, the pieces cited above are not considered reminder labeling and appropriate indication and risk information need to be included. However, these pieces fail to include this information."

"Specifically," says the FDA, "the mouse pad and pen present an image of a distressed older male patient in a hospital bed. The patient is submerged up to his shoulders in water ...Simply put, the image evokes the concept of a sedentary hospital patient drowning."

Speaking of "reminders," all this language and imagery reminds me of waterboarding and the recent confirmation hearings for attorney general nominee Michael Mukasey, who has refused to categorically reject the practice as torture.

Imagine, if you will, Sunita Sethi testifying before some FDA panel about whether or not these Natrecor Tchotches were "inappropriate reminder labeling."

Meanwhile, note that the FDA DOES NOT request the removal of all errant tchotchkes from doctors' offices and gives Scios until November 21 to respond to the FDA's request to "cease the dissemination" of the mouse pads and pens. I am sure Scios reps will be working overtime between now and Thanksgiving -- giving away as many of these pads and pens as possible to thankful physicians, saving Scios enough dough to buy all their reps a holiday turkey.

Here's DDMAC's "request":
"DDMAC requests that Scios immediately cease the dissemination of violative promotional materials for Natrecor such as those described above. Please submit a written response to this letter on or before November 21,2007, stating whether you intend to comply with this request, listing all violative promotional materials for Natrecor such as those described above, and explaining your plan for discontinuing use of such materials."
Let's see, Scios has about two weeks to respond with a plan to stop the dissemination, not 2 weeks to actually STOP dissemination. Who knows what timeline the plan would have.

To bad the US FDA is not as powerful as the Chinese FDA (see "What the US FDA Could Learn from China's FDA").

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