Like me, you probably have been seeing more ads on TV for medical devices like pacemakers and knee replacements. One ad from Stryker for a knee replacement caught my attention Sunday.
In the ad, a 62 year-old woman with a Stryker knee replacement -- who I learn from the company's Internet site is a real person named Barbara Cotoia, "an active grandmother of six" -- starts walking from NYC, across Amish country, over hill and dale, prairie and Monument Park,up Aztec steps somewhere, and finally descends the mountains in California for a fantastic view of the Golden Gate bridge. Then, just like Forest Gump, she turns around and starts back!
At the beginning of this fantastic trek, the voice over suggests "You'll be surprised how far [Stryker knee replacement] can take you." Pretty damn far indeed!
Clearly, if this were a drug ad, the FDA would be over it like white on rice.
Remember the old Vioxx ads (or was it Celebrex) that showed someone with arthritis knee pain skateboarding after taking Vioxx? The FDA had a problem with that --- it just went to far on the benefit side and the ad was changed to show the guy hobbling along on one good knee, not two!
Imagine the new Celebrex ads showing someone walking across the US! That would surely warrant an FDA letter.
So, what's the FDA position of Medical Device ads? Will anyone there have something to say about this Stryker ad?
In light of FDA's being asleep at the wheel, you shouldn't be surprised how far these device DTC ads will go to push the envelope.
Zimmer has had Gender Knee going for 5 months. I would rather the govt. worry about supplements before squashing the rights of hardworking medical device companies. With no FDA oversight of DTC for Med Device its left to the states and FTC.
ReplyDeleteDTC is gaining momemtum, Device start ups are using DTC for clinical trial recruitment and to marketing of medical devices after recieving marketing approval. Medtronic displays its ad in major newpapers and even on TV. As a regulatroy and clinical affairs expert, I feel that medical device companies can be aggressive with their marketing activities, nothing wrong with that, but also have to be more cautious with thier claims made on TV commercials and advertisments. I feel the FDA (agency) monitors marketing activities very carefully and I know companies have recieved citations and warning letters for mis branding medical products. Readers should keep in mind that FDA is there for helping medical device companies to make sure their product is safe and effective to use in patients with clinical need.
ReplyDeleteIn the above case Stryker's intention was to demonstrate functional improvement after a knee replacement surgery. There has to be a balance between the clinical outcomes, clinical claims, branding, labelling and advertising.
Raj Nihalani, MD, RAC(US)
www.trialmed.com