FDA's enforcement over Website Claims (Medical Device Misbranding)

Ronen E

Problem Solver
Staff member
Moderator
#1
The following FDA warning letters may use as an illustration to the fact that the FDA monitors website contents and holds owners/operators accountable. Specifically, direct claims and indirect representations (e.g. video footage) seem to be monitored against submitted intended purposes (e.g. in a 510k submission) and acted upon.

http // www .fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm306771.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http ://www. fda. gov/ICECI/EnforcementActions/WarningLetters/2012/ucm307258.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
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Elsmar Forum Sponsor
#2
Thanks Ronen. Interesting.

In that second letter they mention that the un-authorised use was featured on the TV show "Greys Anatomy". So do FDA now regard that as "labeling"? I would have thought that it cannot be labeling but then the FDA letter mentions that a company spokesman participated in the making of the TV show, which perhaps puts it into the same category as advertising.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Thanks Ronen. Interesting.

In that second letter they mention that the un-authorised use was featured on the TV show "Greys Anatomy". So do FDA now regard that as "labeling"? I would have thought that it cannot be labeling but then the FDA letter mentions that a company spokesman participated in the making of the TV show, which perhaps puts it into the same category as advertising.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm :

Section 201(m) [of The Federal Food, Drug and Cosmetic Act] defines 'labeling' as:

'all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
Advertising
According to an appellate court decision: "Most, if not all advertising, is labeling. The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising."
Indeed the reference is to "printed or graphic matter", but I am assuming that a case study by a legal practitioner would show that video content may fall inside (if it hasn't already). Anyway, I wouldn't volunteer to test the FDA in court on that...:D
 
L

lfrost

#4
Thanks Ronen. Interesting.

In that second letter they mention that the un-authorised use was featured on the TV show "Greys Anatomy". So do FDA now regard that as "labeling"? I would have thought that it cannot be labeling but then the FDA letter mentions that a company spokesman participated in the making of the TV show, which perhaps puts it into the same category as advertising.
Pads38,

The letter you mention states that the website mentions, and refers to the Grey's Anatmony TV Show. Because it is mentioned on the website, it becomes labeling because it is advertising.
 

Wes Bucey

Quite Involved in Discussions
#5
Pads38,

The letter you mention states that the website mentions, and refers to the Grey's Anatmony TV Show. Because it is mentioned on the website, it becomes labeling because it is advertising.
There is a whole segment of advertising which sprung up in the radio era, expanded greatly with television, and now even appears prominently in theatrical movies: "product placement." The product is featured, mentioned by brand name, and often includes a little dialog mentioning its "good features."

Watch almost any TV show from House (the TV doctor) to Hawaii 50 and you will see products mentioned by brand name and some [or many] good features mentioned. The generic drug, hydrocodone, is a staple of House, but called only by one of the big brands, Vicodin, and it shows that "only over-use results in impaired judgment, but when used as directed, relieves pain without mental impairment" [House's genius for diagnosis is not impaired!] The big brand names for hydrocodone and acetaminophen combinations are Vicodin, Norco, Lortab, Vicodin ES

In Hawaii 50, the dialog between actors gushing over the lead character's Chevy is so over long and effusive, it becomes intrusive on the flow of the drama.

Those manufacturers pay money to the show producers to have their product [versus a competitor's] used and more money to have dialog featuring the brand name.

Given the pervasiveness of product placement, it is about time BOTH FDA and FCC took closer notice of how a brand is featured and discussed on TV or radio.
 

Marcelo

Inactive Registered Visitor
#6
Pads38,

The letter you mention states that the website mentions, and refers to the Grey's Anatmony TV Show. Because it is mentioned on the website, it becomes labeling because it is advertising.
I think "graphic matter" may be an open enough definition so as to include video :)
 
#7
I suppose a device appearing on a TV show without any involvement of the manufacturer is, in effect, "off label use".

But, as Wes points out, any product placement or other manufacturer involvement (programme advisor?) would make it advertising so would be considered labelling.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Here's yet another example of FDA's enforcement over website contents (this time it's adulteration):

http: / /www .fda .gov /ICECI/EnforcementActions/WarningLetters/2012/ucm310790.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

...And two more from July:

http: //www fda. gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312587.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http ://www .fda .gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312585.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Two more from July, recently posted on the FDA website:

http :// www .fda .gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313847.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
http :// www. fda. gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313929.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
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