Ms. Bojsen:
You ask an interesting question about the procedures. While I can't comment on how my clients approach this, I did want to make a couple comments about the legal aspects of FDA regulation of websites as advertising.
First, it is important to keep in mind that FDA does not solely regulate websites as advertising. Indeed, there are certain types of products for which FDA lacks the legal authority to regulate their advertising such as OTC drugs, dietary supplements, and certain medical devices. Rather, the Federal Trade Commission (FTC) exercises control over the advertisement of these products. In those cases, FDA's power "solely" extends to labels and labeling. I say "solely" because FDA still has formidable powers over labels and labeling.
Because of this, FDA does not solely recognize websites as being advertising. Rather, the agency also construes a website to constitute labeling and, thus, can exercise "labeling" jurisdiction over a website for products for which it lacks the power to regulate advertising for that same product. Indeed, in certain circumstances, the cynical among us suspect that FDA, for other products, such as prescription drugs, where the agency does have the power over both advertising and labeling, will choose to regulate a website -- from the perspective of construing it as either advertising or labeling -- depending on which perspective gives the agency the most leverage to exercise its powers relative to whatever concerns the agency has about the website in question.
You are wise to raise the issue of foreign portions of websites. Frequently, companies market products that are subject to different regulatory requirement - including indications and intended uses -- in the United States as opposed to abroad. However, if your website allows an individual to access any part of the website without making absolutely clear whether the webpage that the browser has landed on is for U.S. consumption or foreign review, this can generate significant concerns from FDA if it means the U.S. consumer has access to information relating to uses or warnings that are not allowed in the U.S.
To address this, many companies keep the foreign portions of their sites totally distinct from their U.S. versions and even require that a person entering the foreign portion of the site affirmatively represent that they are not in the United States (and vice versa). Alternatively, the site will ask the browser to affirmatively state that they understand that the part of the website they are accessing relates solely to non-U.S. issues. Also, care must be exercised to ensure that links do not inadvertently go from a U.S. portion of a website to its foreign counterparts.
Given that FDA can exercise either labeling or advertising authority over a website, depending on the factors I alluded to above, while it is fully understandable that you want to implement an efficient change process for processing revisions to your website, this must be approached with care. Indeed, one of the challenges of reviewing a website by printing it out, is that you will lose the "live" aspect of the links that can be accessed from a specific page. For example, it is very important to exercise care with any links that refer to sites outside your website, such as references to public literature or other articles.
Finally, please also keep in mind that FDA will regard any social media page such as a Facebook, Twitter or YouTube account that your firm sponsors as subject to FDA's jurisdiction. From that perspective, anything posted by third parties can represent a testimonial that could cause your products to be misbranded if the testimonial makes a claim that is outside of those that are appropriate for your product.
In April, I gave a presentation on FDA's regulation on social media that you might find of interest on some of the issues I have discussed above. You can access that presentation at the following link:
http://www.fdacounsel.com/files/Swit_--_OCRA_Social_Media_PPT_--_20120417.pdf
I hope this information is helpful to you and wish you the best of luck in your project.
Best regards,
Michael A. Swit
______________________________________________
Michael A. Swit
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit https://twitter.com/FDACounsel -------------------------------------------
Original Message:
Sent: 09-21-2012 10:17
From: Paula Bojsen
Subject: Website change control
Hi all,
FDA regulates websites as they do advertising. I am wondering what everyone is doing regarding how website content is reviewed and approved.
- Do you print out the web pages, give them a document number, and route a change order?
- Do you download the website and review and approve changes that way, documenting the changes in a change order?
- Do you include your foreign websites? I don't believe that these require change control the same way FDA requires, but your input would be valuable.
We are totally redoing our website, and it may come to about 2500 pages, so we need a fast but defendable way of doing review and approval. Any ideas out there?
Thanks,
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Paula Bojsen
Grand Rapids, MI
United States
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