How IVD companies can handle FDA regulation when they engage into Social Media?

DISCLOSURE INFORMATION:

My name is Thibault Géoui, I am a product manager at QIAGEN, a biotech company which is selling IVD products, nevertheless, the products that I am covering are not IVD products (R.U.O). This document has been written by me and for my own research, without the oversight of the company, its primary intention is to answer research questions that will be included in an MBA master thesis.

I want to find general answers that will serve the community: not only companies engaged in IVD, but also patients’ communities and physicians. What are the rules for engaging with companies online? What kind of information a company can and cannot provide on Social Media platform (e.g. blogs and forums)? How to deal with miss-leading information or off-label promotion which doesn’t originate for the company? ….

How to deal with Social Media in a regulated industry?

I am not a regulatory person, however I understand that one of the biggest concerns of my colleagues in engaging into Social Media activities, is the apparent the lack of regulatory framework. At the end of 2009, the FDA organized a hearing with companies engaged into Social Media, to work out rules and regulation for the industry, however the guidelines are not yet published, and although they might be soon, I am afraid that the lack of regulatory training of many marketers (and I first) might render those rules difficult to enforce, or limit the Social Media activities of many companies.

I already did quite a lot of research on that, but I have to say that I am a bit overwhelmed, and I don't really know what to do or what to think

First of all, I'm trying to get a big picture of how FDA regulates labeling and advertising in general, and also what is covered by the FDA, and what is covered by other regulatory agencies. On some websites, I read that the FDA covers only labeling (in its broadest sense) and that advertising is covered by the FTC, while on other websites, I read that FDA covers everything.

My latest reading says that according to the FD&C Act, FDA covers labeling and advertising and that the rules to follow are the following:

• Be truthful; that is, not false or misleading in any respect.
• Contain a fair balance of the risks and benefits of the device, with clear context, layout, and format of the information presented.
• Have adequate substantiation, based on well-controlled studies or supporting evidence.

In case of Direct-To-Consumer activities (and I guess that Social Media fall into that?), the rules are the following:

Include a brief statement requirement (section 502(r):

• Discloses the most serious and the most common risks associated with the device in either the audio or audio and visual parts of the presentation
• Makes adequate provision for dissemination (mailing, phone service, accompanying print advertisement, brochures in public places such as pharmacy … ) of the approved or permitted package labeling[1] in connection with the broadcast presentation

Off-label promotion

Not permitted except to medical professional, and not being proactive

Prelaunch promotions

Not possible because the claims are not yet approved by the FDA BUT the status of product development can be communicated with PR, and scientific data can be presented for educational purpose

Pharmacoeconomic claims

Can be done only with certain target groups such as health economics professionals, but not patient or MDs.

Relevant warnings, precautions, side effects, and contraindications (21 U.S.C. 352 (r)(2))

Is this relevant to IVD???

Do I forget something?

I guess that the challenges for Social Media are the following:

No control on the population that listens (except if the websites requires identification and is limited, let's say to healthcare professionals)

• No control on what is being said (except if any message is first moderated ... which doesn't work well for social media)
• No control on how the information is shared (from one network to the other)
• Not possible to continuously monitor activities (.e.g.: when a marketing campaign is finished the monitoring activity will stop, but everything stays on the Web and might be still commented by users)
• Temporality might be an issue, e.g.: Twitter, blogs or forums are instantaneous, while standard marketing communication is always controlled by the regulatory affairs department, therefore a specific training might be required for marketing professionals who will engage into conversation on such platform
• ...

I guess that there are other limitations, which make Social Media a challenge to use, on the flip side, there are also benefits for the patients and health care professional if a company starts to use Social Media:

• First hand information on what the product does and doesn't do
• Reference to the right information (it is possible to point people to white paper, scientific publication or company website where they will find the right information)
• Helping not only patients but also communities of patients by providing guidance in term of the above mentioned information
• Chance to correct some of the miss-leading claims that are done by other patients or support groups on blogs and forums
• Support in pointing out to an adequate solution for a patient seeking information (but here again there is thin line between advertising and giving advice ... how to deal with that?)

Ultimately, should the Social Media activities been done by a marketing professional with a regulatory training or should we sponsor physicians or patients with a specific training to do it on our behalf (with the appropriate disclosure of relationship with a company, e.g.: financial ...)?

Any comments or correction are more than welcomed.

Feel free to contact me at the following address : thibaultgeoui@gmail.com

Dr. Thibault Géoui

[1] Labeling might be too technical for most patient, therefore it is suggested that a abbreviated version of the labeling be produced with the following information: “indications, contraindications, warnings, precautions, and adverse effects” , nevertheless patient need to be informed that this is an abbreviated version of the label

References used in this document come from:

• Daniel Schultz, FDA Oversight of Direct-to-Consumer Advertising of Medical Devices, FDA, online publication: http://www.fda.gov/NewsEvents/Testimony/ucm096272.htm
• Philipp Novales-Li, Policies guiding the advertising and promotion of IVD products, IVD Technology, April 2009, online publication: http://www.ivdtechnology.com/article/policies-guiding-advertising-and-promotion-ivd-products
• Diagnostic Kits/USA Regulation Review, online publication: http://cyber.law.harvard.edu/commonsbasedresearch/Diagnostic_Kits/USA_Regulation_Review
• Draft Guidance for Industry and FDA, Consumer-Directed Broadcast, Advertising of Restricted Devices, FDA
• Guidance for industry, “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms, FDA, online publication: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070068.pdf