Drug Maker Advertising and Social Media

On November 12-13, 2009, the Federal Food and Drug Administration (FDA) held a series of hearings to gather opinions regarding how drug makers should be held accountable for advertising on social media sites (Draft Guidance for Industry on Fulfilling Regulatory Requirements for Post marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability, 2014). The result of those comments in 2009 was a document published on January 13, 2014, in draft format. The issue is very important for all types of business and social media concerns, including TUDiabetes. This is a bit of an overview. To read the entire publication published on January 13, 2014, go to this web site:

 

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInfo...

 

 

Why is this so important?

One has only turn on TV to the see how prevalent drug company advertising is today. It is important to also understand covered companies traditionally wait for FDA guidance before they begin advertising of any kind. That makes sense since regulated drug companies are required to submit “all promotional labeling and advertising pieces at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a drug” (Guidance for Industry Fulfilling Regulatory Requirements for Post marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, DRAFT GUIDANCE, 2014, p. 2). Since social media is dynamic the FDA is generally proposing to allow drug companies to advertise or post items first, without prior approval, then seek post publication approval of the material placed on social media sites.

Have you ever wondered why when you go on Facebook or sign into TUD you are not besieged with advertisements? Actually I did and so I looked it up a few months ago. The 2009 meeting was a veritable zoo. The committee had 50 presentations mostly about the use and identification of properly placed blogs (Young, 2009). One complaint was about how drug companies could be responsible for unauthorized bloggers who might contribute content to a company sponsored web site, thus giving the appearance that the company approved the content when in fact the claims being made were those of nonscientific, uninformed people. In essence companies wished to exclude themselves from such liability from all public blogging claims(Young, 2009). In these draft regulations companies are not given full immunity from such affairs. The draft regulations set out three types of situations and they explain how the FDA will regulate the content as an advertisement.

 

Situation 1, A web site that is owned, controlled, influenced or operated by a covered company:

This may also include microblogs. These are blogs or subsets of larger social media sites including Facebook. In cases such as this the company must submit the web site and its contents monthly for FDA marketing approval (Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, DRAFT GUIDANCE, 2014). This is like a tax on the company for using a company owned web sites. Since the web site and all the material has to be submitted each month, it is unlikely that companies will offer fully owned web sites that are interesting for consumers. Think of a social media site where participants cannot post because the company cannot control the nature of the material on the site.

Situation 2, A company is responsible for promotion on third party sites that they influence:

In this case the company does not own the web site but has substantial influence over the content on the site. A case in point might be a situation where a web site is owned by a third party, but a drug company is on the board of directors of the organization operating the site. Yes they are not the owner, but it is generally understood that some content is not posted or removed in order to maintain the image of a drug or product being promoted. All material on the web site plus site editorial guidelines will be subject to review by the FDA monthly.

Obviously this is designed to discourage companies from operating second sites and posing them as independent. Such front operations may give the consumer the illusion of independence while such a largely controlled by the drug company. In these cases the FDA holding the company to the same advertises restrictions, just as if the company owns and operates the site as an in house venture.

Situation 3, A true third party site:

This is one of the main reasons for the regulations. Likely the FDA had enough regulation in place to force compliance with the FDA advertising in the other two scenarios. If not they could have released some amendments to the standard advertising regulation package to cover the other two situations. (my opinion). However in the case the FDA wanted to state empathically that company actions to advertise or dispense information without supervision would not be tolerated.

So in this scenario an individual paid by a drug company may post information on a social media site not controlled by the company (Facebook, TUD etc.) but those posts must comply with the FDA guidelines for advertising. This will include post submission of items to the FDA to check for compliance with the food and drug act. One part of these regulations require that when a drug company employee makes such posts than they must identify themselves as paid representatives.

Consider if you will the issue of “David Manning” a fictitious movie reviewer used by Sony pictures in advertising around 2000. In the case of “Manning” made up review quotes were attributed to the small Connecticut newspaper the ‘Ridgefield Press’ in order to increase tickets sales of low performing or badly rated movies. The FDA specifically wants to avoid a repeat of this issue in the field of drug sales. Under these regulations doing this would be a federal crime.

The second, and for TUD and similar sites, far more interesting part of this scenario is what happens when a company advertises on the site. In the instance where a drug company merely advertises but does not influence editorial content of a site, then those advertisements alone will need to be submitted to the FDA. Further the company will not be responsible for comments or claims made on the site by others.

So an example, if a company advertises on TUD and I make false or misleading claims about the drug being advertised. The drug company will not be responsible for those comments, provided the company exercises no editorial control on the site. Of course the drug company could pay someone to refute those claims then the follow up post would be subject to FDA oversight.

 

This scenario includes comments made on twitter by company officials.  Those advertising statements would also be subject to  post publication review.

 

Conclusion:

It is difficult to place in this space, the nuances of the proposed regulations. Consider this an overview at best. These regulations will in all probability not be made into law exactly as they are proposed. They regulations do however provide the most current thinking by the FDA on the use of Social media for drug advertisements. In the coming months stand back the flood gates are about to be opened, for better or worse.


References

 

Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability. (2014). Washington DC: Regulations.gov Retrieved from http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1430-0001.

Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, DRAFT GUIDANCE. (2014). Washington DC: Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInfo....

Young, Donna. (2009, November 13, 2009). FDA Hearing Is all ‘aTwitter’ Over Internet Advertising Rules, Bioworld Today.

Special thanks for the blog idea and information goes to:

Kim/Diabetes ‏@txtngmypancreas

-30-

 

Rick

Views: 102

Tags: FDA, Media, Social, blog, diabetic, drug, makerts

Comment by Manny Hernandez on January 18, 2014 at 11:04am

Thanks for posting about this in here, Rick.

I posted the following comment on the docket:

"I want to thank FDA for providing guidance on this front, as it has been a frequent topic of discussion in health social media circles for many years.

As a patient advocate, I feel the guidance goes in the right direction, defining clearly the responsibilities that pharma/device companies have to the agency in connection with online communications. In particular, it's satisfactory to me to see that real-time communications are given such an important level of attention in the guidance, since they are a valuable and growing mechanism through which patients can benefit from interacting with firms.

Social media provides firms the ability to have a conversation with the patients that use their products, not only with promotional purposes but to offer contextual educational information. However, since there hasn't been a proposed guideline until now, a large number of firms have chosen to not engage or engage in a way that has been devoid of the qualities of a natural conversation.

It is my hope that once this guidance becomes official beyond this comment stage, firms that remained unengaged with patients in social media find the necessary reassurance that they were waiting on."

I encourage you to share your thoughts with FDA about this guidance. You will need to do so here.

Comment by Emily Coles on January 22, 2014 at 12:52pm

Rick, awesome job distilling a really complicated (and potentially dry) topic into something digestible!  Thank you so much.

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