The long awaited?FDA draft guidance on social media?is probably not what many in the industry wanted. It does not make doing social media easier or provide more options to creatively use new media. It essentially is a guide to what content a drug company is responsible for and when it is not responsible. It is not surprising in how it defines company versus third party content.
?No lessening of traditional standards.? - Bob Ehrlich
Basically, if a drug or device company controls or has strong financial influence over a third party, the content must be submitted and reviewed by FDA. Obviously, a company owned website requires full disclosure to FDA on content. On the other extreme, a company just advertising on a third party site is not responsible for the content. The grey area is where a company provides financial support or writes the content itself for a third party.
This guidance is really no different than what is used as the standard for print or broadcast. If a drug company is the sole sponsor of a third party printed supplement, magazine, or broadcast show then FDA would likely consider that a drug company promotion . They are using the same standards for websites or other Internet communication. If you as a drug marketer use a third party to publish content, the measure of influence is critical. If your company pre-screens the third part material FDA considers that as your content.
If your website is dependent on a drug company for advertising, the FDA would probably look at any content as company driven. The middle ground is where interpretation can be difficult. What if there were two main sponsors? Is that undue influence?
What is missing from the guidance is any differentiation of what consumers can do with the Internet versus print or television. Most industry media people wanted some new standards so that it is not required to do all the disclosure for ad words or short teases for a product. In other words, given the power of clicking for more information and the ease of doing so, do advertisers need to put all the fair balance in the main body of the ad? There is no lessening of those traditional standards. AstraZeneca cannot say for example, “Try Crestor for High Cholesterol, click here for risks and side effects.? The interesting thing is Google can say brand name and indication and does that right below the Crestor ads.
I think the guidance is helpful in how to determine what constitutes drug company influence over third parties. On the other hand, media companies were hoping that FDA could recognize that with so much information available on the Internet, is it really necessary to treat the Web like Print? Interactive media can provide so much depth immediately that consumers do not need to see it all on the first page. It would have been helpful to recognize that consumers are quite adept at accessing additional information and will do so if they have questions. FDA says the law is the law and that law is from the 1970?s. So I do cut them some slack as they are caught between the reality of modern media and an old law. FDA did interpret the law, however, allowing television ads, in their 1997 guidance, to be done in a 60-second time frame. I would think they can go further in allowing drug companies to tell consumers about products on social media.
I can agree that drug companies should not be allowed to make any efficacy statements without risks being added. I am only suggesting that FDA should allow brand name and indication with an immediate click button for side effects and risks. That would seem to be a reasonable compromise.
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