As we previously noted, waiting for FDA to issue social media guidances was a little like Waiting for Godot.
Well, Godot has returned and FDA finally released two long awaited draft guidances relating to social media, one relating to the presentation of risk information and one relating to correcting misinformation. These are so overdue, that if they were library books, FDA would have had its library card revoked years ago. FDA initially promised these in 2010.
If I were to tweet a summary of FDA’s recently released draft guidance titled “Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” (the “Risk Guidance”) it would be a very brief tweet, well within the maximum 140 characters: “FDA to industry: Nothing’s changed #stuckin20thcentury”. The Risk Guidance can best be summed up by FDA’s statement:
Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product. (Risk Guidance at 5).
In other words, each tweet or sponsored link needs to incorporate whatever claims the company wishes to make (which must be accurate and non-misleading) as well as risk information (including all risk concepts from a boxed warning, all risks known to be fatal or life-threatening, and all contraindications from the approved product labeling.) Each tweet would also need to include a hyperlink that links to a more complete discussion of risk information. Note that the link cannot lead to a promotional webpage or even the product labeling, but rather must lead to a page that is (hopelessly) “devoted exclusively to the communication of risk information about the product.” (Risk Guidance at 10). FDA encourages companies to use links that make it clear that it leads to risk information, although it will not object to URL shorteners, such as tinyurl or bit.ly. FDA does permit additional links to be provided, such as to the product homepage or PI, assuming there’s enough room.
Ok, so that’s fine, right? Still plenty of room to make promotional claims? Not so fast, sport. Additionally, FDA requires companies to include both the proprietary and established names for drugs within the tweet or sponsored link. Then, on the hyperlink to the risk information mentioned above, the communication should include both the brand and established name, as well as at least one dosage form and quantitative ingredient information in conjunction with the brand and established names. In a nod to teenagers everywhere, FDA acknowledged that commonly recognized linguistic symbols may be substituted for words, such as “&” for “and”, as well as abbreviations, such as HCl for hydrochloride. However, FDA did not address the use of emoticons or LOL and OMG. ;)
FDA’s example of a permissible tweet is “NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk”. (Risk Guidance at 14). Six characters to spare! And this is a drug that has very few risks, apparently. Similarly, for an example of a Google sponsored link, three of the six links in the ad that lead to specific parts of the promotional website deal with risk and safety information. The real takeaway from this Draft Guidance comes early on, when FDA states: “If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion).”
Leaving the snark aside (temporarily, we still have another draft guidance to get through!), what FDA is saying is that each space-limited communication needs to adhere to the rules relating to promotional labeling. This is no real surprise. While those of us who watch the issue closely would have liked to have seen some out of the box thinking and creativity, this draft guidance is consistent with advice that most regulatory attorneys and consultants have given (see Wasserstein, The Regulation of Social Media: Whither FDA? at 7-9 in Using Social Media in FDA-Regulated Industries: The Essential Guide (FDLI 2010). The Risk Guidance doesn’t open any doors, but it might make companies that have drug or medical device products with relatively simple risk profiles more comfortable in tweeting very basic product related tweets. Alternatively, the benefits claims can be broken up into multiple tweets, provided each is accompanied by the appropriate balancing information, product names, and hyperlinks.
Turning now to the draft guidance titled “Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” (we’ll call this one the “Misinformation Guidance”), we encounter a little more flexibility from FDA. In the Misinformation Guidance, FDA makes clear that companies do not have obligations to correct misinformation created by third parties, often called User Generated Content, or UGC. However, if a company voluntarily corrects misinformation in a truthful and not misleading manner, FDA will not object if the corrective information does not satisfy other regulatory requirements regarding labeling and advertising. (Misinformation Guidance at 3). In other words, if a firm corrects misinformation about the indication or efficacy, but does not include any safety or risk information, FDA will not take regulatory or enforcement action.
The first question addressed is whether the draft guidance applies to the correction of misinformation. FDA makes clear that the draft guidance does not apply to corrections of misinformation made by the company itself or to UGC on a company-moderated and controlled discussion group, such as where the company removes or edits negative posts about its products and adds positive commentary. The company, by doing so, has exerted control over the UGC. However, FDA clarified that companies are not responsible for correcting misinformation found in UGC about their products when the UGC is truly independent of the firm. When FDA made a similar statement in a prior draft guidance relating to submission to FDA of real time social media interactions, we noted that “this does not address the issue of whether a regulated company would need to correct misinformation or off label discussions placed on site or platform controlled by the company.” Either we are more widely read by FDA than we thought, or FDA had already been thinking along the same lines, so that issue has now been laid to rest.
So, what can companies do to correct misinformation in a way that need not comply with promotional labeling and advertising regulatory requirements? In brief, they should address the misinformation and not use it as a springboard to engage in promotional messaging. The correction should be posted in the same area or forum or should reference the area where the misinformation is found. Companies can either post directly (if permitted) or notify the site owner of the misinformation. In all cases, the company should disclose that the person making the communication is a company employee. Although risk and other information about the product isn’t required to be included in the correction if not relevant, the approved PI should be included either via PDF or a link to the approved labeling. The correction should be limited to the scope of the misinformation.
Companies have often been reluctant to monitor third party sites lest they be held responsible for all the content on the site. FDA stated that if the company is correcting misinformation in part of the forum or site, it should identify the section of the forum or site it is addressing and correct all the misinformation (both positive and negative) within that section. The company is not responsible for the site other than the clearly defined portion it identifies. (Misinformation Guidance at 7).
Another concern companies previously had was that once it tried to correct misinformation, would they be responsible for continuing to monitor the site? (I’ve heard that stated by FDA’ers at public meetings in the past.) The Misinformation Guidance makes clear that FDA does not expect companies to continue to monitor the website or forum. (Misinformation Guidance at 8).
Finally, FDA does not expect companies to submit corrections of misinformation to FDA, but does recommend that companies keep records in case FDA has questions. The records should include the content of the misinformation, where it appeared, the date it appeared, what corrective information was provided and when the corrective information was provided.
Companies have 90 days from the date of publication of in the Federal Register to provide comments to the draft guidances (written or electronic submissions are both permitted, but not tweets). So, if you don’t have any exciting summer plans, this summer might be a good time to submit comments on these draft guidances!