For almost five years, the pharmaceutical industry has essentially held its collective breath waiting for guidelines from the U.S. Food and Drug Administration on how it should operate on social media and the Internet. Out of a public hearing held in 2009 with pharmaceutical companies and medical device makers, five pressing questions were posed by the FDA’s Office of Prescription Drug Promotion (OPDP).
While insight has come from time to time through the issuance of some guidance documents and through the issuance of some untitled letters, the June OPDP release added substantially to the body of knowledge with the issuance of two draft guidance documents — one on social media platforms with character space limitations and one on correcting misinformation posted by third parties.
While shedding light on these two important areas, there are still questions outstanding from the 2009 meeting, particularly related to adverse events. There also is the totally uncharted territory in dealing with mobile, which wasn’t even a factor five years ago. Given how important mobile has become at medical meetings, one might expect or at least hope that will be the next target for the OPDP.
In reviewing the guidances, there are some definite surprises.
Correcting Third-Party Misinformation
- One big surprise: Companies CAN correct misinformation on third-party sites.
“If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising…” Until now, many firms believed that correcting misinformation on a third party site was not an option. Apparently now it is, according to the OPDP.
- The FDA provided specific recommendations for making corrective comment.
Corrective comment has to be relevant and responsive to the misinformation and tailored to it specifically. A corrective message should apply to the indication being discussed in the original commentary, not additional indications for the product that were not mentioned. It must not be promotional in nature, tone or presentation and must be accurate and consistent with the label, supported by evidence and should disclose that the person posting the correction is affiliated with the product manufacturer. These are the standards by which a correction will be assessed by FDA.
- Companies are responsible for content on their own site, but not necessarily if it is generated by an independent third party. No initial surprise here as I think companies understood that they are responsible for content that they generate. But here is a point made by the OPDP which most companies may not have understood before: “Firms are generally not responsible for third-party UGC (User Generated Content) about their products…regardless of whether the firm owns or operates the platform on which the communication appears.” But what if the third party participant begins to discuss an adverse event? On this the guidance is silent. Presumably the answer may be the subject of another guidance yet to come, but I believe that most in industry would not hold such a discussion on their corporate site in the first place, so the example may not be the best in the first place.
- Companies are not obligated to correct misinformation. TheFDA also uses an example of a blogger supplying misinformation and states that a “firm may decide to attempt to correct misinformation, but is not obligated to attempt to correct it.” That raises an interesting point. If a firm decides to correct misinformation, it must follow to the letter the procedure for doing so. This introduces risk of a misstep. If however a company is not obligated to correct, then it can avoid that risk by letting the misinformation stand. Thus, in an effort to address a public health concern, the guidance may have overlooked this inadvertent discouragement to make sure the most accurate information is everywhere.
- Correcting a part of a website does not obligate a company to correct the entire website. A company should correct all of the mistakes in a posting, but in doing so, is not then obligated to correct misinformation that appears on other pages of the site, according to the guidance. To many, this will be welcome news.
Social media on platforms that limit characters or space for full risk and benefits explanations
Well, the title alone—“Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” is over the 140-character limit of Twitter, so one can see that the OPDP and the industry have a pretty daunting task ahead. The problem gets thornier when a pharmaceutical company has to include risk information, along with a drug’s benefits.
Previously through regulatory action letters, the OPDP has taken the position that inclusion of the risk information by link alone isn’t sufficient. In other words, if the FDA would tweet a drug approval – “XYZ Drug approved by FDA for diabetes Type 2″ – the manufacturer would presumably not be allowed to re-tweet the FDA’s announcement. After this guidance, nothing much has changed.
The agency sets up some hypothetical example to construct a tweet using a fictitious drug called NoFocus, which is indicated for mild to moderate memory loss. The complete profile of the product: It has no boxed warnings and no known fatal or life-threatening risks in the drug’s label. The most serious precaution is that it may cause seizures in patients with seizure disorder. The chemical name of NoFocus is remembrine hydrochloride. (Since scientific abbreviations may be used for a chemical ingredient, it could be written as HCI instead of hydrocholoride, a plus in a tweet.)
Now, how does that translate into a tweet in compliance? Here is the example FDA provided: “NoFocus (remembrine HCI) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.comrisk” — a little under the 140-character maximum of Twitter. While presumably you could cut this down by making patients “pts” and making with “w/”, there is essentially little to no room left for any news, such as including the words “FDA approves” or a link to the press release announcing the approval. You might get away with “FDA OK’s” as language, but the point is that this is a very tricky proposition.
Twitter is a news forum and therefore needs to include news; the way that the FDA has constructed it, the tweet is more like an advertisement for the drug — and a not very good one. Moreover, how many drugs would have such an abbreviated list of risk factors, short name and short link to risk factors to mimic this somewhat tortured example? The NoFocus tweet, which would require a lot of review internally by a company to ensure compliance, also could backfire with such an extensive concentration on the risk. In essence, there really is no change on guidance about using social platforms that restrict characters.
In the end, that may be the lesson that we can take away from both of these FDA guidances. After such a long wait, little may have changed. While technically firms are allowed under the first guidance to correct misinformation, there is regulatory risk if the parameters for doing so are not met. Thus, the most conservative course of action is to not correct. And Twitter and its 140-character tweet still appear to be more trouble than it’s worth.
At the end of the day, the guidances confirm what the industry can’t do but still leave many unanswered questions about what it can do. Here are just a few: What can we expect about space limitation in optimization for mobile? What should be done if the User Generated Content contains an adverse event? What are the rules of search engine optimization?
As we get answers to questions, it is inevitable that more questions will arise signaling a long process for establishing clear guideposts for the Internet and social media use by industry.