The FDA has, at long last, released draft guidance for and .
The FDA carefully controls labeling, advertisement, and promotion for drugs and devices requiring FDA clearance. It makes sure that companies never list the benefits of a drug without also disclosing its side effects and that drugs are advertised only for uses for which they have been approved. The internet has complicated those regulations.
For instance, in cases where pharma companies wish to use Twitter, it has been unclear whether they can string the required information about a drug over several tweets, or whether each tweet constitutes a separate communication from the company. Additionally, when drug companies encounter misinformation posted on the internet and want to correct it, is that correction bound by all the same requirements as an advertisement or an official company statement?
The new draft guidance, presented in the form of two documents posted to the FDA website, attempts to address these concerns. Although the guidelines are non-binding guidance documents, they should go a long way toward clarifying for drug manufacturers exactly how much care they have to take in online communication. Here are the key takeaways from the documents, which are now open for public comments.
1. Each tweet must include both benefits and risks
According to the new guidance on social media with character limitations, if a company wants to tweet about the benefit of a drug, they must include the "most serious risks" of that drug in the same tweet. The FDA defines the most serious risks this way:
"For a prescription human drug, the most serious risks would generally include all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling (PI). If a prescription human drug does not have a boxed warning, fatal or life-threatening risks, or any contraindications, the most significant warnings or precautions about the product should be communicated."
2. Each tweet must be complete and accurate
Pharma companies also have to be clear about the primary indication of the drug, and can't abbreviate in a way that would be misleading. So a drug "for severe headaches from traumatic brain injuries" couldn't just be abbreviated "for headaches," for instance. They also have to include the generally accepted use name of a drug along with the brand name, just as they're currently required to do in other channels.
3. Each tweet should include a hyperlink to a more comprehensive list of risks and side effects
If possible, this should be an unambiguous URL like "product.com/risks." In any event, a link to the company about page or a landing site for the drug isn't enough: The FDA recommends a direct link to a dedicated page providing risk and side effects information about the drug or treatment in question. This restriction and the previous one apply to not just Twitter and similar platforms, but also to online paid search advertisements, which also have a character restriction.
4. If it doesn't fit, don't tweet it
The FDA urges companies to carefully consider whether Twitter is the right platform for communicating the benefit of a given drug, and to avoid it entirely if the above criteria can't be met. This isn't the best news for anyone hoping the new guidance would make it easier for pharmaceutical companies to tweet.
5. Companies don't have to correct misinformation about themselves on the web, but they can
As long as information is on a website that's not controlled by the company, the FDA does not mandate that companies police the internet for misleading content about their products. But if they do, and they chose to correct it, they will be held to certain standards.
6. Companies must correct the good along with the bad
Any correction a pharma company posts, whether in a forum or chat room, as a comment on a blog post, or submitted via email to a blogger or website administrator, has to correct all misinformation in a defined field -- and define that field. So if an article contains a piece of misinformation that makes a drug look bad (say, overstating the side effect risk) but also misinformation that is positive for the company (overstating the effectiveness) the company is required to correct both those pieces of information. On the other hand, posting to one discussion in a message board doesn't obligate a company to read the entire message board looking for other errors. When they post their correction, however, they should indicate that they're only correcting within this single discussion.
7. Corrections must be limited in scope
When correcting information, the FDA recommends that those corrections be "limited and tailored to the misinformation" and "non-promotional in nature, tone, and presentation." In other words, stick to correcting the facts and don't take the opportunity for a sales pitch. They also recommend the correction include a link to the official FDA-cleared labeling page for the product, and that the poster clearly identifies themselves as being affiliated with the company.
8. Keep records of corrective interactions
Pharma companies won't be held responsible if they reach out to an online content poster and ask for a correction if they are ignored. And the FDA won't require companies to submit documentation of corrective actions as they go. But they do encourage companies to keep track of any such actions they take, so that if the FDA takes an interest in the future, the company can easily respond to inquiries.
Last January, an IMS report found that the current state of pharmaceutical engagement on social media was pretty abysmal: Half of the top 50 pharma companies didn't use social media at all, and of those that did, most were minimally engaged. At the time, healthcare consultant Paulo Machado told Babyforyou.net.ua that the lack of clear FDA guidance was a big reason pharma companies were staying out of the social media game, but even if guidance cleared it up, many companies might not judge social media to be worth the risk.
The guidelines do clear up some very specific social media concerns, but don't really address others, such as whether having a public Twitter opens up pharma companies to report any negative tweet about their product as an Adverse Drug Reaction. A group of researchers recently dug into this data and discovered Twitter often had three times as many ADRs for a given drug as the FDA, though they were less reliable and often difficult to parse.