The Food and Drug Administration last week issued two draft social media guidelines designed to help drug and medical device makers and their representatives accurately communicate on social media networks about their FDA-approved products.

The first draft guidance provides drug and medical device makers and distributors recommendations as to how to communicate both benefit and risk information about FDA-approved products specifically on social media networks that have character space limitations, such as Twitter.

When using social media platforms with character space limitations, the FDA recommends using the following approaches:

Communicate both the proprietary (trade or brand) name and generic name, with the generic name listed directly to the right of, or directly below, the brand name;

Include both the benefits as well the “most serious” product risks;

Use bold formatting, where possible, to highlight significant risks; and

Use hyperlinks to send users directly to risk information.

In its guidance, the FDA offered an example of a hypothetical memory loss drug, NoFocus. Using that example, the FDA stated that an acceptable tweet could read: “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk”

The guidance doesn't apply to promotions made through product websites, individual web pages on social media networks—such as Facebook, Twitter, or YouTube—and online web banners. According to the FDA, these types of social media platforms don't impose the same character space constraints as online micro-blog messaging.

The FDA warns that some products may be too complex to advertise on social media platforms with character space limitations. “For some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk,” the proposed guidance stated.

“This is an important caveat,” states a client alert from law firm Reed Smith.  “The vast majority of prescription drugs have risk profiles that are far too complex to fall within FDA's new draft guidance.”

Correcting Misinformation

The second draft guidance describes how to correct misinformation about a drug or medical device product posted by independent third parties. Citing a series of 15 examples, the FDA describes in the guidance what types of communications qualify as “misinformation,” and sets forth several approaches for voluntarily correcting such misinformation about its own products.

The FDA said it recognizes that the Internet, social media, and other technological venues contain a vast amount of information and even one particular forum might have a large quantity of information. As a result, it may be difficult for companies to correct all misinformation about its products in one forum, the FDA said it doesn't expect each piece of misinformation in an entire forum to be corrected.

“However, a firm should clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and should correct all the misinformation that appears in that clearly defined portion,” the FDA stated.

If a company chooses to correct misinformation, it may do so directly on the forum, or provide the correct information to the author to fix, according to the draft. The FDA said it will not hold a company accountable for an independent third-party's failure to correct misinformation.