The US Food and Drug Administration has issued a first guidance for drug and medical device companies to use when posting information about products on internet platforms with strict limits on the number of characters allowed.
Such platforms would include the microblogging site Twitter, which limits posts to 140 characters, and the sponsored links that appear with Google and Yahoo search results.
In the case of drugs, for example, the FDA said that such posts should include the brand and chemical name of the drug, and, if the post makes a claim of benefit, must also present the drug’s most serious risks.
The presentation of risks and benefits should be balanced and should be included in the same message, the FDA said. For example, a 134 character “tweet” on Twitter for a hypothetical memory loss drug called “rememberine hydrochloride,” marketed under the brand name “NoFocus,” might read: “NoFocus (rememberine HCl) for mild to moderate memory loss—may cause seizures in patients with a seizure disorder www. nofocus.com/risk.”
The FDA said, “In the above example, benefit information for NoFocus is accurate and non-misleading, and the most serious risks associated with NoFocus are communicated together with the benefit information within the tweet.”
Sponsored links on Google allow for a URL of up to 35 characters, with an additional 70 characters of explanatory text. In addition to the main link the listing may have six additional links to related information, called “Sitelinks.” Each of these Sitelinks must be 25 characters maximum and may be accompanied by an additional 35 characters of text.
As an example of an appropriate sponsored link the FDA created “ouchafol,” a hypothetical drug for severe headaches associated with traumatic brain injury, marketed as “Headhurtz.” The package insert for this hypothetical drug included a boxed warning about potential brain swelling, as well as warnings about fatal drug reactions and life threatening drops in heart rate. In this case, the FDA said, the main sponsored link might read: “Headhurtz (ouchafol)” with the link www. headhurtz.com, accompanied by the text “For severe headache from traumatic brain injury.”
The main link would then have four related Sitelinks below it, each taking readers to web pages with risk information—in this case: a “Boxed Warning” link with the text “Potential for brain swelling,” a second “Warning” link with the text “Potentially fatal drug reaction,” another “Warning” link with the text “Life threatening drop in heart rate,” and a fourth “Risk information” link with the text “Important safety information.”
The FDA commented, “If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character space limited communication, then the firm should reconsider using that platform for the intended promotional message.”
A second guidance document from the FDA2 provided advice to drug and device companies that voluntarily decide to correct misinformation posted about their products—positive or negative—by an independent third party who is not under the company’s control or influence. Such corrective communications, the FDA said, should address the misinformation but should be limited to the misinformation, be “non-promotional in nature, tone, and presentation,” consistent with FDA’s required labeling of the product, and disclose that the person providing the corrective information is affiliated with the firm.
“FDA does not expect firms to submit corrections to the agency when correcting misinformation pursuant to this draft guidance; however, FDA recommends that firms keep records to assist in responding to questions that may come from the agency,” the guidance said.
Both guidance documents are open for public comment for 90 days.