“It doesn’t turn me on to send a warning letter.” –Tom Abrams, during a Q&A at DIA.
Instead of repeating his yearly Drug Information Association (DIA) conference claim that social media guidance remains among the FDA’s Office of Prescription Drug Promotion’s (OPDP) “highest priorities,” to be published in due course, Tom Abrams, director of OPDP, had real news to discuss this time around: two new draft guidances (on correcting misinformation online, and on presenting benefit/risk in character-limited digital channels) had been published that very morning, June 17, both of which deal with important social media concerns for industry.
Unlike his co-presenter, former DDMAC head Lucy Rose, Abrams wasn’t ebullient or celebratory on stage. (Rose, who was both, worked the crowd with a microphone she used as a scepter to project faux-rhetorical questions onto unsuspecting attendees.) Instead, Abrams seemed to anticipate what was to come during the Q&A: a flood of hypothetical scenarios from the audience, and the inevitable charges, almost within minutes of the guidances’ release, that OPDP wasn’t being clear enough about what a pharma company can and cannot do in the social media realm.
Abrams emphasized that companies should always identify themselves in social media, and if they use social media outlets as promotional channels, they should submit, on a monthly basis, the name of the site, the URL, the date range of activity, and a cross reference of the last submission date.
PharmExec duly joined the queue of question-askers. Here are four of the questions and answers raised at the end of the presentation:
Q: If a company corrects misinformation on a third party site, does it have to submit that correction for OPDP review?
A: No. But FDA does recommend that companies keep records that include, for example, the “content of the misinformation, where it appeared, the date it appeared or was located, the corrective information that was provided, and the date the corrective information was provided.” Companies should not correct misinformation with promotional statements. If they do, those statements would be considered advertising and subject to applicable review by the agency.
Q. Correcting misinformation is voluntary, but the guidance says companies that do choose to correct misinformation must correct positive and negative information. To what extent must a company look through a whole website or number of sites to make other corrections once they’ve made one correction?
A. Companies are only responsible for the “clearly-defined portion” of a given webpage or forum where a correction(s) is made. “We aren’t going to look around and see if you aren’t correcting positive misinformation [overstated efficacy, for example] on other web sites” or outside of the designated section, said Abrams. However, if one correction is made, the company is responsible for correcting all brand information within that designated section, positive or negative.
Q. What about Wikipedia? The English language version is read in the UK and other places, so how do companies correct misinformation in light of different labels in different geographies?
A. “These are not easy issues,” said Abrams. In the case of adverse events reporting, Abrams advised getting in touch with Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology.
Q. How can products with complicated risk/benefit profiles and labeling be expected to include sufficient examples of both in a tweet?
A. Lucy Rose: Let me ask you a question. Your product information requires a 7×9 print ad, and your sales team would really like to use a 7×4 instead, but you can’t fit all of your risk information on a 7×4. Can you use a 7×4 ad? No, you can’t. You need to use a 7×9. Some products won’t be able to use Twitter as a promotional channel. From the guidance: ”At a minimum, a firm should communicate the most serious risks associated with the product together with the benefit information within the individual character-space-limited communication.” 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.”
Of course, comments are welcome on both draft guidance documents, via the Federal Register, by September 16. Draft guidances are not binding and will take into consideration any comments submitted prior to issuing the final rules, according to FDA procedure.
In an analysis of the guidance documents, Justin Freid, VP, search engine marketing and emerging media, at Communications Media, Inc. (CMI) – a strategic media planner and marketing partner for the pharma and healthcare industry – wrote that CMI’s recommendation to clients is to “never make a product benefit claim within a paid search ad.” Asked whether the two new guidance documents (and the three others released by OPDP earlier this year that address specific biopharma social media practices) make good on FDA’s years-long deliberation, Freid said, in a word, no.
“At this time, I do not believe the guidance provided by the FDA is enough to make pharmaceutical companies feel completely comfortable with utilizing social media,” wrote Freid in an email. “The largest fear of pharma companies is the potential need to respond immediately to complaints or misinformation in a social network.”
Freid said the “thought of an engagement where users expect real-time answers is still frightening” to pharma, since promotional materials require extensive in-house legal and regulatory review. “The connection time between creative agencies, media agencies, brands and legal and review teams will need to speed up significantly,” he said.