TGaS panel makes case to FDA on social media concerns
November 12, 2009 – 9:58 am by Steven NilesFDA’s public hearing on the use of social media by the pharmaceutical industry is in full swing. Med Ad News Editor-in-Chief Christiane Truelove is maintaining a live stream of Twitter posts covering the event.
TGaS Advisors, a benchmarking and advisory services firm serving the pharmaceutical industry, brought together digital marketing executives at GlaxoSmithKline, Novo Nordisk, Ortho-McNeil Janssen, Sanofi-Aventis, Shire, Takeda, and other companies to develop consensus on key aspects of FDA Guidelines on social media. Their conclusions, together with benchmark information gathered from 62 brands across 18 companies, are being presented at the DDMAC hearings today, Friday, Nov. 13, by Donna Wray, who heads the Internet and Relationship Marketing Practice at TGaS Advisors.
Ms. Wray will present the group’s consensus on adverse-event reporting in the morning session and on correcting user-generated content and regulatory requirements on language in the afternoon.
Suggestions on adverse-event reporting
Adverse-event reporting requires four distinct criteria: an identifiable patient, an identifiable reporter, a suspect drug or biological product, and an adverse experience or fatal outcome suspected to be due to the suspect drug or biological product.
According to TGaS Advisors pharma industry panel, adverse-event reporting is treated as very important by the industry, but the panel believes that adverse-event reporting across the entire Internet is impossible. Most people post anonymously for one thing, and contact information is rarely available. For another thing, the quantity of posts is simply too large to even attempt to track down details for all of them.
The TGaS Advisors panel believes that when pharmaceutical companies monitor online user-generated content, they learn a great deal. They learn about misconceptions to improve their communication and about potential problems and better methods. And this learning is good for the public health. The panel believes that FDA should acknowledge this and encourage more learning.
The panel’s suggestion to FDA at today’s hearing is that the agency should continue current adverse event reporting processes, plus encourage more use of Medwatch Online Reporting Form (3500). The agency should consider general publicity promoting the form (sponsored by the FDA or by a trade organization) and allow (but not require) pharma companies and their agents to post a single line with a link to refer to the location of the Medwatch information. For example, “To report a serious medical product problem, see the FDA’s Medwatch.”
Correcting user-generated content
When it comes to the issue of correcting of user-generated content on the Internet, the TGaS Advisors panel wants FDA to realize that content not provided by the brand is never up to regulatory standards, and even doctors don’t use “fair balance.” Within a brand, time for reviewing and correcting material is a minimum of four weeks, across pharma companies and brands. And most user-generated content has no mechanism for a “correction.”
A comment posted as a correction, meanwhile, may be placed far from the original misinformation. Wikis, which are collectively edited, are notorious for “edit wars.”
What the brand doesn’t own, it can’t ensure the quality of, the TGaS Advisors panel says. Correcting of most misinformation is not advisable and gives an air of authority to content that is not authoritative. To correct one piece may imply that the content will be monitored over time and “re-corrected.”
Meanwhile, correcting all misinformation is impossible. The number of Wikis alone numbers in the millions according to wikia.com. The average product name is mentioned in more than a half-million Web pages on the Internet today, using a Google search.
The TGaS Advisors panel recommends having an official mechanism to allow people to distinguish between content subject to FDA regulations and other content. An official “seal” would appear on brand site and with other content subject to FDA guidance. The “seals” would all link to a common page explaining 1) that FDA protects the public health through guidance for marketing, 2) what high standards marketing is held to, and 3) the important role of other sources, such as recognized medical experts
Another idea the panel has is to post way signs leading to official content. An average of 10% of brand site visitors come from Wikipedia. Wikipedia, while largely useful, has a lot of content from non-experts, and the link to the brand site is near the bottom of each Wikipedia entry. The TGaS Advisors panel suggests encouraging prominent sites to post a link to official info and allow pharma companies and their agents to post a single line or link to refer to the location of the official site, as in “For information from the manufacturer, see the official Product site.”
Adhering to regulatory requirements
The TGaS Advisors panel is also offering some ideas on adhering to regulatory requirements. When it comes to ads with very limited space, such as some paid search ads, the panel recommends the ads be either reminder or unbranded advertising. When it comes to ads with somewhat limited space, such as banner advertising, they recommend 50% of important safety information appear in final frame. And when it comes to serial media, such as online video or audio content, claim and fair balance should appear in equal prominence and at close proximity.
