The Internet and interactive social media provide an efficient, low-cost way to send messages fast to millions of people—and
to targeted patient populations. But pharma companies have been slow to take advantage of these methods, largely because of
FDA rules that control what manufacturers can state about their products. FDA has been rolling out new guidelines for using
interactive media in recent months. The new guidances clarify some murky areas, but may not make online communications any
FDA's Office of Prescription Drug Promotion (OPDP) provides some useful advice in its new advisories, which were discussed
further in an OPDP webinar July 10 (slides available at
http://www.fda.gov/). Overall, the agency sticks to its rules requiring ads and promotional messages to be accurate, not misleading, balanced,
and limited to approved uses. Because it's very hard to get full risk information into a 140-character tweet or search engine
listing, such communiqués may not fit FDA's regulatory scheme for drugs and medical products, according to a draft guidance
on using the Internet and social media platforms with character space limitations (published June 16, 2014 at
http://www.fda.gov/). There's no leeway to use icons to indicate that all drugs are risky, as proposed by industry; without equal presentation
of risks and benefits in a character-limited message, OPDP advises marketers to "reconsider using that platform," especially
for products with complex indications or serious risks.
A second draft guidance gives marketers some leeway to correct misinformation on drugs and medical devices posted on the Internet
by independent third-parties. Corrections of "user-generated content" (UGC) have to be truthful and not misleading, apply
only to messages outside company control, and should not be used as "a springboard to engage in promotional messaging," explained
attorney Jeffrey Wasserstein on the FDA Law Blog (
http://www.fdalawblog.net/, June 17, 2014). Marketers should address only the specific misinformation cited, but are not expected to continually monitor
the site and track further comments.
Marketers don't have to inform FDA of every corrective posting, but should keep a record of such communications. That advice
builds on another FDA guidance published in January 2014 that aimed to simplify how marketers should inform OPDP of Internet
postings. FDA acknowledges that presubmission is not practical for continued participation in social networks and online forums;
after initially submitting information on a website, OPDP permits companies to send in a monthly list of its postings, while
keeping records of postings on file.
But in trying to define which communications are a marketer's responsibility and thus should be submitted, this earlier guidance
raised a lot of objections from industry. Marketers complained that the guidance makes them responsible for too broad a range
of Internet postings and question whether tweets and "likes" constitute advertising or labeling—or really fall under "free
speech" that lies outside FDA rules.
A final guidance is slated to address FDA's concerns about using links to other Internet sites that discuss drug risks and
benefits. FDA has warned against connecting to off-label information, and that a "one-click" process for linking to full risk
and benefit information does not satisfy its requirements for fair balance and full disclosure.
FDA also includes on its list of social media guidances a document published in December 2011 on how industry can respond
to "unsolicited requests" for off-label information—both online and in public meetings. OPDP advised marketers to provide
answers to such questions privately and off-line, an approach that remains in effect despite loud objections that it's impractical