Old Standards for New IT

In addition to lobbying for PDUFA, pharma companies are anxious to gain clarity from FDA on how its rules on drug marketing and promotion can fit the age of instant Internet communications and unfettered public access to information previously limited to health professionals. Although much of the world now uses the Internet to communicate with friends and relatives, to market goods and services, and to announce important developments around the globe, pharmaceutical marketers are stuck in regulatory limbo due to curbs on what they can tell the public about their products and operations.

After extensive discussion of social media uses and formats, FDA's Office of Prescription Drug Promotion (OPDP) within CDER now plans to develop several guidances on "concepts that have long-term applicability," said Jean-Ah Kang, OPDP assistant to the director, at CBI's January Pharmaceutical Compliance conference in Washington, D.C. Instead of issuing platform-dependent policies that would apply to posting information on, say, Twitter or YouTube, which could become outdated quickly by changing technology, the agency is looking to address broader Internet communications issues. These include messages with space limitations as found in banner ads or social media listings; manufacturer accountability for online communications; links to Internet websites; correcting misinformation on third-party websites; and how to notify FDA of a real-time communications activity.

Less Off-Label Prosecution

Most contentious is FDA's proposal that manufacturers handle requests for information made in public or via the Internet the same as queries made in writing, by email or the phone: provide a response only to the individual requester in "a private, one-on-one communication"—and not online. The agency's concern is that a public response exposes those not making the query to off-label information, and that such messages could remain on a website after they become outdated. When receiving an unsolicited request on an issue related to off-label use, FDA advises companies to provide contact information to medical or scientific personnel (not salesmen) and direct the individual to follow up off-line. However, this means that a broad audience can see a query and any resulting independent statements, which could be erroneous, but not the company's answer.

Such communications restrictions raise concerns about broader limits on industry use of modern IT for a broad range of corporate and operational functions, such as reporting corporate news and developments, recruiting patients for clinical trials, or operating hotlines to receive consumer questions and comments. A hot topic is utilizing social media to expand public reporting of adverse drug events. Pharma companies are leery of having to scour Twitter and Facebook to identify such reports and respond to them, which could be a monumental task. But the larger problem is that manufacturers still could be constrained from addressing misleading AER reports, particularly if they touch on off-label use.

Additional guidance on pharma use of social media to communicate information may take some time because OPDP is under pressure to develop policies on a number of drug marketing topics. The agency checked off one item by publishing draft guidance in January on product name placement, updating a 1999 policy. A top priority on its to-do list is to implement a program established in 2007 for providing timely pre-review advice on direct-to-consumer TV ads. And work continues on the seemingly endless task of revising the "brief summary," now likely part of a larger effort to establish a common format for multiple patient information documents.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at jwechsler@advanstar.com