Industry will ring in the New Year with no more guidance from FDA on Internet and social media promotion than the warning and untitled letters that FDA has issued during the past several years.

Despite earlier expectations of a December release, FDA now plans to issue draft guidance during the first quarter of 2011. The agency is promising only that it will deal with at least one of the issues that has deterred drug companies from full use of the Internet's marketing capabilities. Division of Drug Marketing, Advertising and Communications Director Thomas Abrams had predicted in October that the first of two or more draft guidances would be available by the end of 2010 (Also see "FDA's Internet Promotion Guidance: One Down By Year-End; Four More To Go?" - Pink Sheet, 18 October, 2010.).

Focus Of Internet Guidance

Six topics head the list of areas FDA will address in one or more draft guidances to help sponsors navigate Internet and social media promotion and the perils of an interactive environment. These are:

Responding to unsolicited requests
Fulfilling regulatory requirements when using tools associated with space limitations
Fulfilling post-marketing submission requirements
Determining online communications for which manufacturers, packers or distributors are accountable
Use of links on the Internet
Correcting misinformation

What's interesting about the delay is not so much that guidance development has been pushed back (that's an unfortunate fact of life at FDA), but that the delay happened so soon after Abrams announced a target release date. FDA is not talking about the reasons behind the delay. Events suggest Internet promotion remains a high priority for the agency (hence the public announcements) and FDA's thinking on the issue may have evolved recently (hence the last-minute delay).

The latter is not comforting for industry, which would value the certainty even a strict policy would bring. Marketers can take solace, however, in the fact that FDA continues efforts to formalize its approach on a wide-range of Internet issues.

The agency is looking at six areas for coverage in the guidance, but is remaining coy about where its focus is. "We cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed," FDA said in an e-mail.

FDA also has not specified how many guidances will be developed to lead sponsors through the interactive environment of the Internet. Uncertainty about sponsors' responsibility in an arena they do not control was a major concern of stakeholders during a 2009 FDA hearing on medical product promotion on the Internet and in social media (Also see "Who's Liable For Online Content? Pharma, Marketers Disagree (Slightly)" - Pink Sheet, 30 November, 2009.).

Letters From Abrams

While they await the formal document, marketers must continue to make due with advice they can glean from the letters that FDA has sent over the past few years citing firms for violations in their Internet activities. This collection of correspondence is not gift-wrapped guidance under the tree, but neither is it a lump of coal in the stocking.

Better to think of all those letters as an extended holiday message from Abrams.

One thing drug companies can be certain of is that risk information should accompany a presentation about a drug's efficacy and/or indication.

FDA triggered the quest for Internet/social media- specific guidance when it wrote 14 drug makers in April 2009 that risk information must accompany efficacy information, specifying that a link to risk information is insufficient, and has continued that train of thought since. The companies received citations for websites discussing 48 products (Also see "Internet Searching May Get ‘Riskier’ For Patients After FDA Citations" - Pink Sheet, 6 April, 2009.).

Since then, DDMAC warning and untitled letters have delivered the same message – risk information must be given along with efficacy claims, regardless of linkage or format considerations.

In some cases, the division said risk was not given placement or a format of equal prominence with efficacy. In others, DDMAC continued to dismiss the adequacy of a link.

Promotional materials "must contain risk information in each part as necessary to qualify any effectiveness or safety claims made in that part," DDMAC explained in a March 24, 2010 warning letter to Slate Pharmaceuticals for its Testopel Pellets (testosterone).

Links to safety information on pages about efficacy "do not mitigate the misleading omission of risk from these pages," the division wrote.

The inadequacy of a link to risk information also was a problem for a widget developed by Novartis to allow patients to post a link to information about Tasigna (nilotinib) on their Facebook pages. The information fails to disclose any risk for the oncologic, although it has a hyperlink to various Tasigna websites, DDMAC said in a July 29, 2010 letter.

"Inclusion of such a hyperlink is insufficient to mitigate the misleading omission of risk information from these promotional materials," the agency said (Also see "DDMAC Dislike: FDA Cracks Down On Facebook Widget Used On Tasigna Website" - Pink Sheet, 5 August, 2010.).

Videos embedded in websites are not immune from the requirement that risk must accompany efficacy where it is discussed, according to DDMAC.

Patient testimonial videos on the homepage of Premarin (conjugated estrogens tablets) drew an April 12, 2010 untitled letter for Wyeth because there were no risks mentioned in the audio/visual presentations.

"Risk information for Premarin is relegated to the bottom portion of the webpage below the testimonials in read-only text format, where it is unlikely to draw the viewer's attention," DDMAC said.

This "fails to convey this important risk information with a prominence and readability reasonably comparable to the claims of effectiveness."

By Cathy Dombrowski

FDA's Internet Promotion Policy: Christmas Cards In Lieu Of Guidance?

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