Regulatory Focus™ > News Articles > Waiting for Godot (and Guidance): Social Media Policy 'Among Highest Priorities' at OPDP, Says Abram

Waiting for Godot (and Guidance): Social Media Policy 'Among Highest Priorities' at OPDP, Says Abrams

Posted 18 September 2013 | By Alexander Gaffney, RAC

Advertising and promotion regulatory professionals have since 2009 waited for the US Food and Drug Administration (FDA) to issue its much-discussed social media guidance on how the agency expects them to interact with stakeholders and the public on social media channels. And according to Thomas Abrams, director of FDA's Office of Prescription Drug Promotion (OPDP), industry will have to keep waiting.

High-Priority Guidance

Appearing on a panel of FDA advertising and promotion regulatory officials at the Food and Drug Law Institute's (FDLI) Advertising and Promotion Conference, Abrams said issuance of the guidance remains among OPDP's "highest priorities."

"I know everyone is interested in our progress and where we are with respect to that," Abrams said. The good news-or bad news, depending on when you hoped the guidance would be issued-is that OPDP is working to meet a new statutory requirement passed under the Food and Drug Administration Safety and Innovation Act (FDASIA) that called for the guidance to be issued within two years of the law's passage (Section 1121). That leaves guidance to be issued on or by July 2013, though it should be noted that FDA frequently misses statutory deadlines for issuing regulations and guidance.

And notably, while FDASIA calls for a date by which the guidance needs to be released, "It doesn't affect the scope or content of the issues we're working on and continue to work on," Abrams said. Other conference attendees noted the same distinction, saying that even once the guidance is released, it may still not address all of industry's questions.

Industry has raised a number of tricky regulatory questions with respect to the use-or even simply the awareness of-social media.

For example, can a company "like" or "favorite" a statement on social media without it being an implicit or explicit endorsement of that claim? What happens if a company is made aware of an adverse event via Twitter, but there isn't enough information to track down the original reporting entity? How does the notion of "fair balance" apply when a Tweet only has 140 characters with which to explain benefits and risk information? And what happens if participants in a clinical trial use social media to talk about their involvement in a clinical trial, unblinding the results? Do companies have a duty to report adverse events not reported to them, but rather found by a marketing partner on a page that is supposed to be private?

Other Challenges

Abrams also noted the effects of budget sequestration on his office, saying his staff was grappling with "limited resources and [an] increased workload."

Despite this, "We're highly committed to producing guidance and having that guidance be well-vetted and high quality," Abrams said, adding later that he anticipates meeting the FDASIA date for releasing the guidance.

Abrams seemed to acknowledge the largely industry-dominated crowd's concern about the lengthy delays associated with the guidance, saying the agency is trying to develop something that is platform agnostic that will be useful over the long-term instead of being made irrelevant by new innovations.

When FDA began to hold formal meetings on the issuance of the social media guidance, some now-popular social media channels like Pinterest had not yet been created. Many pharmaceutical companies now use the service, as well as other more established ones like Twitter and Facebook. And the future is likely to bring other innovations and platform uses, as well. Perhaps some pharmaceutical company would want to use Snapchat-a photo sharing service that allows for photos to be deleted off the other person's device after a set amount of time-to promote products with an evolving risk profile so that they don't have to track down and delete older information.

At issue, however, is whether a platform-agnostic approach would include enough detail to account for some of the nuances inherent in the use of some social media platforms. For example, a sponsor tweet advertisement run by AstraZeneca in September 2013 was abruptly pulled after the tweets-disease awareness-included an automatic link preview that associated the disease with AstraZeneca's specific product. Even though the company had not explicitly chosen to link the two elements in the same space, the combination could potentially cause a violation under FDA standards for "fair balance" of risks and benefits relative to the indication for use.

Tags: OPDP

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