Potential of One Click Rule to Change Pharma Marketing

Executive Summary

A bill currently in the House of Representatives dubbed the “One Click Rule” would allow ISI information to be included via a link, rather than within the ad. This could have major implications for the potential pharma brand use of social media marketing, bringing us a step closer to being able to have freer conversations with those that need our products.


Each day, millions of people head to social networks to share and gather information related to their health. From large networks like Twitter and Facebook, to niche disease state specific networks, the opportunity to connect and engage with your audience is unparalleled.

Over the past few years, we have seen pharma becoming more comfortable with social media. Many companies leverage social profiles across the major networks for corporate initiatives, while others have leveraged groups for HR and internal communications.

More progressive organizations have also had some success engaging communities with unbranded or disease state specific content. As a whole, the industry has been hesitant to adopt comprehensive social strategies from a brand perspective, often because of regulations.  However, with the introduction of a new house bill, that may be about to change.

On May 20th, Missouri Republican Billy Long introduced a bill to the US House of Representatives to amend the Federal Food, Drug, and Cosmetics Act.  The bill (H.R. 2479) would allow Pharma companies and marketers “to disseminate in character-limited applications, truthful, introductory information about medial products, including the name of such products and their approved uses.”

Most importantly, the proposed legislation would treat hyperlinked information from a regulatory perspective as if it were included within the content.  This would green-light what is known across the industry as the “one-click rule.”

One-Click Rule

Whenever a brand and the disease state it’s indicated for appear within the same content, the ISI must be present. This has made it extremely difficult to leverage character-limited social networks like Twitter. Based on current FDA regulations, brands are very restricted in what they can and cannot do for DTC and HCP focused social efforts. As you can imagine, the average ISI is much longer than Twitter’s 140 character limit.

This “one-click rule,” pending approval from US legislatures and revisions from the FDA, would permit advertisers to include the full prescribing information and safety concerns of a medical product (drug, biological product, or device) through a direct link, rather than in its entirety within the ad content itself.

As long as the presentation and fair assessment of risks and benefits of a product is a single click away, the proposed bill would have the FDA view the content as permitted and fairly balanced.

Legal Precedent

Long desired by pharma marketers, this legislation is not without precedent. While not in oversight of pharma advertising, ceding that responsibility to the FDA, the Federal Trade Commission (FTC) passed a similar bill in 2013.

On March 12, 2013 the FTC published a revision to their Dot Com Disclosures stating that “when it is not possible to make a disclosure in a space-constrained ad, it may, under some circumstances, be acceptable to make the disclosure clearly and conspicuously on the page to which the ad links.”

Although not pertaining to pharma, this update rocked the boat in the industry all the same with conjecture on how a similar FDA bill would open up social media advertising to branded efforts.  Two years later, and this landmark legislation is finally up for discussion.


Long’s bill would allow the FDA six months to revise the draft of the proposed bill, and 18 months to adopt these final regulations.  While not requiring immediate action, this activity has rightfully put the Pharma industry on notice.

The adoption of “one-click” legislation would open up an incredibly large and engaged market to promote specific drugs toward.  Pew Research indicates that 74% of online adults use social networking sites. Twitter alone – the originator of character-capped media – has over 302 million active monthly users.

How Will This Bill Affect Pharma Brands?

If the FDA regulations were revised, the largest change would be in relation to the content brands are able to share and promote about their brand and the indication. Currently, most short form social updates stay away from mentioning the disease state. This change would allow more flexibility for brands to control what content they decide to share or include in their profiles on social networks.

With clearer, more defined guidelines, legal and regulatory teams also would have a better understanding of what brands can leverage from a social perspective. This could help with any current hesitation caused from the lack of clarity the FDA has provided with past social media guidance.

With this bill and the additional guidance provided, brands will have more freedom to help people achieve better health outcomes by building stronger, more interactive relationships with the people who use their brands. Social media has grown so significantly, the average consumer expects brands to engage and respond with valuable information. If this bill passes, the pharma industry will be one big step closer to living up to those expectations.