New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) issued June 17 do not exactly establish any new marketing policy, they do help industry to understand what is expected by the agency in several online forums, according to Coalition for Healthcare Communication Executive Director John Kamp.

“OPDP’s draft guidances covering the use of Twitter-type media with limited space and the correction of misinformation on third-party sites are largely consistent with FDA marketing policy for other media and provide little new policy,” Kamp said in a letter to Coalition members. “However, to the extent that they give the industry more regulatory certainty, they will advance everyone’s goal of increasing the quality and quantity of patient information available on social media.”

In an FDA Voice blog post announcing the guidance documents, OPDP Director Tom Abrams said that the FDA “sees social media as an important resource for industry,” but that “regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and non-misleading information about them.”

“We really see the FDA delivering thoughtful, nuanced approaches to these very hard social media questions,” according to Dale Cooke, vice president/group director, Regulatory, Digitas Health LifeBrands. “Unfortunately we also see that some of the approaches being suggested are going to make it difficult – and in many cases, impossible – for companies to engage in some of these technology platforms,” Cooke told the Coalition.

Risks/Benefits in Social Media Guidance

The first guidance, “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” provides recommendations for the presentation of risk and benefit information for drugs and devices using social media sources with character space limitations, such as Twitter and paid results links on Google and Yahoo (see CDER2012155Guidance for the full draft guidance document).

In a June 17 Regulatory Alert issued by Digitas Health, Cooke explained that it is OPDP’s intention that risk information be presented “when it is required by the presence of benefit information in the discussion of a product,” and restated FDA’s point that because of this position, “FDA emphasizes that some products will not be able to abide by the requirements … within space-limited contexts,” and for these products, the company should reconsider using that platform.

Indeed, at the Drug Information Association Annual Meeting held last week in San Diego, Abrams noted that he expected minimal use of space-limited media because of the agency’s requirements on risk information. Cooke wrote that OPDP’s call for risk information that includes the most serious risks associated with the product, as well as all boxed warnings, makes it “difficult to imagine a product that has fatal or life-threatening risk, contraindications or boxed warnings that could be contained within the space-limited context of a Tweet, which has a 140-character limitation.” For example, he cited one product’s boxed warning, which alone contains 692 characters.

This approach “would limit the availability of space-limited communications to the small subset of prescription products whose risk and benefit information” meet the agency’s requirements, Cooke said, adding that the framework set forth by the draft guidance “seems more amenable to the participation of products with limited risks and short benefit statements.” He told the Coalition that the agency “could have suggested some approved abbreviations to help companies meet the requirements in a limited space – such as using ‘risks incl death’ instead of ‘risks include’ and listing all possible inclusions –but it chose not to.”

In an e-mail to Bloomberg BNA June 17, James N. Czaban, chairman of the FDA Practice Group at Wiley Rein LLP, said that the risk/benefit guidance “is actually very limited in scope” because it does not address many other types of online activity. He also told BNA that “The idea that FDA would allow a black box warning to be condensed for use in the format of Google Sitelinks or even Twitter is quite surprising given existing promotional limitations on black box products, and the length and seriousness of such warnings for many drugs,” Czaban told BNA. “Will any company risk such an approach from a liability perspective, even if it could meet the space limitations?”

Czaban said that “the bottom line is that FDA’s guidance leaves many questions unanswered, and its examples are of limited utility.”

Further, the FDA specifically states that this draft guidance does not apply to “reminder” promotions and reiterated that reminder ads cannot be used for drugs with black box warnings. “It is unfortunate that this guidance does not further clarify the Agency’s stance on such communications,” Cooke stated in the Regulatory Alert.

Cooke also pointed out that the FDA would like companies to use URLs that include both the product name and the word “risk” when they send message viewers to a company site for complete risk information, and discourages the use of URL shorteners. He noted that because many sharing platforms may automatically replace unshortened URLs with shortened versions, his company recommends that marketers develop URL redirects “that clearly indicate the destination while limiting character count to minimize the distortion provided by automatic shorteners.”

Correcting Third-party Misinformation Online

The second new social media draft guidance issued by the FDA is entitled “Internet/Social Media Platforms: Correcting Independent Third-party Misinformation About Prescription Drugs and Medical Devices.” This document provides recommendations to companies that choose to correct third-party information related to their own prescription drugs and medical devices (see CDER201240Guidance for the full draft guidance).

The agency provides key principles for correcting this information, which include a notation that doing so is completely voluntary. The FDA also states that although companies should keep records about the corrections they make, they are not required to submit the corrections to the FDA. Further, the draft guidance states that the company’s efforts to correct misinformation do not satisfy regulatory requirements.

In light of both of these draft guidance documents, Digitas Health LifeBrands recommends companies take the following actions:

(1)    Ensure that all messages (regardless of length) that require risk information include presentation of actual risks and not merely a link to risk information.

(2)    Review existing product Web sites to guarantee that they include a page dedicated to the presentation of risk information.

(3)    Establish self-evident, shareable URLs for pages dedicated to product risk information.

(4)    Review product indication and risk profiles to determine whether abbreviated versions of risk and indication information can be developed for use in space-limited contexts.

(5)    Review existing policies about correcting misinformation on third-party platforms to ensure compliance with the procedure set out in the new guidance.

(6)    Develop a plan and rationale for determining which sites/locations will be monitored for misinformation and what material will be corrected. (To read the full Digitas Health LifeBrands Regulatory Alert, go to: DHLB RegAlert Space-limited & Correcting Guidances DCooke.)

First Amendment Concerns

The Coalition’s Kamp remarked that despite assurances by senior FDA officials that they would address the serious First Amendment challenges raised by recent court decisions, these draft guidances contain no reference to the First Amendment and “no careful analysis of any of the proposed restrictions using the factors outlined in the Supreme Court’s Central Hudson test for commercial speech restrictions. These omissions could well come back to haunt the FDA if restrictions are challenged in court.”

Cooke added that it seems “the FDA believes that these promotional regulations are unaffected by the First Amendment decisions that have come down. They have not wavered from their message that where there is benefit information, there must also be risk information.”

Comments on the two draft guidance documents are due Sept. 16. The Coalition will be drafting a comment and welcomes member input. Please contact John Kamp if you are interested in contributing to the group’s comment.