Guest Column | March 16, 2015

The Use Of Space Limited Social Media To Distribute Risk Information

By Darshan Kulkarni, Pharm.D, MS, Esq. and Kimberly Koon, Pharm.D


Social media can improve non-promotional safety communication in the life science industry as it allows for the quick communication and dissemination of safety information, eliminating the time and money it takes to publish and distribute on paper. While there is a lack of specific guidance on sharing risk communications via social media, it may be possible to enhance the safety of biopharmaceuticals by using timely and measurable social media communications without violating FDA guidelines or regulations.


“Dear Healthcare Provider Letters” and Medication Guides
Products with significant risk considerations are often approved by the FDA subject to risk management programs called Risk Evaluation and Mitigation Strategies (REMS). While there are a range of REMS programs that a product may be required to adhere to, most REMS require ongoing communication with providers and may also involve consumers. Such on-going communications include letters to healthcare practitioners, traditionally referred to as “Dear Healthcare Provider Letters” (DHCPL). These letters are traditionally mailed to healthcare providers who may work with the product. DHCPLs may also be used outside of a REMS program to update practitioners on new safety-related product information.

Additionally, medication guides with safety information that is part of a REMS program may also be provided to HCPs for distribution to patients. Patients are to receive a medication guide when receiving the medicine in accordance with FDA REMS requirements.

Using Social Media
The FDA previously stated that it “[encourages] the use of innovative technologies to disseminate safety information, particularly when doing so can provide a public health benefit.” While the quoted guidance primarily targeted email communications, social media messages and web pages would satisfy many of the expectations. Provided the information is strictly safety related and non-promotional/contains no links to promotional material, social media could be acceptable means of communicating product risk information to the public.

Creating Social Media Messages 

Headings and Social Media
In the DHCPL FDA guidance the FDA opined on the appropriate use of email subject headings for safety communications with healthcare providers. Despite space limitations, the FDA says email subject headings must include the brand and generic names of the drug, include a short description of the issue, and address the seriousness of the matter. The space limitations associated with an email subject heading are similar to the space limitations associated with certain popular space-limited social media platforms such as Twitter (collectively “SLSM”) and, therefore, may be instructive on how to phrase social media communication.

Paper Mailing Headers
Guidances and regulations related to risk communications for paper mailings suggest statements to include on envelopes containing DHCPLs. However, these principles for paper mailings may also apply to SLSM. The FDA found the following examples to meet its requirements for paper risk communications:

  • “Threefold Increase in Risk of Macular Edema in Elderly Taking DRUG NAME” 1 Characters=71
  • “Severe, Life-Threatening, and Fatal Cases of Hepatoxicity Reported with DRUG NAME” 1 Characters=82
  • “Important Correction of Drug Information” 2 Characters = 40 

It is interesting to note that each of the statements above also meet SLSM limits while leaving sufficient space for a short link.

Once a message has been drafted, communication of the message must meet several FDA requirements. In particular, these messages must meet the needs of each audience. Therefore, communications directed to patients and healthcare providers must be communicated differently to ensure that each audience appropriately understands the gravity of the safety concerns.

However, due to the easy and widespread access to social media, every message sent via social media would typically be directed to the general public. Specific guidance on how to narrow the audience when using social media is unfortunately unavailable. However, since information directed to healthcare practitioners may not be easily understood by non-healthcare providers, a compromise may be achieved by addressing the general public but restricting access to technical information using authentication pathways, such as passwords. Also, this method could be used to collect user generated data for evaluating REMS programs. 

For example, a REMS communication plan communicated via social media could contain a link to a medication guide intended for lay audiences. However, the medication guide page could then redirect healthcare providers, via links and security steps, to additional information. 

Limitations of this Methodology
It is important to note that specific FDA guidance on the use of social media to share risk communications is unavailable. Accordingly, this article applies existing FDA guidance to the process of distributing DHCPLs without violating FDA recommendations. There is currently no indication that the FDA will deem these processes sufficient. However, considering that FDA has an interest in allowing for quick, adequate, and appropriate distribution of risk information, and since the regulations, guidances, and laws have not indicated that these methods would be unacceptable, the methods proposed in this paper seem like a sufficient compromise.

Safety communications from life science companies can take advantage of the speed, visibility, and measurable impact of social media to improve public safety. Using rapid distribution technologies like social media, companies can communicate safety information quickly and accurately with healthcare providers and consumers and remain in compliance with the various preexisting FDA guidances. Accordingly, the use of such technologies may be appropriate in the future in the context of distributing risk information.