Social media has gained importance as a means of communication over the past several years.
Sites such as Linked-in, Twitter, and Facebook have provided means for professionals and corporations to disseminate information faster than ever before.
However, professionals in the pharmaceutical industry have been reluctant to use these outlets as a means of promoting products because of the Food and Drug Administration’s regulations regarding promotional materials. As such, the Food and Drug Administration has been taking steps to address these issues.
Since the Food and Drug Administration’s first public hearing regarding the use of social media in 2009, the agency has issued four guidances on the subject. The first guidance issued was issued in 2011, and the other three were issued in 2014.
The first guidance addresses issues regarding responding to requests for off-label use of prescription drugs and medical devices.
These unsolicited requests include public requests, such as those received in e-mails to a group, asked during live presentations, and posted on a website or another online forum, or nonpublic requests, such as those solicited via e-mail or phone call.
According to the guidance, manufacturers can answer both public and nonpublic requests; however, they must follow several parameters. In both cases, they must provide accurate, truthful, and balanced information regarding a product’s off-label use.
The information must be based on scientific data, be nonpromotional in nature, and should only answer a specific request.
If the request is private, manufacturers provide the information only to the individual making the request. The information should be distributed by medical personnel who are not a part of the marketing department. These personnel should also make certain that they have obtained all relevant background data before they provide the response.
The second guidance discusses the fulfillment of regulatory requirements for postmarketing submissions of interactive social media for drugs and biologics.
In this guidance, the Food and Drug Administration seeks to clarify its thinking about the use of social media to promote drugs.
Under the Federal Drug and Cosmetic Act, the Food and Drug Administration is tasked with regulating promotional materials, and social media is not exempt. As such, manufacturers would first be required to submit these materials to the Food and Drug Administration as part of their postmarketing surveillance.
This includes blogs and other materials that a manufacturer develops and those to delegated to third parties.
The third guidance discusses how to correct misinformation distributed by third parties via social media. It describes how a firm would approach correcting inaccurate product statements made by a third party.
According to the guidance, the information should be factual, relevant to the statements made, and nonpromotional.
The fourth guidance discusses how to convey risk-benefit information via social media that has character limitations.
Per the guidance, risk-benefit information should be balanced with respect to promotion of products. Although this can be challenging given the space limitations of some social media outlets, both benefits and risks should be communicated within the appropriate constraints.
The use of social media to promote pharmaceutical products poses some unique issues because of the Food and Drug Administration’s regulations.
By issuing several guidances, Food and Drug Administration’s policy is becoming clearer and will enable pharmaceutical corporations to use social media as a viable means of promotion as technology advances.
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