Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance documents, which were originally promised by the FDA in 2010, represent the FDA’s latest attempt to provide direction for drug and device manufacturers concerning how and when they may use social media.
Drug and device labeling and promotion are highly regulated activities, subject to onerous approval requirements enforced by the FDA under the Federal Food, Drug, and Cosmetic Act (the “Act”). Under the Act, “labeling” includes “all labels and other written, printed, or graphic matter” that “accompany” a drug or device. 21 U.S.C. § 321(m); 21 C.F.R. § 1.3(a). This definition has been broadly interpreted by the courts to include materials that supplement or explain a drug or device, even when there is no physical attachment to the drug. See Kordel v. United States, 335 U.S. 345, 350 (1948).
Rapidly growing Internet-based technologies have made it quicker and easier for both manufacturers and independent third parties to disseminate information about drugs and devices. This has led to a host of issues including (1) what drug companies can say online about their drugs without violating the “misbranding” regulations; and (2) what drug companies can do with what third parties have said online about their drugs. The guidance documents attempt to answer both of these questions.
The Twitter Guidance: “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices”
The FDA’s position concerning manufacturers presenting “benefit information” for regulated drugs on electronic platforms with character space limitations is laid out in the Twitter Guidance. This Guidance instructs companies on the steps to take to avoid inadvertently “misbranding” a drug by providing information about a drug’s benefits without disclosing accompanying risks. With that in mind, the Twitter Guidance provides the following direction for drug companies seeking to use space-limited social media platforms:
- Include the brand and established name, dosage form, and ingredient information;
- Ensure that any benefit information provided is accurate;
- Accompany benefit information with risk information;
- Provide direct access to a more complete discussion of the risks associated with the drug or device. Notably, the Twitter Guidance says the link should lead to a page devoted “exclusively” to risk information; and
- If both benefit and risk information cannot be communicated within the space limit, consider using a different platform.
To prove that it is not impossible to provide the required information within Twitter’s 140 character limit (just very difficult), the Twitter Guidance provides the following – entirely fictional – example of an acceptable tweet:
Click here to view image.
Notably, this example from the FDA might not prove helpful in reality, especially considering that many drugs would be required to list more than one risk.
The main take-away from the Twitter Guidance is nothing new: to avoid enforcement, provide “truthful, accurate, non-misleading, and balanced product promotion.” If a company cannot achieve this delicate balance within Twitter’s space limitations, it should “reconsider using that platform for the intended promotional message.”
The Misinformation Guidance: “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices”
The Misinformation Guidance describes the “FDA’s current thinking” about how manufacturers and distributors “should respond, if they choose to respond, to misinformation” related to FDA-approved products, specifically when the misinformation is disseminated by third parties over the Internet. Per the Guidance, “misinformation” is “positive or negative incorrect representations or implications” about a company’s drug or device that is created by someone who “is not under the firm’s control or influence.” Thus, the Guidance does not apply when misinformation is created or disseminated by the firm itself.
Companies can, however, breathe a small sigh of relief; the Misinformation Guidance makes it clear that companies have no independent obligation to correct third-party posted misinformation. This may obviate the need for companies to continuously monitor and mine massive amounts of Internet data related to their products.
Nonetheless, the FDA recognizes that it may “benefit the public health” for companies to have the ability to correct misinformation about their products. With the public health benefit in mind, the Misinformation Guidance sets forth the following guidelines for companies that are seeking to voluntarily correct misinformation:
- Post the correction in the same area or forum where the misinformation is found. If that is not possible, reference the area where the misinformation can be found;
- Disclose that the person making the correction is a company employee;
- Include the package insert via PDF or link to the approved labeling;
- Limit the correction to the scope of the misinformation;
- Do not use the misinformation as a catalyst for promotional messaging; and
- Record misinformation corrections in case the FDA has questions or concerns.
The Misinformation Guidance’s bottom line is that “if a firm voluntarily corrects misinformation in a truthful and non-misleading manner,” then the “FDA does not intend to object if the corrective information . . . does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising[.]”
Although the draft guidance documents provide some clarification on the FDA’s positions, it is not clear that they provide a noticeable benefit to the industry. The strict requirements related to providing risk information, including linking to a page dedicated exclusively to risks, may sway companies away from using popular social media platforms at all. Indeed, the guidance documents may have the unintended consequence of limiting, as opposed to expanding, the information available to the public about a given drug.
Companies have 90 days from the publication to comment on the draft guidance documents.