On 17 June 2014, the United States’ Food and Drug Administration (FDA) released two draft guidances relating to the promotion of prescription drugs or medical devices online or on social media. Designed with patients in mind, the FDA is aware that patients and health care providers often get information about FDA-regulated products through social media and other online sources, and wants to ensure that the information provided by manufacturers and their representatives is clear, accurate, truthful and not misleading.
In a blog published on the FDA’s website, Thomas Abrams, the director of the FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research has indicated that the guidances are the latest in a series, and were developed to respond to requests for best practices from companies and other stakeholders. When final, the two draft guidances will apply to manufacturers, packers and distributors (“firms”) of both medical devices for human use and prescription drugs for humans and animals.
The first draft guidance relates to balancing the disclosure of risks and benefits of drugs and devices when dealing with character space constraints (on Twitter and in Google ads). The FDA’s recommendations are quite onerous, particularly in relation to a firm’s obligation to include within each individual message, Tweet or Google ad:
- Prominent risk information: not just of fatal or life-threatening risks or contraindications (those required to be on the box of the product itself) but also of the most significant warnings or precautions about the product;
- a direct hyperlink to the product’s risk information website; and
- the generic drug name as well as the brand name (ie if a medicine with the brand name NoFocus has the generic drug name “rememberine hydrochloride”, then a Tweet which mentions NoFocus should include NoFocus (rememberine HCl)).
The second draft guidance is more controversial and relates to correcting independent third party misinformation (user-generated content or UGC), including on third party websites such as forums and social media sites. Importantly, the FDA does not require firms to correct UGC. This second guidance will apply only if a firm chooses to respond.
Is a firm responsible for user-generated content?
The FDA states that as a general rule, a firm will not be responsible for UGC, even if the UGC is on the firm’s own sites (ie the firm’s website or Facebook page) and the firm is monitoring for profanity/obscenity, particularly where the firm includes a clear statement that it is not responsible for UGC. However, a firm may be responsible for UGC depending on the level to which the firm has control over, involvement with, or influence over UGC (ie if the firm solicits or influences the UGC). [Note: This interpretation differs from some regulator and self-regulatory body guidance in Australia which has held that companies can be responsible for user-generated content on their social media sites when they become aware of it and choose not to remove or correct it].
What should the correction include?
If a firm decides voluntarily to correct misinformation, then the second guidance recommends that the firm’s correction be (amongst other things):
- relevant and responsive to the misinformation;
- limited and tailored to the misinformation; and
- non-promotional in nature, tone and presentation.
If a firm’s responses go beyond providing correcting information, then the responses may be considered advertising and other FDA guidances will apply.
A firm must define the portion of misinformation being corrected, but must take care that it does not only correct the negative misinformation within a forum, leaving the positive misinformation.
The guidance also suggests that firms keep records of any corrections they publish including the original information, date, and what they post in response.
The pros and cons of using practical examples
The guidances include useful practical examples which reflect the FDA’s current thinking in the space. Practical examples can be extremely effective, particularly for regulatory guidance in the social media space. The best example I have seen incorporating practical examples is the US Federal Trade Commission’s guidance on .com Disclosures (released March 2013). The FTC guidance includes screen shots, which are user-friendly and help to demonstrate the point in a visual way. The downside of using practical examples is that readers will automatically think of other examples which are not covered by the guidance, and there will always be some grey areas. The FDA has faced criticism on this basis, with some commentators suggesting that the grey areas left by these guidances may affect industry confidence to engage on social media.
It should be remembered that these guidances do not create or confer any rights or bind the FDA or the public. Given the complex legislative requirements of the US Federal Food, Drug and Cosmetic Act, it makes sense that the FDA’s guidance is onerous, and cannot possibly address every possible example or situation.
What about in Australia?
In Australia, the advertising of prescription medicines direct to consumers is prohibited by the Therapeutic Goods Act 1989 (Cth). The advertising of medical devices to consumers is permitted but must comply with the Therapeutic Goods Advertising Code, which contains some specifics around the requirements for online advertising, but nothing directly addressing character limitations or user-generated content.
While the application of the FDA’s guidances is limited to medicines and medical devices in the US, it is interesting to consider yet another regulatory body’s current views on promotion via social media, and to see the way the FDA has chosen to navigate the many grey areas of this space.
The FDA is accepting comments on both draft guidance documents, via the Federal Register until 16 September 2014.