Copyright 2011, Blake, Cassels & Graydon LLP
Originally published in Blakes Bulletin on Intellectual Property – Social Media Series, January 2011
The use of social media to advertise regulated products, such as pharmaceuticals and medical devices, can be very powerful, but is also fraught with risk. Recently, a drug company entered into a clever but provocative partnership in the United States with a professional race car driver, who also happens to be an avid TWITTER user and diabetic. In response to the driver's request to TWEET about two insulin products made by the company, the company said he could only do so if he included the drug's generic name as well as a link to information about the drug's risks and benefits. The driver now regularly TWEETS about his insulin, a recent example being, "Saw an ad for [branded product] on TV! For [branded product] [generic name] prescribing information: [website link]".
By contrast, some companies have not fared so well with their foray into social media. Another major pharmaceutical company in the U.S. set up a FACEBOOK page that was soon flooded with postings by one disgruntled patient who claimed that the company's chemotherapy drug disfigured her because it caused permanent baldness. The patient said that she took her dispute to FACEBOOK because she had written multiple times to the company to no avail.
The company subsequently posted a disclaimer on its FACEBOOK page stating that the page is not intended as a forum for discussing products of the company or other companies and that postings containing any product discussions would be removed. Although the offending posts were removed, the public relations damage was already done.
Although social media are already crucial advertising vehicles for many companies, it has not been as widely embraced by those in the pharmaceutical and medical device industries. One reason for this is the lack of clarity on how health regulators will view certain activities. Although laws of general application apply regardless of the advertising medium used, the application of these general laws can be uncertain.
Compared to traditional media, social media are more interactive, with businesses having less control. Businesses contemplating initiatives using social media are concerned about their potential obligations and liabilities relating to the content and action of an unrelated third party.
Guidance by Regulators on Social Media Advertising
The lack of certainty on how laws are applied has many stakeholders anxiously awaiting the U.S. Food and Drug Administration's (FDA) guidance on advertising in social media. The FDA held a hearing on the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools" in late 2009. Interestingly, some submissions essentially stated that the key is that guidance be issued, whatever the guidance may be.
Although the FDA had been expected to release guidance by the end of 2010 on a comprehensive range of issues, it now appears that the FDA's new target is to release guidance on one issue by the first quarter of 2011.
Despite the FDA's delay, Canadian guidance specifically addressing advertising in social media will likely lag the U.S. since, although "[t]he idea of creating guidelines for the pharmaceutical industry's social media marketing projects was raised" at the April 2009 meeting between Health Canada and Canadian advertising pre-clearance agencies, no significant advance appears to have occurred.
It is interesting to note that a number of Health Canada's general advertising policies now make reference to "social media", if only to reinforce the principle that Health Canada's general advertising requirements apply regardless of the medium.
Advertising Drugs an d De vices in Social Media
The following highlights three key issues that advertisers of pharmaceuticals and medical devices should consider prior to embarking in the realm of social media, namely: (i) off-label claims; (ii) insufficient disclosure; and (iii) reporting obligations.
Given the lack of guidance from the regulators, there are many unanswered questions and how these issues will be resolved is unclear. However, set out below are some questions and factors that companies should at least consider so they can make a more informed assessment of their risks and determine the best approach in the absence of official guidance.
1. Off-Label Claims
Pharmaceutical and device companies cannot promote their products "off-label" (i.e., they cannot promote their products for an unapproved medical condition or use). Although this is clear, what is less clear is a company's obligation or responsibility when an off-label claim is made by a third party.
For example, a company might sponsor an initiative where patients, consumers or health-care professionals can post comments or questions about a particular drug or medical device. What happens if a third party makes an off-label claim about the product?
Does the company have any obligation to post a disclaimer stating that the product is not approved for the off-label condition or, alternatively, stating the approved condition, or both? Or, should the company delete the off-label claim altogether?
Alternatively, should the company have instead screened all submissions in the first place to ensure no off-label claim is ever posted? Further, should the rules vary depending on whether the forum for postings is for patients, consumers, or health-care professionals?
2. Insufficient Disclosure
Advertising of health products typically requires the disclosure of certain information. Certain drug advertising, for example, requires the disclosure of "fair and balanced information about the benefits and the risks".
However, with certain social media formats, space limitation is a major issue. For example, TWITTER limits TWEETS to 140 characters. Does a requirement to disclose the risks of a product mean that the actual risks must be spelled out or would a link to a website spelling out those risks be sufficient?
The FDA has taken some action which is instructive. It recently issued a notice of violation letter to a major pharmaceutical company regarding its use of the Facebook Share widget on the company's leukemia drug website. When a user clicked on the Facebook Share widget, a brief description of the drug and a link to the website for the drug was sent to the user's Facebook page for sharing with other Facebook users.
Although the website contained risk information for the drug, the FDA letter stated, "the inclusion of such a hyperlink is insufficient to mitigate the misleading omission of risk information from these promotional materials. For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug."
3. Reporting Obligations
Although all companies bear the public relations risks that a discussion of their products or services in a public forum may generate negative comments, manufacturers of health products bear additional statutory reporting obligations if side effects of the product are discussed.
For example, in Canada, manufacturers of drugs must report any "serious adverse drug reaction" occurring in Canada, and any "serious unexpected adverse drug reaction" occurring outside Canada, within 15 days of receiving the information.
Health Canada guidelines specifically state that drug manufacturers "should regularly screen websites under their management or responsibility for potential adverse reaction case reports". Further, the guidelines state that the test for whether a case is "reportable" is the same for cases from the Internet as for cases obtained via other means.
Therefore, as long as the following minimum criteria are met, a company must report the case to Health Canada:
- an identifiable reporter (source);
- an identifiable patient;
- a suspect product; and
- an adverse reaction.
Although the rules may seem clear, it can sometimes be difficult to determine whether a case should be reported. For example, over the Internet, it is often unclear in which jurisdiction a patient is resident, and yet whether a reaction is reportable to Health Canada can be dependent on whether it occurred in Canada or elsewhere.
Further, the Health Canada guidelines state that "One or more of the following should automatically qualify a patient as identifiable: age or age category (e.g., adolescent, adult, elderly), gender, patient identification number, or reference to a 'patient'.
Given the broad parameters that qualify a patient as identifiable, a manufacturer may unintentionally make duplicate reports because it may be uncertain whether the same case is being discussed multiple times or whether multiple cases are being discussed.
Moving Forward with Caution
The three issues mentioned above highlight only a few of the concerns raised when drugs or medical devices are advertised using social media. Drug and device companies must take particular care to thoroughly assess any proposal involving social media and to consider how the proposal can best be structured to minimize any potential risk.
As part of the assessment, companies should remember that they will also need to be diligent in monitoring what transpires after the initiative is launched so they can respond immediately if required. If the social media initiative is structured appropriately, just as with the use of the drugs and devices themselves, the benefits can certainly outweigh the risks.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.