An interview with Alice Tseng
Blakes hosted a special full-day program focused on the life sciences industry. Videos on a variety of topics discussed at the seminar are now available.
Many industries have jumped on the social media bandwagon, but pharmaceutical companies seem to be lagging behind.
Alice Tseng, a Partner in the Intellectual Property group at Blake, Cassels & Graydon LLP, attributes their hesitation mainly to a lack of control.
"I actually don't think it's a legal risk per se. I think it's more the risk of the unknown in terms of what patients might post about your product," she says. "There are going to be people who have tried a certain drug and are not happy with it, so if you're providing a forum for people to put their comments out there, you're at risk."
There are various regulatory risks associated with pharmaceutical companies using social media. Tseng, who is also a registered pharmacist, cites three key issues that companies should keep in mind: off-label promotion, balanced advertising and adverse drug reaction reporting.
In Canada, pharmaceutical companies are not permitted to advertise prescription drugs, therefore limiting what they can post online. A company can't advertise that a specific prescription drug is used for a certain medical condition, explains Tseng. "What it could advertise are things like Viagra — you say the name and Pfizer assumes that people know what Viagra is for," she says. "But if you've got a certain brand name that no one even knows what it's for — and it depends how you're using social media — there are limits on what you can advertise."
Pharmaceutical companies can only promote a drug in accordance with what it has been approved for by industry regulator Health Canada. Promoting it for a different indication is known as off-label promotion, which is not permitted. The Pharmaceutical Advertising Advisory Board's Code of Advertising Acceptance (PAAB Code) states that the manufacturer is responsible for the content that is provided, so if a patient indicates the drug was used for a different condition, the pharmaceutical company could still be held responsible. Tseng says the risk with social media websites like Facebook and Twitter is that pharmaceutical companies have very little control over what users will post.
However, she says companies can manage this risk by closely monitoring their social media accounts. "You can't just set something up and then think that you can go away. You've got to monitor it very carefully because anything can blow up very quickly," she says.
"Legally, companies can absolutely navigate it. It's just making sure that they're prepared for any unknown criticisms of their product and that they monitor their accounts carefully so they can take action quickly," she adds.
Tseng suggests companies establish clear terms and conditions regarding the type of content users can post, i.e., stipulate that they can't discuss specific drugs or disclose any personal information. In accordance with PAAB's Guidance Document for Online Activities, issued in January 2013, she also recommends restricting access to a target audience by requiring health-care professionals, for example, to register or if it's directed at patients, have them enter the drug's DIN number. This is also clearly outlined in the guidance: "When targeting messages to healthcare professionals and patients, appropriate measures should be taken to ensure that the content is not accessible by others. This is often referred to as 'gating' a site. A gate requires user authentication."
Another restriction, as stated in the PAAB Code, is that all advertising by pharmaceutical companies needs to be balanced. "When you're advertising things, it has to be balanced; you can't just say all positive things and nothing negative," says Tseng. "And sometimes there are limits, like if you're using Twitter there are space limitations."
Health Canada also requires pharmaceutical companies to report adverse drug reactions. "If manufacturers find out about adverse drug reaction reports about their products, under certain conditions they need to report that to Health Canada," says Tseng. "And so, I think companies are concerned that if they start sponsoring websites or doing things where people can just write whatever they want, they might be writing about adverse reactions and then they might have to report it to Health Canada."
Despite the risks, Tseng says pharmaceutical companies can benefit from using social media. For instance, they can use it to raise awareness about medical conditions and diseases, keep existing patients informed about the products they're using, encourage compliance and for marketing purposes. "The more you see something or hear something, the more familiar you are and you're going to remember it," she says.
In January 2014, the IMS Institute for Healthcare Informatics released a report called Engaging patients through social media, which stated: "In 2009, 70% of Canadians turned to the Internet for health-related information, and 92% of those used the search engine Google, rather than a health portal to gather this information."
Given this statistic, pharmaceutical companies may want to consider adopting a social media strategy. "Certainly if companies were more active in the space they might be more likely to get their message across instead of whatever is currently out there," says Tseng.
Following the IMS report, on June 17, 2014, the U.S. Food and Drug Administration issued a set of draft guidelines regarding social media: Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.
Although only applicable in the United States, Tseng says the guidelines may still be helpful for Canadian pharmaceutical companies to use as a reference. She says she doesn't expect Health Canada to issue specific social media guidelines any time soon.
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.