For years the pharmaceutical industry has been imploring the FDA to provide guidance into how companies should – and should not – use social media outlets to share advertising and promotional materials. The amount of information that is required by the FDA for the advertising of clinical trial opportunities and new drugs is extensive. Traditional media vehicles, like television, radio and print have worked well with meeting these strenuous requirements. However, social media platforms are used by billions and currently pharmaceutical companies are hampered to access these potential consumers due to the strict FDA regulations. The consumers that were once able to be reached through traditional advertising are now turning off their TV sets and radio to log in to Facebook, Twitter and YouTube.
At 241 million active users, Twitter has nearly as many users as there are people in the United States. The challenge for pharmaceutical companies is how to compose a single tweet – within the 140-character limit – that could be approved by the strict requirements of the FDA. At stake is access to the billions of online consumers in the social media network.
Recently the FDA issued new guidance for pharmaceutical industry’s interactive marketing activities online. The new guidance does outline rules and expectations for pharmaceutical companies that are trying to promote and manage Twitter and Facebook accounts – also including blogs and blog comments, and disease-centric websites. Now companies aren't required to submit tweets, status updates, and Instagram shots before they're actually tweeted, posted or sent. Companies do have to submit all of the above for FDA review but only on a monthly basis and no screen shots of postings are required as long as links to the feed are provided.
One of the most significant impacts of the new FDA social media guidance is that pharmaceutical manufacturers might be allowed to turn on the comments feature of their websites without having to submit user comments for agency review. Previously, the FDA appeared leery of user comments and had indicated that the pharma company could be liable for all comments on their website, including user and company generated material. Now the FDA will not consider consumer-generated comments on a company owned website to be promotional or marketing content of the pharmaceutical company so reporting and reviews are not required.
The clinical trial industry is bound to still have questions regarding the FDA’s new guidance but hopefully by providing some clarity to previously unresolved issues, social-media fears will begin to ease and allow pharmaceutical companies to actively engage with the billions of potential patients who use social media on a daily basis.
Feedback from our clients has uncovered that some recruitment companies have been less than transparent about their use of social media for promoting certain clinical research studies. It didn’t take long for problems to arise, requiring the sponsor company to step in and shut down the activity. It was a smart and necessary move, as no one wants to jeopardize a study’s potential or a participant’s safety by acting outside of what is legal, allowable and ethical.
Confused about how the new social media guidance issued by the FDA will impact your social media platforms? Want to learn how to successfully advertise your clinical trial through the social media networks? The CSSi Online Patient Recruitment Media team has years of experience and a book of analytics to help carve out the right online strategy for your rescue or prospective program. Still feeling nervous? Give us a call or read more here: www.cssienroll.com/what-we-do/patient-recruitment/traditional-and-digital-media. Let us share with you our approach to successful internet global patient recruitment.