The following is an article that was originally posted on PharmaIQ.
The author is Cristina Falcão.
The world’s most highly regulated industry seems doomed to “forward retreat” tiptoeing into social media. Why? The reason lies on social media’s gist – user generated content (UGC) is the raison d’être but also the main drawback, since the lack of rules on the accuracy of online content (written by the users of websites such as Facebook, Twitter and LinkedIn) makes pharma accountable.
Effective guidance, equally issued by the EU and US drug agencies, is urgently needed, before pharma companies can use social media’s valuable contribution in areas such as pharma-vigilance, clinical trials, R&D, and employee- recruitment.
What is the current guidance situation?
Unlike in the US, the European Directive 2001/83 (Community Code) forbids public advertising of “prescription-only medicines”. On the other hand, EU offers little specific guidance on social media (apart from some EFPIA -guidelines on websites, and the PMCPA’s (UK) “Brief guideline on blogs”), and waits for the US approach; however, FDA rules on pharma, internet and social media, which draft was due at the end of 2010, still have not been issued.
Pharma companies are responsible for the contents of a sponsored website (sponsorship can simply be advertising); yet, it is virtually impossible for the industry to control a website’s UGC without undermining the dynamic nature of social media. Adverse events reporting (AER) is a nightmare: the law states pharma companies must report all those events to the respective regulatory agencies, where they are stored in databases to monitor drug safety. It is impossible for the industry to monitor all AER’s, and marketers fear that user-generated content will include complaints about their drugs’ side effects; what makes it even worse, is the fact that FDA’s databases are regularly searched by lawyers for potential class-action suits.
Nevertheless, there are many pharma companies using Facebook, Twitter, YouTube and other social media tools; the only way out, is to monitor activity on any social media platform where they are present, using disclaimers, reserving the right to remove unwanted comments and redirecting drug questions to the company’s website.
Patient-recruiting for clinical trials through social media, grants decreased R&D costs to the industry. However, clinical trials have several types, designs, and sample groups; social media, alone, is not the universal source. It can prove to be a double-edge sword, if patients interact and exchange information before the whole trial is completed; also it does not ensure evaluable data in the end. Patient- recruiting outside the physician’s own pool of patients has high dropout rates; tweeting about a clinical trial may build awareness of the opportunity, but does not guarantee an engaged PI, who will lead the patient through the clinical trial, thus assuring collection of meaningful data.
Although ‘social media’ is the overhyped buzzword of our time, for pharmaceuticals it will be a treacherous route: regulations will undoubtedly limit (further) interaction with the public, but increase accountability – it not being worth the effort or risk.
All we know for sure is that the debate has only started.