Adverse events! Adverse events! Adverse events!
How many times have you heard that tiresome phrase from pharmaceutical companies as an excuse for NOT embracing social media marketing?
Practically every social media endeavor that drug companies have engaged in has been a traditional one-sided affair: the drug company talks to the visitor, the visitor never talks to the drug company.
Even in so-called online “communities” sponsored by drug companies, there is very little community at all. A case in point is the UCB-sponsored Crohn’s & Me website, which has been described as a “faux community” (see “Faux Social Marketing: Have Your Cake and Eat It Too!“).
Crohn’s & Me lacks the benefits of open-ended social networking.
The excuse, of course, is that onerous FDA adverse-event (AE) reporting requirements make it impossible for drug companies to sponsor or create truly open-ended social networking communities, even if they are not product related.
Social media advocates have long suggested that it is possible to handle any adverse events reported on pharma-sponsored sites, but no drug company was brave enough to be the first to try it — until now!
Biopharma company UCB and PatientsLikeMe, an online community for people with life-changing conditions, yesterday announced a strategic partnership to create an online, open epilepsy community that captures real-world experiences of people living with epilepsy in the U.S.
According to the press release, this “platform,” which is scheduled to launch in early 2010, is designed to collect, analyze and reflect information received from people with epilepsy, regardless of their diagnosis, prognosis or treatment regimen. That information specifically INCLUDES adverse events!
“PatientsLikeMe.com is working with UCB to create a pharmacovigilance platform that will monitor the site for adverse events,” says MM&M (here), “utilizing ‘a unique patient identifier,’ and is looking to hire a full-time pharmacovigilance manager… Adverse events will be reported directly to the FDA…Only adverse events associated with UCB products will be reported to FDA, according to a UCB spokesperson.”
Want to be a Pharmacovigilance Manager for an online community? Here are the responsibilities as posted by patientslikeme (see here):
- Implement, and eventually direct the company’s pharmacovigilance processes, ensuring that SOPs, policies, guidelines, and working practices are current and reflective of current process, procedures and regulatory/legal obligations.
- Learn and document the SOPs of our partner organizations and develop a portfolio of reporting levels for PatientsLikeMe
- Ensure audit readiness in collaboration with partners, to include:
- Support and assistance during regulatory/key customer inspections,
- Consultancy assistance with inspection observation responses, and
- Monitoring and follow-up closure of regulatory inspection/key customer corrective actions
- Implement and oversee the company’s records management program for safety data.
- Continue to upgrade our platform’s existing AE system to ensure reports are complete with minimal burden to our users.
- Plan and execute the expansion of the Pharmacovigilance group including policies, staff selection, and training.
All it takes is money and one FTE to get around the adverse event reporting boogey man! (See “Report from CBI’s eMarketing Forum: Taking on the AE Boogey Man“).
