UCB to report AEs to FDA via community site

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UCB to report AEs to FDA via community site
UCB to report AEs to FDA via community site
UCB announced a partnership with PatientsLikeMe.com to launch an epilepsy-focused patient community, and will report adverse events to the FDA through round-the-clock surveillance. 

The Belgium and Smyrna, Georgia-based biopharma said in a release that the partnership will create “an online, open epilepsy community” in order to “collect, analyze and reflect information received from people with epilepsy, regardless of their diagnosis, prognosis or treatment regimen.” The online community is expected to launch in early 2010.

Ben Heywood, president and co-founder of PatientsLikeMe.com, describes the partnership as a win/win situation for patients and industry. “We're excited to work with a company that has such a depth of knowledge about epilepsy…and to provide an opportunity for UCB to better understand the effectiveness of epilepsy drugs across the board,” said Heywood. 

Members wishing to join the epilepsy community – or any other community on PatientsLikeMe.com – are not required to divulge any personal information, although many often do, according to Heywood. PatientsLikeMe.com is working with UCB to create a pharmacovigilance platform that will monitor the site for adverse events, utilizing “a unique patient identifier,” and is looking to hire a full-time pharmacovigilance manager, said Heywood. Adverse events will be reported directly to the FDA, he said, adding that PatientsLikeMe.com will not divulge personal or identifiable information to the FDA or UCB without the express permission of the patient. Only adverse events associated with UCB products will be reported to FDA, according to a UCB spokesperson.

“We're going to do what's best for the patient as well as what's necessary to the meet [FDA] requirements,” said Heywood. PatientsLikeMe.com does gather and sell patient information privately and to the FDA, but not identifiable patient information.

Patients joining the new community site will record their “real-time day-to-day progress in controlling their seizures and achieving their treatment goals, and share that with the community to help patients, caregivers, researchers and industry learn more about the disease,” according to the release.
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