UCB to report AEs to FDA via website

Share this article:
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 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 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 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,” 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 meet the [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 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,” according to the release.
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Antidote: On Cystic Fibrosis treatments

Antidote: On Cystic Fibrosis treatments

Recent treatments in CF, including the inhaled antibiotic Tobramycin, have increased lifespan well into adulthood.

The $3 generic and the $1,000 pill: pharma outsiders just don't get it

The $3 generic and the $1,000 pill: pharma ...

What do you call the people who treat medical breakthroughs as if they were bank heists? Malicious? Uninformed? Not with it?

Leadership Exchange Uncut : The Agency-Client Relationship

Leadership Exchange Uncut : The Agency-Client Relationship

Click the above link to access MM&M's first Leadership Exchange Uncut e-book, "The Agency-Client Relationship"