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FDA makes a deal with online patient group to study patient-reported drug safety data

The U.S. Food and Drug Administration (FDA) is teaming up with the largest online patient network to collect and study patient-reported drug safety data. The research agreement between PatientsLikeMe, an online network of more than 350,000 patient members, and the FDA was announced at the Drug Information Association’s annual meeting.

The two entities will work together to see if patient-reported data, starting with what’s in the PatientsLikeMe network — can be used to guide risk assessment and management regulations. The FDA’s current postmarket drug safety surveillance program only requires drug manufacturers to report adverse events. Reporting an adverse event is done voluntarily by healthcare providers and patients. By studying self-reported drug safety data to inform its decision-making, the FDA is giving patients and their providers a chance to be more involved in the governance of healthcare.

As part of the research agreement, the FDA will also consult the PatientsLikeMe archives, which hold 110,000 adverse event reports on 1,000 different medications. PatientsLikeMe has cooperated with other government agencies in the past, including: the U.S. Department of Health and Human Services, the Institute of Medicine, the Centers for Disease Control and Prevention and the National Institutes of Health.

In a blog post on PatientsLikeMe’s website, Sally Okun, vice president of advocacy, policy and patient safety, explained the company’s growth and what it hopes to accomplish by working with the FDA. Okun said PatientsLikeMe made a customized version of the FDA’s MedWatch safety information and adverse event program for its multiple sclerosis patients in 2008. The following year, the company released the first drug safety platform on social media. Okun said patients’ self-reported data will give the FDA an accurate picture of the effects of taking certain drugs. The FDA currently generates medication safety information from the results of clinical trials, which don’t always represent the patient population that will be taking the medication.

“Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world,” Ben Heywood, co-founder and president of PatientsLikeMe, said in a release.