FDA Partners With PatientsLikeMe For Post-Market Drug Reviews


PatientsLikeMe announces that it has signed a new research agreement with the FDA to help improve the government’s outdated post-market drug review process. Under the agreement, PatientsLikeMe will provide the FDA with access to thousands of patient-reported adverse events to help bolster its drug safety surveillance program.

Currently, the FDA relies on pre-market clinical trials to ensure that medications are safe and effective prior to public use. While clinical trials are helpful for confirming that new medications are effective, they do not ensure medications are safe for all potential patient populations. While clinical trials do screen for adverse events, they tend to be small in scope and do not assess how safe a medication is when taken by patients with multiple conditions or alongside other medications. “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,” says PatientsLikeMe Co-Founder and President Ben Heywood.

Once a new medication receives FDA clearance, the safeguards in place are even less effective at ensuring public safety and have resulted in several high-profile recalls over the years. Currently, the FDA performs periodic post-market assessments of drug performance. Those assessments are based largely on data submitted by mandatory manufacturer safety reports and the FDA’s Adverse Event Reporting System (FAERS). FAERS is a reporting system that relies on doctors and patients to voluntarily report adverse events encountered in practice. The problem with this process is that doctors and patients both tend to under report adverse events, leaving the FDA with very little data to guide its post-market drug surveillance programs.

Now, through its partnership with PatientsLikeMe, the FDA will have access to near real-time, patient-generated adverse events data. PatientsLikeMe launched in 2004 with the goal of building online support groups for people with chronic conditions. Today, the company has patient communities representing 2,500 conditions and each of those communities captures first-hand information on medication effectiveness and side effects. As a result, PatientsLikeMe has amassed a database of 110,000 patient-reported adverse events on 1,000 different medications. This information, and any future adverse events reports, will now be available to the FDA to guide its post-market surveillance programs along side its FAERS system.

PatientsLikeMe is doing well monetizing its growing drug dataset. In February, the company signed an agreement with Walgreens to provide the same patient-reported side effects information directly to consumers in Walgreen’s app and website.

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