By: Jeff S. Gibson, Attorney
The FDA announced an agreement with PatientsLikeMe, an online database where patients share healthcare information and experiences, to analyze data and provide new insights into drug safety. This agreement was created with the intent to provide better post-market surveillance of drugs and medical devices and increase patient safety outcomes. The FDA plans to analyze self-reported, real-world data stored in the database of more than 350,000 members with more than 2,500 conditions according to PatientsLikeMe.
Increasing patient drug safety through information gathering
The FDA and PatientsLikeMe will now work together to create a stronger post-market drug safety database. Prior to this agreement, the FDA relied solely on its adverse event reporting system which requires drug manufacturers to report patient injuries and deaths but allows healthcare providers and patients to participate on a voluntary basis. This agreement now gives the FDA access to a database of approximately 350,000 PatientsLikeMe members who are living with more than 2,500 medical conditions. PatientsLikeMe has reported that it has collected more than 110,000 adverse event reports on 1,000 different medications since it was created in 2008. This data will now be available to the FDA through this agreement.
Why post-market drug surveillance is important
Although drug makers conduct testing during the research and development phase through clinical trials, vigilance is still necessary after the drug is approved for use. Post-market drug surveillance helps to identify trends by examining patient outcomes such as side effects and injuries. The FDA has stated that in some cases where there is a concern about risk or if there is not enough information to determine how to address a risk in labeling, post-market studies or clinical trials to gather additional information may be required.
Serious injuries and defective drug lawsuits
While drug manufacturers create pharmaceuticals to improve the quality of life for people who suffer from illness and disease, the same pharmaceuticals can also cause great harm and have a permanent negative effect on a patient if the proper safeguards are not in place. When a drug maker fails to report all data gathered from a clinical trial or does not take action when a negative trend occurs in patients, patients safety is at risk.
I am a product liability attorney who has worked on numerous cases involving dangerous drugs and medical devices. My firm has represented thousands of people who have been harmed when drug and device makers have put profits ahead of people. If you have suffered a serious injury as a result of a recalled medicine or device, you may have a legal claim and could be compensated for your damages. For more information about the types of cases Cohen & Malad has handled or to discuss your potential case, contact me.