Beginning in March 2011, companies testing experimental drugs or medical products will be required to inform the FDA within 15 days about serious risks and adverse reactions that arise during clinical studies (FDA, Sept. 2010). This isn’t anything new … the FDA just wants to make it simpler. The final rule is a revision of a proposed rule that was issued in March 2003. Apparently, many companies were piling information on the FDA in droves, making it harder for the agency to sift through the data quagmire to find the necessary information. Wanna make it easier on yourself and the FDA? Think Electronic Regulatory Reporting.
The new rule, released at the end of September 2010, requires companies sponsoring new drugs or medical products to report any safety issues within 15 days after they become aware of them. This includes suspect adverse reactions and any findings “that suggest a significant risk to study participants.” It also clarifies when to report harmful side effects — after the first time or after more than one occurrence has taken place.
Prior to this final ruling, safety reports about clinical trials were submitted to the FDA by the droves, usually including too much unnecessary information. While it may seem that more information is better, in this circumstance, it actually was worse. The FDA had difficulty reviewing and evaluating the mounds of paper, draining their resources. The new rule hopes to increase the amount of truly useful data, simplifying the process and also aligning it with international regulatory organizations.
So how can drug companies and medical device companies make it better for themselves, the FDA and end user safety? The FDA’s CDRH center introduced an electronic Medical Device Reporting (eMDR) system in 2007 to help identify patterns in adverse events more easily and reduce the overwhelming number of paper reports. With over 300,000 reports submitted annually, of which all historically have been entered manually into their Adverse Event databases, the FDA is encouraging electronic regulatory reporting.
The FDA wants to use electronic reporting so it can:
- Easily identify patterns in adverse events for patient safety, where they can capture all the appropriate codes and trend on all data elements from initial reporting through follow-up.
- Reduce the non-value added costs and eliminate manual data entry of these reports, so it can drive consistency and quality of data entered into the system.
- Receive accurate and timely information to quickly make decisions and communicate more effectively not only within the organization but to other countries as well.
The benefits are many, including:
- Cost Savings. By moving to an electronic submission, you eliminate the need to print paper reports and the cost to ship them (overnight, in many cases) to the FDA.
- Easier Tracking. Electronic submissions allow companies to electronically track their pass/fail submissions. This can reduce FDA fines by allowing companies to respond faster and also reduces the number of “lost” packages causing unnecessary fines. In addition the manpower to track the “return receipts” and then file or scan them into your complaint file is eliminated.
- Timeliness and Accuracy Improvements. Once data is in the standardized format, the report can be sent, verified and confirmed quicker than with paper submissions. This will help reduce FDA’s requests for specific information that may have been overlooked within the report.
Once you get started submitting electronically, you’ll wonder how you ever got anything done the “old paper way”!