New health care devices and medications make their way onto the market claiming to solve one problem or another. All of these are regulated by the U.S. Food and Drug Administration. However, officials will not fully know the extent of these products' uses or risks until they reach the population. Through its Sentinel Initiative, along with further research from future scientists, the FDA will have a thorough public health surveillance system to monitor citizens' and doctors' use of medical products.
Surveillance program regulating medical products
Signed into law in September 2007, the Food and Drug Administration Amendments Act required the FDA to create a system that would gather data from different sources to analyze for risk and assessment within the first two years. To fulfill its demands, the FDA established the Sentinel Initiative in 2008 to monitor the safety of medications and devices once they hit the market.
The administration's pilot project, Mini-Sentinel, combined pre-existing data from insurance companies, EHR software, research institutes and other health care information systems, to create a database from which information can be analyzed, the program's website explained. FDA officials can track products through the system and will immediately know any safety issues that arise with certain medications and technology. The data on FDA-regulated products can answer scientists' queries in a matter of weeks as opposed to the months it had previously taken.
"The FDA is pleased to see the pilot for the agency's Sentinel System, dubbed Mini-Sentinel, begin its transition to a full-fledged program," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a press release. "The Sentinel System will play an integral role in expanding the resources we have to track and understand important information about the drugs used by patients throughout the U.S."
While Sentinel can provide countless information about health IT and medications, it also comes with its potential issues. The lack of EHR interoperability can interfere with the FDA's goals just as it currently is with the Centers for Medicare and Medicaid Services' Meaningful Use program. For FDA officials to analyze the data, they need access to patients' information via their medical records.
FDA seeking researchers
In April, the FDA made a funding opportunity announcement, calling on all scientists and health care professionals who are part of the Reagan Udall Foundation to submit proposals for a research opportunity to further develop the methodology and work out issues of Sentinel. The federal grant would provide the recipient with $1 million to establish means for surveilling large databases made up of patient records and pharmaceutical information.
The FDA will choose an applicant from the RUF, as its Innovation in Medical Evidence Development and Surveillance program coincides with the FDA's goals toward improving the safety of public health. According to the funding announcement, IMEDS plan for fulfilling the FDA's needs includes research in the following areas:
- Bias in estimates from observational studies.
- The uses and limitations of the data.
- How previous IMEDS research can apply to FDA goals
- On-going risk and assessment
- Support for qualified investigators by providing access to EHRs and analytics
Proposals will be accepted until June 15 when the FDA will make its decision.
Contact Viztek for more information.
Ronny Bachrach
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