By Ann Neuer

November 3, 2009 | When it comes to consumer safety, the Food and Drug Administration (FDA) is upping its game in a big way.  Fueled by two key pieces of legislation—the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the Prescription Drug Use Fee Act IV (PDUFA IV)—the Agency has launched a number of initiatives aimed at detecting safety signals sooner in pharmaceuticals, biologics, and medical devices.  Much of the detection work will happen through the use of huge databases that will be queried for specific questions related to the frequency and severity of adverse events in various populations and therapeutic areas.

Barton Cobert

Barton Cobert, Pharmacovigilance Strategy and Client Services Advisor for APCER Pharma Solutions, a drug safety provider, says that the initiatives are in early phases and some will foster public-private partnerships.  “IMPACT, for example, which was developed to fulfill a PDUFA commitment, is intended to evaluate the effect of our spontaneous adverse event reporting system on patient safety.  FDA solicited proposals from companies interested in and capable of evaluating the system and making recommendations to the Agency,” Cobert explains.

On October 27, PPD, a contract research organization (CRO) announced that it had received a $2.7 million award for year one of IMPACT’s two year project.  Under the contract, PPD is to perform the evaluation and prepare a detailed report for FDA, which it will use to develop an implementation strategy to optimize use of the surveillance system as part of its pharmacovigilance efforts to protect public health.
 
The Sentinel Initiative, which grew out of the FDAAA legislation, is a vast project launched by FDA in May 2008.  It, too, uses a public-private partnership format.  Its focus is on the development and implementation of the “Sentinel System” that will complement existing adverse event reporting systems within FDA.  The Sentinel System will operate proactively and will enable FDA to query a wide array of databases such as electronic health record systems, administrative and insurance claims databases, and registries to collect information about regulated medical products.  The owners of the data will maintain and manage their own databases and they will be invited to participate in queries.

So far, various projects have been completed to define how the infrastructure and governance of the Sentinel Initiative will take shape.  The projects have researched the evaluation of database models to be used, strategies for engaging consumers in participation in the Sentinel Initiative, and evaluating potential sources for data on blood and tissue product safety surveillance. 

To develop the queries and manage solicitation of participants, FDA is expanding its staff.  “FDA has been on a hiring binge.  They’ve hired hundreds of people, who hopefully, will help the Agency target and prioritize the queries.  At this point, we don’t know if the burden of analysis will be on the companies, on FDA, or if there will be joint ventures,” says Cobert. 

OMOP, a contributor to the Sentinel Initiative, will also use databases to glean safety information.  OMOP is funded by the Foundation for the National Institutes of Health (NIH), and has as its primary goal assessing the use of observational data to identify and evaluate the association between health-related conditions and prescription drugs.  This initiative is a public-private partnership, and it is currently undertaking a two-year study to research methods that are useful for analyzing existing health care databases.  A host of government, academic, and industry stakeholders are involved in OMOP, such as NIH, FDA, Indiana University, Computer Sciences Corp., Prosanos, Merck, and others. 

To facilitate its research, OMOP has developed the Common Data Model, a common structure and framework for organizing and standardizing observational data.  “By late next year, FDA will hopefully have the ability to start accessing large US databases to run queries, look for signals, validate known signals, and examine risk,” Cobert comments.