FDA head Andrew von Eschenbach has proposed a partial adoption of Institute of Medicine recommendations about drug safety. The Duke Clinical Research Institute and Mortara Instrument (a European electrocardiogram firm) have been tapped as assisting the FDA in its safety push.

The FDA’s CDER division, it seems, is getting an unidentified but new program or database to manage safety issues. “CDER is now implementing an electronic system to track postmarket drug safety issues,” the FDA said. “This system, which will replace multiple office- and division-specific systems, will enable CDER reviewers and managers to prioritize more effectively their work on safety issues and ensure that different organizational units have the same information.”

Another highlight: a March 2007 meeting to discuss a “Sentinel” network to proactively identify drug safety issues and combine private and public reservoirs of drug safety data.

Here’s what the FDA said:

“On March 7 and 8, 2007, FDA is sponsoring a public meeting to explore opportunities for linking private sector and public sector postmarketing safety monitoring systems to create a virtual integrated, interoperable Nationwide medical product safety network. Such a Sentinel Network could integrate existing and planned private and public sector databases to enable the collection, analysis, and dissemination of safety information about medical products to healthcare professionals and patients at point of care (i.e., in the clinic where this information is needed to make informed decisions about safe and effective treatments). FDA will engage the public and private sectors in a discussion of opportunities for public and private sector collaboration on activities that could develop the data collection and risk identification and analysis components of such a potential network.”

There’s also a new newsletter about drug safety in the works. Quoth the FDA: “We plan to regularly publish a newsletter on the FDA Web site containing summaries of the results, including methods, of FDA postmarketing drug reviews. The summaries will not include confidential, commercial or predecisional information. We believe it is important, particularly for healthcare professionals, for FDA to make readily available and easily accessible the results of our postmarketing reviews of adverse events. In addition, this regular newsletter will contain information on emerging safety issues, as well as provide information on recently approved products both to inform providers and to encourage reporting to the Agency.”

The announcement by the FDA is an ambitious, broad effort to reassure the public without explicitly committing the agency to now yet another attempt to deal with the perception that FDA did little, 30 months ago, when Merck withdrew Vioxx. The industry’s and the agency’s public opinion poll ratings have been falling ever since. The FDA’s ability to invest in new personnel or technology to monitor drug safety, of course, rests with the willingness of Congress to authorize such funds. Here’s how the FDA delicately summed up that reality: “In reviewing the IOM report, we find we are in substantial agreement with most of the IOM recommendations directed to the Agency. Driven by available science, we are fully committed to strengthening our drug safety program just as rapidly and efficiently as available resources allow.”

The FDA is striking a balance between saying “existing systems are satisfactory,” on the one hand, and “we have no idea why anyone is frustrated with us” on the other. But technology (from third parties and within the FDA) appears to be on the agency’s mind. Said the FDA: “Information technology is also creating new methods for risk communication. It has been well documented that a major source of drug safety problems is lack of timely, relevant safety information at the point of care—the bedside, the clinic, and the pharmacy. We are working with many partners to create new avenues for effective risk communication on drug safety and to develop technology solutions—for example, e-prescribing systems—to help minimize errors and promote the safe use of products. These solutions will also generate data that can be used to update postmarketing risk assessments.”

In some respects, it appears that discussions with its own programmers, consultants or third-party suppliers are advanced. Referring to an antiquated FDA system for managing reports of adverse events, the FDA said: “We are upgrading AERS II, the second release of the Adverse Events Reporting System database, a Web-accessible computer system, to add signal detection and tracking tools. These tools will allow safety reviewers to more efficiently and effectively identify and track safety signals from submitted adverse event reports.”

The New York Times beats all competitors to the story. That article shows that industry group PhRMA has approved the FDA proposals. To quote the NYT: “Alan Goldhammer, deputy vice president for regulatory affairs for the Pharmaceutical and Research Manufacturers of America, praised the F.D.A.’s announcement as a ‘very thoughtful and comprehensive response’ to the Institute of Medicine’s report.”