Drug Safety and Shortages Challenge Manufacturers - As drug shortages make headlines, FDA tets the Sentinel safety system and its effect on healthcare - BioPharm International


Drug Safety and Shortages Challenge Manufacturers
As drug shortages make headlines, FDA tets the Sentinel safety system and its effect on healthcare

BioPharm International
Volume 24, Issue 3, pp. 12-17


As Sentinel moves forward, manufacturers and other parties are examining how to issue early drug-safety signals without leading to public misinformation or alarm. The pilot study on diabetes treatments and cardiac events, for example, raises questions about when and how FDA will make any findings public, noted GlaxoSmithKline general counsel Daniel Troy at the Sentinel workshop. Even if FDA says it won't release early results prior to full analysis, outside lawyers and policymakers may try to compel disclosure of such information.

CDER Associate Director for Medical Policy Rachel Behrman acknowledged that liability is on the agency's mind because it could drive companies away from the Sentinel project. Unrealistic expectations about what an active drug surveillance system can do raises liability concerns for pharmaceutical manufacturers as well as for data providers that could be accused of failing to warn the public about emerging safety issues, Troy added. FDA needs to make it clear to the public that Sentinel signals are based on observational data that often is not sufficient to make informed judgments about medical safety issues.


FDA is not the only government agency seeking access to health-plan data banks for secondary purposes, but its collaborative experience in establishing Sentinel may influence the shape of similar initiatives, Behrman suggested. It was not clear initially that Sentinel should be established as a public-private partnership, she said, but if "FDA had done it alone, in a silo, we would not be where we are today."

A new initiative for the US Department of Health and Human Services (HHS) is to build a multipayer claims database (MPCD) to support CER, as authorized and funded by the economic stimulus legislation of 2009. To meet this requirement, HHS Assistant Secretary for Policy and Evaluation Sherry Glied is establishing a centralized component that will hold de-identified claims and administrative data on some 100 million individuals in private health plans and Medicare. In addition, the project will build a distributed network component, similar to Sentinel.

Glied also is working with several states that have established their own MPCDs, primarily as cost-control strategies. About a dozen state initiatives from Maine to Utah are analyzing eligibility and claims data to track use and quality of healthcare services and products, while also looking for fraud, waste, and trends relevant to continuity of care and case management.

Ultimately, a national interoperable electronic medical-records system will feed patient-level information into all these data systems. With appropriate privacy protections, this arrangement will facilitate assessments of health care delivery and medical care for many purposes. The relatively early experience of FDA and its partners in establishing a system that can answer common drug-safety questions with rigor and credibility provides a "national resource for evidence development," said Mark McClellan, former FDA commissioner and current director of the Engelberg Center for Health Care Reform at the Brookings Institute. Demonstrating ways to link and analyze different data sources to develop evidence on medical product performance should be useful in drug development, comparative research, and assessing the quality of care delivered by healthcare organizations and providers, McClellan explained.

At the Sentinel workshop, Glied emphasized the need to coordinate the HHS MCPD project with Sentinel, and CDER Director Janet Woodcock similarly suggested that it's important to avoid "reinventing the wheel" with each initiative. Woodcock acknowledged that Sentinel is part of a broader effort to better use data to improve healthcare, and FDA, she said, "is willing to be a node" on these larger e-health information undertakings.

UnitedHealth Group Medical Affairs Chief Reed Tuckson echoed these remarks, pointing out that health plans are receiving hundreds of requests for data from federal, state, intrastate and demonstration projects, and that standards and efficient governance systems are needed for these projects to work. Tuckson agreed that these data initiatives can help improve healthcare and product safety, but "data is expensive," he said, and meeting all the requests costs a lot of money.

At a symposium sponsored by OMOP, Woodcock emphasized the importance of building a solid methodological foundation for interpreting results. The hypothesis is that one can identify characteristics in drugs that provide causal processes for adverse events, Woodcock observed. Better information on drug characteristics and health outcomes and a solid methodological foundation for interpreting results, she said, is critical for reimbursement purposes, for medical practice, and for regulatory decision-making.

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