FDA Moving Forward with Postmarket Safety Network

NEWS TRENDS

FDA's postmarket product safety network got jump-started during a two-day public meeting held in March to get feedback and suggestions from industry. Called the Sentinel Network, the integrated, nationwide electronic system would focus on data collection, risk identification and analysis, and risk communication.

Although FDA continues to evaluate comments and what it learned from that public meeting, it has begun the process of developing a white paper that provides a road map of the network. Jeff Shuren, MD, JD, assistant commissioner at FDA's Office of Policy, provided an update about the Sentinel Network at a risk management conference in May. He said that industry can expect the white paper in the “very near future.”

Establishing the postmarket surveillance network will be feasible if the agency is able to take advantage of current programs in both the public and private sectors.

Priorities of the network include rapidly identifying suspected risks as well as providing more information about known risks. Healthcare practitioners need up-to-date information about risk-benefit profiles. Part of the problem is that risk management strategies at the premarket phase are based on the best available information, which is often incomplete. “Current efforts tend to be crisis driven,” said Shuren.

Shuren noted a few areas on which the agency needs to focus when designing the network. Considering the volume and sensitivity of the information exchanged, the network will need to be able to protect patient privacy and data security while transferring data in real time. It's possible that electronic health records would fit into this scheme.

He also suggested integrating a component involving safety biomarkers and pharmacogenomics. From a risk management position, this could help gather more information about patients before harm develops and help find better ways to identify which patients are prone to experiencing certain risks.

From a practical standpoint, the agency needs to look at what infrastructure it should use for the network, what kind of financing it will need for developing data-mining software, and how it can provide incentives to provoke industry participation.

Shuren strongly encouraged industry to give FDA feedback and suggestions about how to design the network. He also urged firms to support and advocate the network by getting involved in public collaboration.

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