Inspection data to be opened up in FDA transparency plan

By Nick Taylor

- Last updated on GMT

Related tags: Proposal, Fda

The US FDA may add product and violation-specific searches to its publicly available database of inspections as part of a transparency push.

Enhancing search is one proposal to make data collected by the US Food and Drug Administration (FDA) more accessible to the public. Since 2009 a push towards greater transparency​ has driven FDA decisions and led to the publication of a list of all facility inspections​ conducted in recent years.

New proposals build on the release of the inspection database to increase public engagement with the information and in doing so boost transparency. In a statement the agency said: “[The FDA recognises] that transparency can drive good behaviour and promote regulatory compliance​.”

Adding product and violation-specific search options to make it easier to analyse the inspection data is one of eight proposals made by the FDA​. The other seven all work towards the goal of increasing access to enforcement and compliance data published by the FDA.

Cutting inspection review times is one aspect of the strategy. Better field technology and incentives, such as only giving inspectors credit when timelines are met, are proposed as methods to speed data disclosure.

The FDA also wants to improve how users view the data. Visualisations and mobile web applications are proposed to encourage users to engage with and analyse inspection data made available by the FDA.

Context is king

Making data accessible to the public increases the risk it will be misinterpreted and the FDA is alert to this issue. To minimise the risk the FDA is proposing to give context such as the average time-lapse between inspections and posting of information and how often the data is updated.

Before drafting the proposals the FDA met with the Environmental Protection Agency (EPA) and the Department of Labor (DOL) to discuss their transparency efforts. The EPA and DOL have led the US transparency push by creating websites​ to visualise and explore​ enforcement and compliance data.

Interested parties have until December 2 to comment on the draft proposals.

Related topics: Contract Manufacturing & Logistics, QA/QC

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