FDA’s transparency task force proposes a multi-pronged approach to make the agency’s compliance and enforcement data more accessible and user-friendly online.

An Oct. 3 task force report includes eight draft proposals with steps to facilitate analysis of compliance and enforcement information.

Earlier in 2011, FDA unveiled an inspections database as part of its Phase II of the task force-led Transparency Initiative. Commissioner Margaret Hamburg created the panel in 2009 to improve online communication of information to the public and industry (Also see "FDA Unveils Plan To Boost Transparency To Industry" - Pink Sheet, 10 January, 2011.).

The latest proposals aim to allow the public to download and search the compliance information online, as directed by a January presidential memorandum to federal agencies.

Transparency “can drive good behavior and promote regulatory compliance,” FDA said.

Models From Other Agencies

In addition, the agency noted, the Environmental Protection Agency and Department of Labor have well-developed enforcement data websites and “have observed that making the data more user-friendly drives more users to the site.”

The task force’s proposals mirror features of EPA’s Enforcement & Compliance History Online and DOL’s Enforcement Data 2.0 websites.

In discussions with the agencies, the task force says, EPA reported ECHO to benefit a number of stakeholders, including companies, which can use it to monitor compliance across their facilities, and investors, who can factor compliance into their investment decisions.

DOL found its site reduces the number of Freedom of Information Act requests that draw resources away from other activities, the task force report states.

Improved Ability To Analyze Data

The task force presents most of the draft proposals in terms of actions FDA should explore to improve transparency in the compliance and enforcement realm and improve stakeholders’ ability to analyze the data.

FDA should integrate its compliance and enforcement data and its other publicly available data on regulated firms, and give its website the ability to conduct more advanced searches, such as product-specific or violation-specific searches, or predictive name searches, the panel says.

In addition to posting an analysis of the most common inspections violations, FDA currently posts compilations of its warning letters.

The task force suggests FDA consider whether expanding its analysis into other areas and posting the results would aid the agency’s own compliance efforts, as well as increase transparency.

The task force’s proposals mirror features of EPA’s Enforcement & Compliance History Online and DOL’s Enforcement Data 2.0 websites.

To improve data quality and timely data disclosure, the task force suggests FDA look at new technological tools, process improvements and administrative incentives, and determine how frequently data should be updated to be useful to stakeholders.

Other draft proposals include:

providing buttons on websites so stakeholders easily can report errors
establishing procedures to investigate such reports and correct errors expeditiously
use graphics and mobile web applications to draw users to compliance and enforcement websites and encourage data analysis
better use of social media, webinars and automatic email notifications.

In its one definitive proposal, the task force says FDA should provide an appropriate context for the data to prevent misinterpretation or misuse. That context can be:

information about the frequency of updating
reliability
average length of time between an inspection and posting of inspection classification information
definitions of inspection classification types
a statement that lack of information does not imply compliance or non-compliance by a particular facility.
- While the task force touts increased consumer access to more information that food and drug firms submit to FDA, industry stakeholders argue some proposals would not improve public health but would mislead consumers, give away trade secrets essential for innovation and compromise firms’ competitive position (Also see "More FDA Transparency May Confuse Consumers, Stifle Competition - Industry" - Pink Sheet, 2 August, 2010.).

Comments on the task force’s latest proposals may be submitted for 60 days.

After considering comments, the task force will recommend specific actions to Hamburg, who will decide by Jan. 31, 2012, whether to adopt any of them.

By Cathy Dombrowski

Compliance Data Should Be Linked To Enforcement Results – FDA Task Force

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