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US Congress Committee Issues Report On “Highly Invasive” FDA Surveillance Of Employees

26/02/2014 by Intellectual Property Watch Leave a Comment

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The United States House of Representatives Committee on Oversight and Government Reform today released a report detailing the US Food and Drug Administration’s “highly-invasive” surveillance programme that monitored employees who contacted Congress and the media, according to a press release from the committee leaders. Surveillance was unauthorised and whistleblowers were not given sufficient protection, the report found.

Below is the press release:

 

Report on FDA Employee Monitoring: Agency Still Lacks Adequate Whistleblower Protections

WASHINGTON – Today, House Oversight and Government Reform Committee Chairman Darrell Issa, R-Calif., and Senate Judiciary Committee Ranking Member Chuck Grassley, R-Iowa, released a joint report on the U.S. Food and Drug Administration (FDA)’s highly-invasive surveillance program that monitored employees who contacted Congress and the media with concerns about FDA’s medical device approval process.

Grassley’s testimony before the Oversight Committee on the report is available here.

In April 2010, the FDA initiated a surveillance program of unprecedented scope to monitor employees in the Center for Devices and Radiological Health.  The program allowed FDA managers to read communications between FDA employees and Congress, the U.S. Office of Special Counsel (OSC), and their personal attorneys.  The Joint Committee report, entitled “Limitless Surveillance at the FDA: Protecting the Rights of Federal Whistleblowers,” found the FDA acted without regard for employees’ whistleblower rights, which protect their communications to Congress and OSC.  The joint report also found that FDA conducted the program without adequate guidelines in place and made no effort to limit the scope of the program to exclude protected communications.

The Oversight Committee will hold a hearing on the FDA’s surveillance today at 10:00 a.m. in 2154 Rayburn House Office Building.

Key Findings:

•   Insufficient authorization and guidelines. The monitoring was implemented with insufficient written authorization, no policy in place and no legal guidance given to the contractors conducting the monitoring. As a result, FDA captured communications that are protected by law, including communications with Congress, the media, and watchdog groups like Project on Government Oversight.

•    Unlawful capturing of protected communications. Because no formal monitoring policy was in place, FDA managers did not understand the legal limits of employee monitoring. The FDA’s surveillance was not lawful, to the extent that it monitored communications with Congress and the Office of Special Counsel. Federal law protects disclosures to OSC and Congress.

•    Lack of explanation for capture of future communications. Instead of looking back at previous communications using available tools, the FDA captured real-time communications of current and future communications. When interviewed, FDA managers and IT professionals failed to explain clearly how the rationale offered to justify the monitoring (investigating a past leak) was consistent with the method used (monitoring current activity).

•    New policies do not offer sufficient whistleblower protections. In September 2013, the FDA issued interim policies that require written authorization prior to initiating employee monitoring. However, the policies do not offer sufficient protection for whistleblowers concerned about retaliation from agency officials.

You can read the complete joint report here.

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Creative Commons License"US Congress Committee Issues Report On “Highly Invasive” FDA Surveillance Of Employees" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Filed Under: IP-Watch Briefs, IP Policies, Language, Themes, Venues, Access to Knowledge/ Education, Biodiversity/Genetic Resources/Biotech, English, Health & IP, Human Rights, Information and Communications Technology/ Broadcasting, North America, Patents/Designs/Trade Secrets, Regional Policy

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