Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 24 July 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program.
Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by 24 August. All other documents will have to be made available by 10 September, notes Bloomberg Businessweek.
The initial materials are to be made available more quickly in the interest of expediency, added Bloomberg.
FDA's case may have been made more difficult after The New York Times discovered nearly 80,000 documents related to the case posted online by a contractor for the agency. Bloomberg notes that the information ordered released by the judge today doesn't include information accidentally released by FDA.
As the NWC's motion is also a Freedom of Information Act request, it remains likely that the request will eventually be made public, either by the agency or other parties.
As Regulatory Focusreported on 16 July, the NWC filed a lawsuit on behalf of the whistleblowers in May 2012 seeking to compel FDA to turn over "records concerning the warrantless surveillance program and to complete the processing of the documents within 40 days."
(For background information, please see Regulatory Focus' 16 July story, "Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices")
While the group's Motion for Preliminary Injunction was originally set to be heard by the US District Court of DC on 21 June, the case was pushed back until 23 July for unknown reasons.
The motion was the third lawsuit filed by NWC against FDA, with the first two lawsuits meeting with more limited success.
Read more:
Tags: NWC, FOIA, Whistleblowing, Surveillance, FDA Nine, Lawsuit, Court, Latest News