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 firstname.lastname@example.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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 25 February 2014 | By Alexander Gaffney, RAC,
If US Food and Drug Administration (FDA) officials thought they had finally moved past a scandal that has embroiled the agency's medical device division for years, they apparently thought wrong.
This piece has been updated with comment from FDA. See the FDA Comments' section. -Ed.
On 26 February 2013, the US House Oversight Committee is set to re-examine a 2012 scandal involving FDA's Center for Devices and Radiological Health (CDRH) in which the agency monitored several of its employees who were involved in whistleblowing against the agency.
Nine staff scientists employed by FDA had publicly raised concerns about the processes used to review imaging devices, and sought to re-review the products in light of those concerns. FDA eventually fired several of those employees.
Six employees later sued FDA, alleging that it had conducted surveillance of their communications without regard to their privacy rights under the law.
While the lawsuit eventually failed to advance, the saga left FDA's reputation badly damaged. In widely read reports in the New York Times, the agency was accused of keeping "enemy lists" of reporters and outside groups, as well as inadvertently allowing tens of thousands of legal documents to be leaked.
Legislators, including Charles Grassley (R-IA), repeatedly excoriated FDA for reportedly intercepting communications between the employees and members of Congress, and for keeping them categorized on lists as "ancillary actors" thought to be against FDA's interests.
"It's hard to see how managers apparently thought it was a good use of time to shadow agency scientists and monitor their email accounts for legally protected communications with Congress," Grassley wrote in a letter to FDA in January 2012.
"It is absolutely unacceptable for the FDA to be spying on employees who reach out to members of Congress to expose abuses or wrongdoing in government agencies," Rep. Chris Van Hollen (D-MD) told The Times.
The saga also roped in another federal agency, the Office of Special Counsel (OSC), a rarely utilized whistleblowing protection office. OSC ultimately used the FDA scandal to issue new guidance to all federal agencies underscoring the "right of federal workers to disclose wrongdoings without fear of retaliation."
OSC added that any monitoring conducted by agencies must be legitimate in purpose and not "chill employees from disclosing wrongdoing."
Later, Grassley and House Oversight Committee Chairman Darrell Issa would accuse FDA of "stonewalling" their investigation into the matter.
For its part, FDA said the entire matter was a legitimate exercise of its right to monitor its employees' communications and to protect the commercial properties of the companies that utilize its review pathways.
"There's a lot of misinformation that is out there and circulating," said FDA Commissioner Margaret Hamburg in a February 2012 interview. "At FDA, we take very seriously the responsibility to protect commercial and confidential information, and at FDA we do follow established guidelines and a legal framework for protecting certain kinds of data from inappropriate use and inappropriate distribution."
There's been little in the way of updates on the case since late 2012, when the whistleblowers' case appeared to fizzle out-whether for lack of evidence, interest or resources, it's not clear.
But for whatever reason, Washington-a town which seems to dart from one scandal to the next with lightning speed-appears to have not forgotten about FDA's whistleblowing saga.
On 26 February, the House Oversight Committee is set to hear from FDA and other officials in a hearing entitled, "Limitless Surveillance at the FDA: protecting the Rights of Federal Whistleblowers."
Calling FDA's surveillance "unprecedented" and "without regard" for their employees' whistleblowing rights, the committee said it will "examine the extent of the FDA's surveillance program and whether the FDA has taken appropriate steps to safeguard the rights of federal whistleblowers going forward."
In comments to Regulatory Focus, FDA spokeswoman Erica Jefferson defended the agency's conduct.
"The FDA has a legal obligation to protect sensitive, confidential commercial information and trade secrets," she wrote. "Whenever an individual logs onto the FDA computer system they are warned that their use of the system may be monitored, intercepted, or recorded in any manner and disclosed by and to authorized personnel. The agency works diligently to ensure that FDA employees are not subject to inappropriate monitoring and that monitoring is not conducted in a retaliatory manner."
Such information had been leaked by at least one of the employees to a New York Times journalist, BioCentury reported in 2012.
Jefferson also noted that FDA revamped its policies in September 2013 to better guard against unauthorized monitoring of protected communications.
At least three FDA officials are scheduled to testify: CDRH's Director Jeffery Shuren, Associate Director for Management Ruth McKee, and FDA's COO and Acting CIO Walter Harris.
The House committee hearing will also feature an unusual witness: Sen. Charles Grassley, who is likely to be less than kind to FDA during the hearing given his past remarks.
A fifth witness, Angela Canterbury, is with the Project on Government Oversight.
Tags: House Oversight Committee, FDA Nine, Charles Grassley, Whistleblower, House, Jeffery Shuren
Regulatory Focus newsletters
All the biggest regulatory news and happenings.