Regulatory Focus™ > News Articles > Pressure Mounts on FDA Over Surveillance Scandal

Pressure Mounts on FDA Over Surveillance Scandal

Posted 17 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is facing mounting pressure from both Congress and outside groups after The New York Times published an exposé on a clandestine monitoring program at the agency.

The entire case stems from a report in January 2012 by The Washington Post, which revealed that a group of former FDA medical reviewers had filed a lawsuit against the agency for allegedly intercepting communications between them and outside oversight entities, including congress, the Office of Special Counsel, executive staff and others.

Media regarding the case had largely died down since The Post's report, and the next expected developed was to occur on 23 July when The National Whistleblowers Council (NWC)-a whistleblowing advocacy and legal group representing several of the affected FDA staff members-was expected to appear in court in support of its Motion for Preliminary Injunction seeking information related to the surveillance program.

If FDA staff were hoping to leave the courts to make most of the news, those hopes were dashed on 14 July when The Times published a review of nearly 80,000 files inadvertently placed online by a contractor handling legal documents for FDA. The files not only revealed widespread efforts to track the activities of the staff scientists, but also to assess and track communications between congressional staff and members of the media.

Media Group Calls for Audit of Agency

While The Times characterized the efforts as constituting an "enemies list of sorts," the President of the Association of Healthcare Journalists (AHCJ), Charles Ornstein, went one step further.

"We urge you to take immediate action to end these Orwellian practices," wrote Ornstein in a letter to Department of Health and Human Services' Secretary Kathleen Sebelius, referring to George Orwell, author of the dystopian novel 1984.

Ornstein said his group, which represents journalists covering topics related to health care, was "deeply disturbed by the revelations."

"[The Times] story confirms our worst fear: that the pushback on journalists seeking information from HHS and its agencies, coupled with covert monitoring of scientists' communications with journalists and elected representatives, reflects a culture of cynicism within your department toward the principles of open government, free speech, and the public's right to know," Ornstein wrote in a letter to Kathleen Sebelius, Secretary of the Department of Health and Human Services.

Ornstein further asked Sebelius to conduct an "audit of all HHS decisions to see how widespread this monitoring is and to suggest ways to make sure it never happens again." DHHS is already scheduled to release a report on the surveillance issue within the next several weeks, though it is unclear whether it will extend its deadline to accommodate new facts or it was previously aware of the information made public by The Times.

Congressmen Register Outrage

Several prominent congressmen were quick to register their outrage in the wake of The Times' article. Senator Charles Grassley (R-IA), who along with House Oversight Committee Chairman Darrel Issa (R-CA) has been investigating the allegations against FDA for months, went further than Ornstein in his use of historical metaphors.

"FDA has absolutely no business reading the private e-mails of their employees," said Grassley in a statement to The Times. "They think they can be the Gestapo and do anything they want."

Congressman Chris Van Hollen (D-MA), who was revealed by The Times to have been placed on a list of "ancillary actor[s]" by FDA, also registered his displeasure at the new revelations.

"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," remarked Van Hollen, who found himself ranked as an "ancillary actor" on one of FDA's lists. Any communications by FDA staff with the "ancillary actors" would reportedly trigger a heightened review of FDA staff, reported The Times.

New Details Emerge

Grassley also revealed new details on 16 July indicating he had information stating the surveillance program had been "explicitly authorized, in writing, by the General Counsel's office."

The General Counsel's office is a division of the Office of the Commissioner, and its Chief Counsel, Elizabeth Dickinson, reports directly to Commissioner Margaret Hamburg. The scope and duration of the monitoring program-started in 2010-raises the possibility that Hamburg herself may have at one point signed off on the program or had knowledge of it-a likely political liability given the outrage of some legislators and members of the media responsible for covering the agency.

To date, there has been no information regarding who, specifically, authorized the surveillance of FDA staff. This, too, has left Grassley irate. "It is simply not credible that FDA went to such great lengths over the course of two years to monitor employees' personal e-mail accounts, then spent six months crafting a reply to my questions about it, and yet still cannot identify who authorized the spying," said Grassley to The Washington Post.

FDA's assistant commissioner for litigation, Jeanne Ireland, told The Washington Post on 17 July that the surveillance program has since been shut down, though no specific time frame for the cessation of the program was given.

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