FDA and CDRH officials are facing escalating pressure following the accidental public release of thousands of emails and documents captured by agency surveillance of CDRH scientists who complained to Congress and others about the device review process.

Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some FDA watchers, both from industry and consumer advocacy groups, worry the intensifying issue has serious implications for the quality of the device center’s output.

FDA maintains that the monitoring of the staffers’ email and computer activity was legal and limited in scope to five current and former CDRH employees who were being investigated for leaking proprietary commercial information related to pre-market submissions for imaging devices to the press and others.

However, a recent accidental and unauthorized release of thousands of pages of computer documents generated by the two-year surveillance effort have bolstered the scientists’ claims that the effort was more expansive than FDA says it was and that it captured legally protected information, such as attorney-client communications.

“These memos make the FDA sound more like the East German Stasi than a consumer protection agency in a free country” – Sen. Chuck Grassley

Fulton, Md.-based Quality Associates, a company contracted by FDA to handle documents captured in its surveillance efforts, accidentally posted the materials online. The documents were removed July 13 following inquiries by The New York Times, but according to a July 14 report in the Times, the documents contain day-by-day communications of the CDRH scientists, including legal filings, personal emails, and discussions with congressional officials and members of the media. They also include confidential information on the design of imaging devices, according to the Times.

FDA, which says it is investigating the release of the files, insists that its effort did not target members of Congress or the press, and was not intended to impede communication between agency staffers and Congress, which is protected by whistleblower statutes. It was limited to determining whether confidential commercial information, which the agency is legally required to protect, had been “inappropriately released to the public,” an FDA spokeswoman said.

But several members of Congress stepped up criticism of FDA management in the wake of the latest disclosures, charging that FDA obstructed the activities of whistleblowers and may have acted illegally.

Sen. Chuck Grassley, R-Iowa, who has frequently been critical of FDA’s whistleblower policies and whose staff has been investigating this matter, said in a July 17 Senate floor speech, “These memos make the FDA sound more like the East German Stasi than a consumer protection agency in a free country.”

Grassley has referred the matter to both the HHS Office of Inspector General (OIG) and the Department of Justice to further investigate whether CDRH employees’ whistleblower rights were violated, according to a July 16 letter Grassley sent to FDA Commissioner Margaret Hamburg. The Senator is also seeking details about who authorized the surveillance program and other information, and says he is dissatisfied with responses so far from FDA about the program.

In addition, the U.S. Office of Special Counsel (OSC), which looks into complaints by federal agency employees, is conducting an investigation of the surveillance matter. And FDA faces an ongoing federal lawsuit from six current and former CDRH employees. The suit alleges that the monitoring violated the employees’ constitutional and legal whistleblower rights, and that FDA relied on the captured electronic data to support the firing of four of the plaintiffs. (See Also see "CDRH Spyware Suit: Whistleblowers Sue Agency Over Email Surveillance" - Medtech Insight, 6 February, 2012..)

The matter has also apparently opened official questions about FDA’s review of certain imaging devices. In addition to the surveillance issues, OSC investigated the review-process complaints from the whistleblowers, specifically that CDRH managers “ignored and suppressed” significant public health concerns with imaging systems that were under review, including the radiation risk from using computed tomography to screen healthy patients for cancer. (See Also see "Device Center Detractor Speaks Out At FDA Radiation Meeting" - Medtech Insight, 5 April, 2010..)

According to an amended complaint filed July 17 in the whistleblowers’ lawsuit against FDA, OSC completed its investigation at the end of May into the FDA review process and safety for two devices – a CT colonography device from GE Healthcare and an imaging device known as “CARESTREAM.” The OSC found that there was a likelihood that the concerns raised by the reviewers disclosed “a violation of law, rule or regulation, gross mismanagement, and a substantial and specific danger to public safety,” the complaint states.

In response to a request from OSC, HHS asked OIG in June to investigate the pre-market review process for some of the medical device applications to which the whistleblowers had expressed safety concerns, according to a July 13 FDA letter sent to Sen. Grassley.

Chilling Effects On CDRH Staff?

The current and former reviewers suing FDA allege that the computer surveillance activity first began in January 2009 after they had sent a letter complaining to then-President-elect Barack Obama’s transition team that FDA managers had “ordered, intimidated and coerced” scientists into modifying evaluations. (See Also see "CDRH Staffers To Obama: House Cleaning Urgent At Device Center" - Medtech Insight, 12 January, 2009..)

However, FDA says the effort didn’t begin until April 2010, after FDA received a letter from GE Healthcare alleging that confidential company information had been leaked by FDA to The New York Times and appeared in a March 2010 article. The agency says it only monitored the staffers’ use of government computers, which warn users that there is no expectation of privacy of data on the computers or network. (See Also see "Device Center Detractor Speaks Out At FDA Radiation Meeting" - Medtech Insight, 5 April, 2010..)

FDA now says the surveillance effort has ended, but the full implications of the program and the resulting scrutiny still remain to be seen.

“The current work environment at CDRH and its psychological impact on the staff could be a box office hit this summer as a disaster film or maybe a horror story,” said former FDAer Casper Uldriks.

“I think it’s an unfortunate moment in the history of CDRH that they are having to cope with this kind of situation,” said Casper Uldriks, a former associate director in CDRH’s Office of the Center Director, in an interview. “I think it has a very chilling effect. It’s putting progress in a glacial pace in terms of free exchange of thought amongst the scientists.”

Uldriks, now an attorney with Olsson Frank Weeda Terman Matz law firm in Washington, D.C., said he found the surveillance to be “egregious” and that he’d never seen such a tactic used by the agency.

Michael Carome, the deputy director of Public Citizen’s Health Research Group, says the surveillance effort could deter FDA employees from “raising and bringing to [Congress’] attention serious public health concerns related to the review of a medical device.”

“Obviously, that could have an adverse effect on public health by preventing valid concerns about medical device safety from being aired in a transparent way, and addressed appropriately,” he said in an interview.

But device industry attorney Mark DuVal looks at the situation from a different viewpoint, based on concerns that renegade agency staffers sometimes hold up reviews with questions to companies not required under FDA statute. (See Also see "Device Center Discord: 510(k) Review Process Is Flash Point At CDRH" - Medtech Insight, 16 March, 2009..)

Such reviewers might be emboldened by the attention given to these CDRH whistleblowers, and in turn management may begin to feel the pressure to meet reviewers’ demands to avoid whistleblower complaints, said the president of Minneapolis-based DuVal & Associates.

“Before this was ever announced, I can tell you former FDAers and some current FDAers have confided to me that it’s a concerning environment to be in management when you know that just because you disagree with a reviewer or a review staff, that that could potentially result in a letter to the President or Congress. That has a chilling effect on a management wanting to do the right thing,” DuVal said in an interview.

Concerns were also raised that the surveillance scandal could cause an exodus of CDRH employees and discourage people from joining the agency.

“The current work environment at CDRH and its psychological impact on the staff could be a box office hit this summer as a disaster film or maybe a horror story,” Uldriks said. “As a practical matter, this is not an effective tool for attracting prospective scientists.”

Diana Zuckerman, president of the consumer group National Research Center for Women & Families, added, “CDRH is already a place where most people don’t want to work for a variety of reasons, and this is going to make it that much worse.”

“Who would want to go to work for FDA?” she asked. “It would hopefully be somebody who has an interest in protecting the public health. You don’t want to go to a place if you feel that if you find something that concerns you, you can’t express it and you could get fired if you do.”

Pressure Mounts On FDA After Public Release Of Surveillance Documents

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