Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health of the FDA

There has been minimal news coverage of a congressional committee hearing that was held yesterday on a surveillance operation the Food and Drug Administration (FDA) conducted against five employees who were making whistleblower complaints and yet the nature of what the FDA did exemplifies a key problem with government agencies currently.

Administrators of agencies or departments in the United States government think they get to determine what is and is not a whistleblower disclosure yet, by law, they do not get to decide.

The FDA violated the Privacy Act of 1974 and disclosed records collected in their surveillance operation to agency and non-agency employees who had “no need to review the records.”  A US Department of Health and Human Services (HHS) contractor, Quality Associates, Inc, obtained 80,000 pages of documents “associated with FDA employee monitoring” and, in May 2012, posted them on a public Internet site. These records included “confidential and proprietary FDA documents, as well as confidential communications between FDA employees and Congress, the Office of Special Counsel (OSC) and personal attorneys.” This happened because the FDA did not appropriately ensure it was not collecting such communications that should have been respected as private.

It engaged in the targeting of individuals making whistleblower complaints because GE Healthcare expressed concern over an alleged “violation of confidentiality” when the New York Times published a story on March 28, 2010, on FDA’s approval process for medical devices and  requested an “internal investigation into how this information was leaked to the press.” (More on exactly what happened and the extensive nature of surveillance imposed on targeted employees can be found here.)

But Democrats on the House Oversight & Government Reform Committee and others in Congress, which held this hearing, contest the joint report put out by House Oversight and Government Reform Committee Chairman Darrell Issa and Senate Judiciary Committee Ranking Member Chuck Grassley.

Ranking Member and Democratic Representative, Elijah Cummings, maintained during the hearing on February 26 that the report was another result of partisanship by Republicans. Democrats had tried to interview FDA employees, who were subject to surveillance, to hear their concerns and also “confront them on evidence” that may have contradicted their accounts of what happened. They maintained that leadership of the committee had not allowed this to happen and also that the inspector general for Health & Human Services had finished an investigation. He was poised to release findings from the investigation and it was upsetting that Oversight & Government Reform Committee had proceeded with this hearing without waiting for it to be completed.

Cummings, quoting from the report, said, “The FDA had reasonable concern that confidential information including possibly trade secrets and/or confidential commercial information had been disclosed by agency employees without authorization.” He said the IG stated “companies that submitted applications asked the FDA to investigate which employees leaked their trade secrets and confidential commercial information in violation of the law.” The IG found that the “FDA had provided notice to a scientist and all other users of the network through a network logon banner that there was no right to privacy on the FDA computer network and that all data on the network was subject to interception by the FDA.”

There was no evidence that FDA monitored employees to “retaliate against them.” The agency had a “reasonable basis for initiating” monitoring because the disclosures were of a nature that were likely “prohibited by law” and employees could be “subject to criminal penalties.” However, the IG added the FDA had not ensured surveillance would not collect communications with Congress, inspector generals, lawyers, etc.

“The FDA should have assessed beforehand and with the assistance of legal counsel whether potentially intrusive Encase [software],” the IG concluded. They did not examine whether monitoring would be the most appropriate investigative tool and how to ensure that the use of these tools would be consistent with constitutional and statutory regulations on government searches.

Yet, why did the tools have to be used at all? What was this information the FDA was willing to protect on behalf of a big corporation, General Electric?

Issa, despite his record of doltish and bullheaded overzealousness, made an important point during the hearing. The information at issue that was disclosed was not patent information. It was not some “deep dark secret.” It related to a question of whether or not medical devices were safe and effective.

As the Times reported, agency documents provided to the media organization suggested that FDA managers “sought to approve an application by General Electric to allow the use of CT scans for colon cancer screenings over the repeated objections of agency scientists, who wanted the application rejected.”

…Dr. Julian Nicholas, a gastroenterologist who trained at Oxford University and the Mayo Clinic and worked under contract with the agency, responded by e-mail that he felt strongly that approving the application could “expose a number of Americans to a risk of radiation that is unwarranted and may lead to instances of solid organ abdominal cancer.”

Dr. Robert Smith, a former professor of radiology at both Yale and Cornell and an F.D.A. medical officer, wrote that he agreed with Dr. Nicholas because “the increased radiation exposure to the population could be substantial and would raise a serious public health/public policy issue,” documents show…

Nevertheless, Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health of the FDA, stated during the hearing “whether or not the product was under review” has typically been “considered confidential. Companies many times do not want competitors to know that they’re working on the product and that it’s under review by the agency.”

Issa tried to explain that most Americans would not think details on clinical trials, processes for approval and questions related to reviews need to be kept secret because it is proprietary.  ”The public has the right to know that information and may not agree with the FDA’s view that is private or confidential or somehow a secret from the American people as to whether a product that may or may not be on the market is safe and effective,” Issa added.

Shuren added, “Our employees know that information is confidential, and that has been for long standing time. Keeping that information confidential is critically important. It can undermine ongoing review of medical device applications. In fact, I believe in that particular case it, in fact, did that. It undermines our medical device program.” Keeping the information confidential is necessary for the review program.

He also said companies rely on FDA protection. If the agency doesn’t protect information, the companies don’t bring innovative technologies to the US. Patients lose.

This is only necessary if any amount of transparency brought to the review process would jeopardize potential profits for a corporation like General Electric. If the corporation—and regulatory agency—is doing nothing wrong, there is no reason to make secrecy such a high priority.

Angela Canterbury, director of public policy for the Project on Government Oversight (POGO), posed the question, “Why is this information considered confidential in the first place and is that serving the public health and safety?” Why did the FDA not first verify whether it was legitimate for the information to be considered confidential? Because that is the issue from which all of this stems.

Furthermore, Issa asked if companies sign a “gag order” to prohibit disclosure of information on approval processes. Shuren said, “No, they may disclose it.”

Cummings, who believes it was reasonable for FDA to investigate and target these employees, questioned Shuren on his “duty” and “obligation” to look into unauthorized disclosures. Companies had complained because they did not expect to read about their product in the Times. They claimed it was a violation of federal law.

This exchange Cummings had with Shuren led into another key aspect of this story. Shuren said he didn’t think the employees making complaints about the medical devices had “valid” concerns. This was a machine for screening “symptomatic patients for cancer” and “a joint meeting of two advisory committees” had “unanimously” determined it should remain an option.

Is not this the key problem with whistleblower protection today? An agency or department can use intrusive and unrestrained surveillance to target employees who are communicating to Congress or their attorneys about issues or activities within the agency they have good faith to believe are improper or wrong. The agency or department administrators do not believe the whistleblower complaints are valid and they want to stop those complaints from having any public impact. They clampdown and, in the clampdown, the individuals making complaints allege retaliation. But, because the complaints are not considered valid to administrators, the inspector general cannot validate claims of retaliation.

To an outside observer, it seems like there is a causal relationship. The administrators, however, never intended to stop a “whistleblower act.” They aimed to stop a leak of confidential or secret information that should not have occurred (in their opinion). They operate with the presumption that they have complete authority to take whatever action to stop employees and they will clamp down because they have an overblown sense of what information must be protected by secrecy.

There is a bit of game theory that goes into the politics. In this case, Republicans find they can be on the side against what the FDA did. The Democrats have been convinced by the FDA that they meant to do no harm. There was no malicious intent in targeting the five employees. All of which obscures a key fact highlighted in the joint report from Grassley and Issa: “Whistleblower disclosures are protected by law, even if they are ultimately unsubstantiated, so long as the disclosure was made in good faith.”