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FDA Surveillance Threatened Whistleblowers

Congress and the President must mandate a government-wide policy to prevent future surveillance abuses, Angela Canterbury, Director of Public Policy at the Project On Government Oversight, told the House Oversight and Government Reform Committee Wednesday during a hearing entitled “Limitless Surveillance at the FDA: Protecting the Rights of Federal Whistleblowers.”

The hearing revisited the media-dubbed case of the “FDA 9,” a group of Food and Drug Administration (FDA) physicians and scientists who wrote to Congress and the President in 2008 and 2009 warning that ineffective and unsafe devices were being approved by the FDA. The FDA whistleblowers described serious wrongdoing by mid-level and senior FDA officials who cut corners and overruled scientists. The FDA then began to spy on the whistleblowers—sweeping up whistleblowing disclosures to Congress, the Office of Special Counsel, and POGO.

The hearing was timed with the release of a joint staff report by House Oversight and Government Reform Chairman Darrell Issa (R-Calif.) and Senate Judiciary Ranking Member Chuck Grassley (R-Iowa), titled “Limitless Surveillance at the FDA: Protecting the Rights of Federal Whistleblowers.” The report concluded that the FDA lacked sufficient authorization to monitor the whistleblowers, unlawfully captured protected communications of the whistleblowers, failed to explain how ongoing monitoring was necessary to the investigation of a past leak, and did not adequately bolster whistleblower protections in new policies.

Ranking Member Elijah Cummings (D-Md.) introductory remarks voiced his discontent at being shut out of the drafting of the report. “We must protect our whistleblowers. I am committed to that, and we are all committed to that. Unfortunately, the majority has taken a traditionally bipartisan issue, something that all committee members should be investigating together, and turned it into another partisan spectacle for which our committee has become well-known.”

Chairman Issa responded, “Whistleblowers made Senator Grassley and his staff aware of a problem, but independent investigation by the IG and by this committee—bipartisan investigation—have led us to the conclusions we will hear today.”

The minority may produce its own report on the findings in the coming weeks.

Senator Grassley testified first, stating, “In 33 years, under both Republicans and Democrats, I’ve found the problem the same. Whatever bureaucracy you’re talking about, whistleblowers are about as welcome in a bureaucracy as skunks at a picnic.” On the FDA specifically, he said, “We have found problems with the respect of scientists and the respect of the scientific process within that agency regardless of who was president.” You can watch the Senator’s full testimony here.

Discussing the alleged confidentiality of the information shared by the whistleblowers, Chairman Issa emphasized that the trade secrets being protected by confidentiality claims protect the companies, not the public. “Most people probably listening and watching and today believe the public has a right to know that information and may not agree with the FDA’s view that that is private or confidential or somehow a secret from the American people as to whether a product that may or may not yet be on the market is safe and effective.”

Canterbury agreed with the Chairman’s concerns, and later noted that neither the Issa-Grassley nor the Health and Human Services Inspector General (HHS IG) investigation confirmed that the FDA surveillance found evidence of the disclosure of confidential information. Moreover, whether the information was confidential should have been investigated—instead of the whistleblowers.

Canterbury also said that protecting whistleblowers at the FDA may be a matter of life and death for many Americans:

Whistleblowers are the guardians of the public trust and safety. Without proper controls at FDA and throughout the government, employee surveillance is a serious threat to whistleblower protections. The resulting chilling effect will significantly reduce accountability—thus keeping waste, fraud, abuse, and threats to public health and safety in the shadows.

“The FDA’s problems can be deadly. There have been far too many ineffective and unsafe medical devices approved by the broken agency,” Canterbury said.

Unfortunately, there have been multiple instances of misconduct in the medical device approval process at the FDA in the past few years. In February 2009, POGO issued a report authored by Dr. Ned Feder, The FDA’s Deadly Gamble with the Safety of Medical Devices, which showed that senior FDA officials decided not to enforce a regulation that helps protect patients from unsafe devices. The officials did this over the protests of scientists.

Canterbury told the committee that unwarranted surveillance is a serious threat and government agencies should not be allowed to police themselves. She noted that only law enforcement, such as the FBI, Office of Special Council, and Inspector General, should investigate suspected leaks of legally protected information or other crimes.

The HHS IG, the watchdog tasked with oversight of the FDA, released its report on the surveillance of the whistleblowers the night before the hearing. The report pointed to FDA’s failure to consider whether potentially intrusive monitoring would be “the most appropriate investigative tools” with which to investigate a suspected leak.

However, Canterbury strongly disagrees with the HHS IG’s conclusion that the FDA’s interim policies are sufficient to protect the constitutional and whistleblower rights of employees, and therefore the public’s health and safety. “Congress protected public whistleblowing because we live in a democracy that relies on an informed public and freedom of the press. In numerous instances, threats to public health and safety, waste, fraud, and abuse and other wrongdoing would never have come to light or been addressed without public whistleblowing.”

Canterbury ended her testimony by urging the committee to hold FDA officials accountable for any violations of rights against employees who sought to make medical devices safer and more effective.

“And please make sure it can’t happen again,” she said.

You can watch Canterbury’s opening statement here or read her full written testimony here.