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FDA’s E-Mail Scandal: First Impressions

According to the New York Times, FDA collected more than 75,000 employee e-mails in an effort to identify leaks of confidential trade secret information. At some point, a narrow, possibly legitimate inquiry into a handful of scientists at the Center for Devices and Radiological Health (CDRH) turned into a massive e-mail surveillance of selected individuals and their contacts.

So far, FDA is not contrite. FDA’s position, while still not quite official, appears to be: we tried to accommodate these individuals’ complaints within the personnel and dispute resolution systems. We had legitimate concerns that trade secrets were leaving FDA in their correspondence with third parties.

FDA Matters believes we don’t know the whole story yet.

The immediate perception is that the agency–in the name of protecting trade secrets–targeted internal critics and found ways to monitor their strategy and actions.

Fueling concerns is that a number of the monitored e-mails were sent to media, the President, and Members of Congress. Among others, Republican Senator Charles Grassley and Democratic Congressman Chris Van Hollen, have expressed concerns that correspondence with their staffs had been part of the surveillance.

Further, the surveillance appears to have included correspondence with the Office of Special Counsel, an independent federal investigative and prosecutorial agency with jurisdiction to oversee whistleblower complaints. Understandably, they are unhappy when they perceive that other federal agencies are interfering in their investigations.

In short—even with Congressional recess coming up and a national election—this issue is not likely to go away.

Every day FDA receives confidential trade secret information that it is legally obligated to protect. Any individual failing to do so is open to penalties—I assume both criminal and civil. To me, the key paragraph of the NY Times story is this one:

F.D.A. officials went to the inspector general at the Department of Health and Human Services to seek a criminal investigation into the possible leak, but they were turned down. The inspector general found that there was no evidence of a crime, noting that “matters of public safety” can legally be released to the news media.

 

Undeterred, agency officials began the electronic monitoring operation on their own.

If true, this is quite damning of the agency and provokes the usual question of why senior FDA officials did not exercise more restraint and better judgment.  

However, the agency’s unofficial semi-response suggests that this is not the full picture. At some point, the Office of General Counsel (OGC) at FDA became involved and authorized surveillance. Assuming this is true, did OGC have the authority to do so…and did they know that they were authorizing a broad surveillance? (I refuse to think of 75,000 e-mails as a narrow search).

According to an on-line Wall Street Journal article, the key individual in this case is a “serial whistleblower” (my term, not theirs), having filed lawsuits at two previous jobs. Supposedly, in both cases, the allegations of institutional misconduct were not proven in court, but he received settlements for “wrongful terminations” that followed his whistleblowing. What happened previously and elsewhere is irrelevant, except perhaps to remind us how hard it is for government agencies and public entities to fire an employee who they believe to be a disruptive force.

There is no way that FDA can look good if it is seen as approving devices that should not be on the market, squelching internal scientific disagreements, pursuing vendettas against its employees, or interfering with the prerogatives of Congress and the Office of Special Counsel.

In the face of all of this—the allegations and FDA unwillingness or inability to respond fully–it is hard not to worry about the agency. It is an institution that badly needs public and congressional support to do its job, especially when its responsibilities are growing and its budget isn’t.

FDA Matters hopes that Commissioner Hamburg and her senior staff are able to respond more fully and “on the record” in a way that helps stakeholders, Congress, the media and OSC understand why the extensive surveillance became necessary and what public purposes it served.

Steven

Here is more background, provided as a courtesy by BioCentury:  http://www.biocenturytv.com/freecontent/tbr_072312.pdf.

Some of the other relevant documents available only through subscription trade media:

 

1/ FDA’s response to Senator Grassley is available from Inside Health Policy (www.insidehealthpolicy.com, by subscription) at: FDA letter to Grassley.

 

2/ According to Dickinson’s FDA Webview (www.fdaweb.com, by subscription) Commissioner Hamburg on 7/17/12 sent the following email to all employees:

 

Over the past few days, a handful of stories, first appearing in The New York Times, were written regarding the agency’s monitoring of the computers of five CDRH employees.

 

I want to reinforce that the FDA’s greatest strength is our people. I value the expertise, professionalism and dedication each of you brings to this agency every day. There is no greater mission than that with which we are charged – protecting the public health. I have great confidence in FDA’s leadership and employees, and we have worked hard to foster a culture where differing opinions on scientific data, regulatory issues and product approvals may be expressed freely. In addition, employees have avenues available to them to voice their concerns both inside and outside the organization without disclosing proprietary information that is protected by law from unauthorized disclosures. I want to reiterate the FDA's commitment to protecting the rights of whistleblowers who are doing a service by bringing public safety concerns to the forefront. It is only in working together with the highest levels of professionalism and ethics that we will continue to achieve our mission.

 

Regarding the recent news stories, I want to stress that the FDA’s ability to fulfill our mission of protecting and promoting public health necessarily relies upon our ability to protect confidential information. Protecting such information in our possession allows us to work with industry and other stakeholders to ensure the quality of FDA-regulated products and the integrity of FDA-decision-making.

 

In 2010, the agency initiated monitoring limited to the government-owned computers of five CDRH employees. The impetus for the monitoring was a March 2010 New York Times article and a letter from GE Healthcare that indicated a pattern of unauthorized disclosures of confidential information related to pending medical device applications and submissions over the course of more than a year. The intent of the monitoring was to determine whether confidential commercial information had been inappropriately released and to stop any further unauthorized disclosures, since any such disclosures are a violation of the law.

 

Although the FDA, as with other federal agencies, has the discretion to conduct appropriate monitoring of government computers, we do so only in very limited circumstances. We do not take lightly the decision to monitor government computers.

 

I hope this note offers a bit more context to the situation. We will continue to update you as best we can. Please be assured that your work and your opinions are appreciated.

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