FDA Monitors Scientists' Critical Emails

The Food and Drug Administration has been secretly monitoring the emails of its scientists, who had expressed criticism of the agency's review process for approving medical devices. The New York Times reported the FDA captured thousands of private communications involving the scientists and members of Congress, their lawyers and even President Obama. Steve Inskeep talks with Times reporter Scott Shane, who co-reported the story.

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STEVE INSKEEP, HOST:

The Food and Drug Administration has been secretly monitoring the emails of its own scientists with so-called spy software. The scientists under scrutiny have been criticizing their agency. They disagreed with the agency's review process for approving medical devices. In January, the scientists filed a lawsuit against the FDA when they learned that some of their emails had been intercepted. Now the New York Times is reporting the FDA actually captured thousands of private communications between the scientists and members of Congress, their lawyers, journalists, even the President of the United States. Scott Shane co-reported this story. He's on the line now. Good morning.

SCOTT SHANE: Good morning.

INSKEEP: What got the FDA started on this investigation anyway?

SHANE: Well, they had had some complaints from manufacturers of scanning equipment used in colonoscopies and that kind of thing, who said that in certain articles that were appearing in the press, notably in my newspaper, The New York Times, they thought there was proprietary information that they had provided to the FDA, private corporate secrets, essentially, to their machines. So they set out to find out whether that was true and whether indeed any FDA employees might be leaking proprietary information, either to the press or to other outsiders.

INSKEEP: Okay. So did this become an investigation of the leak of proprietary information, or an investigation of leaks that were embarrassing to companies and the FDA?

SHANE: Well, I think the - it does appear to have begun as a, you know, a legitimate exercise of FDA's right to look at the computers that it owns and that its employers were using to answer this question about proprietary information. But there were some documents that we looked at that were sort of strategy documents for this surveillance operation, that indicated it had gone considerably farther than that. And they included a list of 21 people, about half inside the agency and half outside the agency, who were identified as critics of the agency and they included a member of Congress, several Congressional staff members, a number of journalists.

So it was a sort of enemies list of the agency, and they were projecting, you know, how can we keep an eye on these folks. They weren't actually going inside the computers of journalists and members of Congress, but they were watching for their communications with the FDA employees.

INSKEEP: Did you make the enemies' list, Mr. Shane?

SHANE: I did not, but my colleague, Gardiner Harris - who covered the FDA for several years - was number one on the journalists' list.

INSKEEP: I suppose this is a reminder, and employers do say this to their employees from time to time, if you're at a company computer, and you send out an email or receive one, the company claims the right to look at that, and I guess the FDA as the employer of these scientists claimed that right and used it, as it's entirely legal.

SHANE: That's absolutely right. That part of it is legal, and in fact, the FDA pointed out that when an employee signed on to his or her FDA laptop, there was a sort of warning that flashed up that said this is FDA property and everything is subject to monitoring. But the problem is that there are also laws that protect the privacy of, for example, attorney-client privilege and some of these FDA employees were communicating with their lawyers.

There are laws protecting the privacy of communications - sort of whistle-blowing communications with Congress, with a whistle-blowing office within the government, and those are not supposed to be interfered with. So it seems that there are two interests in conflict, and that perhaps the FDA's operation went a little bit beyond where it really should have gone in terms of just looking for a leak of proprietary information.

INSKEEP: Well, how is the Food and Drug Administration responding to these charges?

SHANE: Well, they were very unhappy with what we were writing. I think they were in shock to some degree, because what happened was a contractor that is only assigned to, kind of, handle documents at the FDA, large quantities of documents...

INSKEEP: Mm-hmm.

SHANE: ...had accidentally put 80,000 pages up on the Web in a place where we were able to find these documents, and others were able to find them as well. So the proprietary information they were trying to protect had actually become public through this mistake of an FDA contractor.

INSKEEP: Awkward. Mr. Shane, thanks very much.

SHANE: Thank you.

INSKEEP: Scott Shane of the New York Times reporting on the Food and Drug Administration and its investigation of some of its own scientists.

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Source: http://www.npr.org/2012/07/16/156829995/fda-monitors-critical-scientists-emails?ft=1&f=1007

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