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Entries in Food and Drug Administration (2)

Thursday
Jul192012

FDA Insists It Only Spied on Five Scientists

MANDEL NGAN/AFP/Getty Images(WASHINGTON) -- The Food and Drug Administration denies that it targeted more than five of its scientists or any congressional staff, outside medical experts or journalists in a surveillance operation to identify who leaked confidential information to the media.

Sen. Charles Grassley, R-Iowa, called on the Justice Department this week to investigate what he deemed the FDA's "targeted spy ring" after thousands of documents collected by the agency's monitoring software was surreptitiously posted online last week, allegedly by accident.

The documents, which were first reported by The New York Times, had been collected from the government-issued computers of five FDA scientists who alleged that the oversight agency was approving medical devises that expose patients to dangerous levels of radiation.

That trove of information suggested that the spying operation extended not only to the five scientists, but included a list of 21 FDA employees, congressional officials, outside medical researchers and journalists that were thought to be putting out "defamatory" information about the FDA, the Times reported.

FDA spokeswoman Erica Jefferson said the agency is investigating the "data breach" and that the "enemies list" that the Times reported was "merely an internal summary of who the employees were corresponding with."

Grassley said the documents, which were hastily taken offline last Friday, made the FDA "sound more like the East German Stasi than a consumer protection agency in a free country."

In the documents, the agency referred to whistleblowers as "collaborators," called congressional staffers "ancillary actors," and dubbed journalists "media outlet actors," Grassley said Tuesday in a statement.

Because the scientists were using federally-issued computers, the FDA could legally track any emails sent on them.  The agency could not, however, specifically target emails between its staff and Congress, the Department of Justice and the staff members' attorneys.

"Secret monitoring programs, spying on Congress and retaliating against whistleblowers -- this is a sad commentary on the state of affairs at the FDA," Grassley said Tuesday on the Senate floor.

Jefferson denied that the agency targeted congressional communications.

"Neither members of Congress nor their staffs were the focus of monitoring," Jefferson said in the statement.  "At no point in time did FDA attempt to impede or delay any communication between these individuals and Congress."

Only one of the scientists targeted by the FDA's spy software still works for the agency.  The other four were either fired or their contracts were not renewed.

All five of the spied-on scientists are now suing the agency for violating their constitutional rights to privacy and for stealing their private information, such as passwords to online banking sites that could have been recorded by the monitoring software.

"There were no boundaries in FDA," said Stephen Kohn, the lawyer representing the FDA scientists.  "What started as a leak investigation metamorphosed within weeks to an explicit campaign to intercept communications to Congress."

The FDA denied that it recorded any such passwords.

Copyright 2012 ABC News Radio

Monday
Oct312011

Obama Orders FDA To Curb Drug Shortages

File photo. (Kevin Lamarque-Pool/Getty Images)(WASHINGTON) -- President Obama has signed another executive order, this one directing the Food and Drug Administration (FDA) to take action to reduce prescription drug shortages, which the White House says have endangered patients and led to price gauging.

“Recently we have seen how the potential of drug shortages for vital drugs, including some cancers, can really have an adverse impact on patients and those who are caring for patients, President Obama said at the signing Monday in the Oval Office. "Sometimes we run out of or run low on certain types of drugs and that drives up prices and it increases patient risk.” 

The new Executive Order instructs the FDA to take action in three areas: broadening reporting of potential drug shortages, expediting regulatory reviews that can help prevent shortages, and examining whether potential shortages have led to illegal price gouging.

According to the White House, these additional steps will help achieve some of the goals of bipartisan legislation currently in Congress that would strengthen the FDA’s ability to prevent prescription drug shortages in the future. The president supports the pending legislation.

What the executive action does not do, however, is give the president any new authority. White House officials Monday made clear that this action simply “enhances” and “amplifies” steps that are already being taken by the FDA to monitor and prevent drug shortages.

“The executive order does not grant us new authority beyond what the legislation on the books has already done,” HHS Secretary Kathleen Sebelius told reporters on a conference call Monday afternoon.

In addition to expediting review of drug suppliers and new manufacturing sites to prevent shortages, the administration also announced it is adding five new staffers to the FDA’s Drug Shortages Program and sending a letter to manufacturers to remind them to report the discontinuation of certain drugs.

Monday’s action is part of the president’s continuing “we can’t wait” campaign to take unilateral action to boost the economy without seeking the appoval of Congress, which has failed to support the president’s $447 billion jobs bill.

Copyright 2011 ABC News Radio







ABC News Radio