Entries in FDA (5)


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


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


FDA Budget Hearing Turns from Money Talk to MTV's 'Skins' 

Adam Gault/Thinkstock(WASHINGTON) -- In the future, your children might not see commercials for chocolate milk, graham crackers, and Cheerios during breaks from their favorite television shows, prompting a House subcommittee chairman to take issue with some proposed guidelines regulating the marketing of food to children.

“I’m concerned about the potential overreach based on these guidelines that are sitting on the table right now,” Rep. Jack Kingston, R-Ga., said at a hearing on Capitol Hill Friday.  “The food that would not be allowed to be advertised on television shows in which 50 percent of the audience is children could include peanut butter sandwiches, eggs, granola bars, noodles, chocolate milk, pretzels, cheerios, bread, graham crackers and cheese.”

At a hearing mainly focused on the FDA’s budget, Kingston took a moment to go after the “Nanny State,” pointing to the disparity in banning television advertisements for certain foods while still airing controversial shows like MTV’s Skins, a show he described as a “soft porn titillating type show,” which he claims to have never watched but channel surfed through.

“What does the ‘Nanny State’ want?” Kingston asked. “Look at a review of the show Skins and think, we’re saying fine you can watch it  -- freedom of speech, parental control. I’m not here knocking Skins, but I’m saying it’s ironic that you can watch Skins, but Cheerios can’t be advertised on it because that might really hurt our teenagers, not the fact that they’re all running around in skimpy little clothes doing naughty little things.

FDA Commissioner Margaret Hamburg testified before a House Appropriations subcommittee to defend the 30 percent increase in the FDA’s budget proposed in the President’s FY 2012 budget, saying it will provide support to an “underfunded” and “under resourced” department.

“FDA’s charged with an enormous and unique set of tasks,” Hamburg said.  “If we do not do our job and do it completely, there is no other agency or entity out there to backstop us.  That’s why I am here to ask for your support of the Fiscal Year 2012 budget for the FDA.”

The President’s budget request would raise the FDA’s budget to over $4.3 billion.  The President also requested $183 million to implement the Food Safety Modernization Act, which, Hamburg argued, the FDA would be severely hampered in implementing should Congress not appropriate the funds.

Copyright 2011 ABC News Radio 


Food Safety Bill Passes Senate in Unexpected Last-Minute Move

Photo Courtesy - Getty Images(WASHINGTON) -- In an unexpected move, the Senate Sunday passed a sweeping food safety bill by unanimous consent, sending the bill back for a vote in the House before it can move on to President Obama’s desk.

The surprising development is only the latest bizarre twist for the measure.  Just a few days ago the food safety bill was seen as dead on Capitol Hill, but the Senate modified it to resolve a revenue technicality and managed to pass it.  The modification means it has to return to the House.  The revenue issue is key in the long bizarre story of the bill.

In July 2009, the House first passed the bill, aiming to prevent massive outbreaks of tainted food by giving the Food and Drug Administration the authority to order mandatory recalls and require more frequent inspections of high-risk food processing plants.  But the bill then languished in the Senate for 15 months in the face of opposition from Republicans who objected to it adding around $1.5 billion to the deficit.

Sen. Tom Coburn of Oklahoma argued that the bill needed to be fully paid for and do a better job of addressing regulatory failures.  However, in November, the Senate finally passed the food safety bill.

Except for one problem.  A tax provision included in the Senate bill violated the revenue rule, so instead of being sent to President Obama’s desk, the bill remained stuck in Congress.

The Senate then put the food safety bill into the massive $1.1 trillion year-end omnibus bill, giving supporters of the measure renewed hope that it might still get passed after all.  But no.

Last Thursday, Senate Majority Leader Harry Reid, in the face of widespread GOP opposition, decided to scrap the omnibus bill in favor of a short-term continuing resolution to fund the government into early 2011.  At that point the food safety bill was considered dead.  Until Sunday’s surprising development in the Senate, that is.

Copyright 2010 ABC News Radio


Senate Still Stuck in Food Safety Stalemate

Photo Courtesy - Getty Images(WASHINGTON) -- For 15 months now, a bill to boost the nation’s food safety has been languishing in the U.S. Senate.  The bill would help prevent massive outbreaks of tainted food by giving the Food & Drug Administration the authority to order mandatory recalls and require more frequent inspections of high-risk food processing plants.  But some, like Oklahoma Sen. Tom Coburn, continue to block its passage.

At a hearing on the egg recall on Capitol Hill Wednesday, Senate Majority Leader Harry Reid urged lawmakers to advance the bill with a defined amendment process, saying, “There’s no excuse to wait any longer.  Let’s move this common-sense bill and pass it.”  To do so, Reid needed every lawmaker to agree to his request, including Coburn. But to no one’s surprise, Coburn objected.

“We now have a bill that’s going to cost the American public $1.5 billion over the next five years and it doesn’t fix the real problem – and the real problem is the lack of focus of the agencies to do their job,” Coburn said.

Coburn told Reid he would only agree to move forward with the bill if the $1.5 billion cost was eliminated by offsets written into the bill itself, rather than subjected to specific votes during the amendment process. Coburn also wanted to remove an amendment that would ban the chemical bisphenol A from children’s food and drink containers. Reid said he’d think about it.

Copyright 2010 ABC News Radio

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