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100 Days Later, Nation Waits for FDA Overhaul

The FDA is so understaffed it inspects less than 1 percent of imported food.

The Food and Drug Administration may be the only federal agency that both political parties agree is in desperate need of an overhaul.

President Barack Obama is promising action, though progress has been slow in the first 100 days. His choice to head the FDA - Dr. Margaret Hamburg - still has not been confirmed by congress.

Assuming Hamburg is confirmed, she will head an agency whose own Science Board concluded more than two years ago "is at risk of failing to carry out its mandate, leaving our citizens at risk of grievous harm."

Posted in fda, Food/Water

Charting a New Course at the FDA

On March 14, President Obama nominated Margaret Hamburg to become commissioner of the FDA and appointed Joshua Sharfstein, a longtime critic of the pharmaceutical industry, as her principal deputy. Sharfstein, who does not need Senate approval, took over the agency as acting commissioner last week, pending Hamburg's confirmation. His appointment gives real hope that the FDA will stop kowtowing to the big drug companies. For too long the agency has behaved as though its job is to speed brand-name drugs to market, not to ensure that they are safe and effective.

Posted in bigpharma, fda

FOR IMMEDIATE RELEASE
April 2, 2009
2:45 PM

CONTACT: Consumer Federation of America (CFA)
Chris Waldrop 202-797-8551

CFA’s Carol Tucker-Foreman Urges Congress to Modernize Food Safety Laws

Testifies Before House Agriculture Committee

WASHINGTON - April 2 - Carol L. Tucker-Foreman, Distinguished Fellow at Consumer Federation of America’s Food Policy Institute, today told the House Agriculture Committee that the lack of adequate food safety systems has become an emergency the Congress must address by enacting new laws that require the FDA to prevent foodborne illness rather than reacting to it and modernizing the FMIA and PPIA so that the Department of Agriculture can effectively enforce its HACCP and sanitation systems. Both agencies need more research to build science based systems.
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Carol Tucker Foreman is Distinguished Fellow at Consumer Federation of America's Food Policy Institute.
She was Assistant Secretary of Agriculture for Food and Consumer Services, 1977-81. Her responsibilities
included oversight of the nation's meat, poultry and egg inspection and food assistance programs.

Consumer Federation of America is a non-profit association of over 300 organizations, with a combined
membership of over 50 million Americans. CFA's Food Policy Institute was created in 1999 and engages
in research, education and advocacy on food and agricultural policy, agricultural biotechnology, food safety
and nutrition.

Posted in fda, food

FOR IMMEDIATE RELEASE
March 13, 2009
2:30 PM

CONTACT: Public Citizen
Phone: 202-588-1000

Defibrillator Recall Raises More Concerns About FDA’s Competency

Statement of Sidney Wolfe, M.D., Director, Health Research Group at Public Citizen*

WASHINGTON - March 13 - If anyone needed any convincing evidence that there are serious problems with the Food and Drug Administration's (FDA) regulation and approval of medical devices, this week should have erased all doubt. Public Citizen sent a letter today to Acting FDA Commissioner Frank Torti asking why the FDA has not announced the recall of a Welch Allyn automatic external defibrillator (AED), a life-saving device typically used by emergency personnel to resuscitate patients in cardiac arrest.

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Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.
Public Citizen Links:
Posted in fda

Is the FDA a Broken Agency?

A small peanut company's apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients. (The Chronicle, File) WASHINGTON - Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis.

Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

Some say the FDA is broken.

"Bet yourself a new hat or a fine dinner that you are going to have a scandal a month," said Rep. John Dingell, D-Mich. "They are running around like a lot of headless chickens."

Posted in fda

FOR IMMEDIATE RELEASE
March 2, 2009
2:00 PM

CONTACT: Center for Science in the Public Interest (CSPI)
Phone: 202-332-9110

FDA Can't Protect Americans from Dangerous Dietary Supplements, GAO Says

Beleaguered Agency Doesn’t Know Who, or What, It's Regulating

WASHINGTON - March 2 - Add dietary supplements to the growing list of products the beleaguered Food and Drug Administration is failing to regulate.

Today, the Government Accountability Office will report to Congress that the FDA does not have even the most basic information to protect the public from hazardous supplements.

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Since 1971, the Center for Science in the Public Interest has been a strong advocate for nutrition and health, food safety, alcohol policy, and sound science.
Center for Science in the Public Interest (CSPI) Links:
Posted in consumer watch, fda

Late Move on Drugs by Bush FDA Could Be Dangerous

CORNELIUS, N.C. — In the waning days of the Bush administration, the Food and Drug Administration finalized new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly for patients.
Posted in fda, Health, healthcare
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