New FDA chiefs stress science, better food safety

May 26, 2009 By LAURAN NEERGAARD , AP Medical Writer

(AP) -- The huge salmonella outbreak from peanut butter represented a failure of the Food and Drug Administration, that agency's new chiefs declared Tuesday - one they hope to fix.

Expect a "modern food-safety system focused on prevention of contamination," FDA Commissioner Margaret Hamburg and her deputy, Joshua Sharfstein, wrote in The .

Even its defenders acknowledge the FDA - the nation's chief consumer protection agency - is struggling, given increasing responsibilities overseeing ever-more-complex health industries, but not a budget sufficient to do the job. An independent review in 2007 concluded lives were at risk, and morale plummeted as the agency's own scientists charged their safety concerns were dismissed by leaders too cozy with industry.

Hamburg, who was just sworn in on Friday, and Sharfstein have pledged to restore the FDA's credibility. The two physicians introduced themselves to the country's doctors Tuesday in an article published online by the respected medical journal - and they didn't underestimate the work ahead.

One priority: Working with the Agriculture Department to improve food safety, following some high-profile crises including the outbreak earlier this year that sickened nearly 700 people and is blamed for at least nine deaths. Peanut Corp. of America is under for allegedly shipping peanut butter and another ingredient used in thousands of other products that it knew to be tainted.

That outbreak "represented far more than a problem at one troubled facility. It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls," the duo wrote. "And it exposed the failures of scores of to adequately monitor the safety of ingredients purchased from this facility."

The FDA's success shouldn't be judged by how many factories it inspects or drugs it approves, but in its overall work to improve public health, the pair wrote. For example, FDA scientists are working behind the scenes to grow the new swine-flu virus and make the ingredients necessary to test if vaccines against it are potent enough, and eventually will oversee vaccine production quality.

"The agency's success will be determined by the nation's access to a safe and effective vaccine," the pair wrote.

And while "the FDA must make difficult decisions in the absence of ideal information," they acknowledged that recent controversies were "opening the door to legitimate questions from the media, the public and Congress about whether the public interest is being served."

To help get back on track, the new bosses promised "a culture that encourages scientific exchange" and to better explain the science behind their decisions to the public.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: Simulation-based training improves endoscopy execution

add to favorites email to friend print save as pdf

Related Stories

Drug industry advocates join chorus to split FDA

Mar 22, 2009

(AP) -- As momentum builds to rework the nation's food-safety system after a salmonella outbreak linked to peanuts, the drug industry is hoping for a happy side effect: faster approvals for new medicines.

Obama focuses on food safety, picks FDA new chief

Mar 14, 2009

(AP) -- The nation's food safety system is a "hazard to public health" and overdue for an overhaul, President Barack Obama said Saturday as he filled the top job at the Food and Drug Administration.

Salmonella outbreak: What you need to know

Feb 02, 2009

Consumers must remain vigilant about tossing salmonella-tainted peanut products found during a recent outbreak, food safety experts said. A few more people get sick every week. More than 400 products have been recalled, and ...

Recommended for you

Using feminist theory to understand male rape

2 hours ago

Decades of feminist research have framed rape and sexual assault as a 'women's issue', leaving little room for the experiences of male victims. But a new study published in the Journal of Gender Studies suggests that feminist ...

Simulation-based training improves endoscopy execution

Oct 18, 2014

(HealthDay)—Simulation-based training (SBT) improves clinicians' performance of gastrointestinal endoscopy in both test settings and clinical practice, according to research published in the October issue ...

Data sharing in pharmaceutical industry shows progress

Oct 16, 2014

To enhance the transparency of clinical trials for new drugs, a number of pharmaceutical firms have begun sharing data with investigators outside their own companies. Brian L. Strom, chancellor of Rutgers Biomedical and Health ...

Swiss drug maker Roche posts flat 3Q sales

Oct 16, 2014

(AP)—Swiss drugmaker Roche Holding AG has reported "stable" or flat sales for the first nine months of 2013 but says the results show strong demand for its cancer drugs and emerging new products.

User comments : 0