Is The FDA A Broken Agency?

By: By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
By: By RICARDO ALONSO-ZALDIVAR and MIKE BAKER

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

Every few months, the Food and Drug Administration goes into
fire-brigade mode, rushing to get control over another safety
crisis. The agency that regulates products worth 25 cents of every
dollar spent by U.S. consumers seems overwhelmed by its own
mission.

Some say the FDA is broken, and others want to break it up - by
moving food safety to a new office.

"You've got an agency that quite frankly is either
non-functional, or dysfunctional, or maybe all of the above," said
Rep. John Dingell, D-Mich., who as the longest serving member in
the House, has investigated many agencies, including the FDA.

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

Others, even some critics, see tentative improvements. Many
defenders acknowledge the FDA is struggling.

"'Broken' is the kind of word that's sort of a fighting word,"
said Dr. Frank Torti, the cancer researcher serving as acting FDA
commissioner. "We have recognized for a long time that more is
needed. Because of a lack of (legal) authorities and inadequate
resources, it's really hard to do the job."

Restoring the FDA's reputation will be a major challenge for an
Obama administration that strode into town promising competent
government.

The decline didn't happen overnight. There's no single, simple
cause. In 2007, an independent group of science advisers concluded
that the FDA was in danger of failing in its mission. "American
lives are at risk," said their report. It wasn't the first alarm.

As the pharmaceutical and food industries went global in recent
years, the FDA fell behind on inspections. Its legal powers failed
to keep up with fast-changing industries. Its own scientists said
it grew too cozy with drug companies and tuned out signals of
safety problems.

Money for research grew scarce. The agency struggled to answer
such seemingly simple questions as how far from a cow pasture a
farmer should plant his spinach patch to keep out bad germs.
Internal computer systems were allowed to decay, although they are
essential to monitoring drug safety trends or blocking shady
imports.

The FDA drifted. During the Bush administration, it went long
periods without a permanent commissioner who could be an advocate
before Congress. Lawmakers piled new responsibilities on the
agency, often without the funds to carry them out.

This past year's safety problems - homegrown and imported -
illustrate the FDA's weakness.

Last winter, heparin from China contaminated by a mysterious
ingredient prompted an international recall. The blood thinner,
used to treat people during heart surgery and kidney dialysis, was
triggering life-threatening allergic reactions.

Summer brought a salmonella outbreak blamed first on tomatoes,
and later on hot peppers as well.

This winter, it was salmonella again, in peanut products. A
small company's apparent disregard for basic sanitation led to the
recall of more than 2,800 foods that used its ingredients.

More than 2,100 people were sickened in these incidents. At
least nine deaths have been blamed on tainted peanuts alone.

Last week, another problem surfaced. Federal prosecutors in
North Carolina obtained guilty pleas from two employees of AM2PAT,
a company that manufactured syringes in unsterile conditions and
covered it up with phony paperwork.

Prosecutors say hundreds of patients were sickened and five
died. The FBI is looking for the company's owner, who may have fled
the country.

Different products were involved in the incidents, but some of
the same FDA shortcomings: inspections, legal authority and
technology.

The pharmaceutical plant in China that made the heparin was
never inspected by the FDA, partly because the agency confused its
name with a similar name belonging to another factory. It was
unclear how many foreign drug facilities fall under the FDA's
jurisdiction because one government database lists about 7,000 and
another, 3,000.

Sending inspectors to China used to involve first waiting for
permission from the Chinese government. The situation has improved,
under a U.S.-China agreement that led to the opening of FDA offices
there.

The tomato outbreak last summer underscored other kinds of gaps.
Produce companies are not required to have a food safety plan. And
the FDA lacks legal authority to require a system for tracing foods
back to the farm. Investigators had to sift through piles of paper
records as losses mounted for tomato growers. Dingell said the FDA
looked like the Keystone Kops.

In the peanut butter outbreak, the FDA has been slowed because
of the length of time it takes to identify positively a strain of
salmonella. The agency wants to replace current lab tests that can
take a week or more with technology that cuts the wait to a day or
two.

FDA inspectors quickly descended on the small Georgia facility
at the center of the peanut outbreak. But they didn't get the whole
story immediately. The FDA had to invoke bioterror laws to get lab
reports that ultimately showed the company shipped tainted peanuts.
Meantime, the agency had no authority to order a food recall.

"The FDA has been trying to do so much with so little for so
long that they really have lost the vision of what would make an
effective food safety program," said Caroline Smith DeWaal, food
safety director for the Center for Science in the Public Interest,
which wants to set up a separate food agency.

Congress has been pumping more money into the FDA the last
couple of years. And the Obama administration seems willing to
consider big changes, especially on food safety.

The two leading candidates for FDA commissioner are physicians
from outside the agency. One is Baltimore health commissioner
Joshua Sharfstein, a pediatrician who has taken on the FDA over
risks in children's cough and cold drugs. The other is Margaret
Hamburg, a bioterrorism expert who served in the Clinton
administration and as New York's health commissioner.

"One area where we could see bipartisan cooperation might be
the strengthening of the FDA," said Dr. Paul Stolley, a former
department head at the University of Maryland medical center who
had a stint as a visiting scientist at the FDA. "I don't think
ideological differences should interfere."
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Baker reported from Raleigh, N.C.
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On the Net:
FDA Science Board report - http://tinyurl.com/yvnk28


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