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Ailing
FDA May Need a Major Overhaul, Officials and Groups Say Source of Article: http://www.washingtonpost.com/wp-dyn/content/article/2008/11/25/AR2008112502219.html?hpid=moreheadlines
By Rob Stein
The Obama administration will inherit a Food and Drug Administration widely seen as
struggling to protect Americans from unsafe medication, contaminated food and
a flood of questionable imports from Shaken by a
series of alarming failures, the FDA desperately needs an infusion of strong
leadership, money, technology and personnel -- and perhaps a major
restructuring, say former officials, members of Congress, watchdog groups and
various government reports. "Everywhere
you go, you hear the same chorus: The agency's in trouble," said David
A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general
perception the agency is suffering mightily." With nearly
11,000 employees and an annual budget of more than $2 billion, the FDA is
charged with overseeing products that account for one-quarter of consumer
spending in the United States, including over-the-counter and prescription
medications, heart valves, stents and other medical devices, the blood
supply, and food. But morale
within the FDA, along with its credibility outside, has plummeted as the
agency has been stretched to keep pace with its responsibilities and riven by accusations of ideological bias, a tilt toward
industry rather than consumers, and internal dissension. "FDA is
close to being at a tipping point -- the agency is hanging on by its
fingertips in protecting us," said William K. Hubbard, who worked for
the agency for 27 years. "If something is not done, they could become a
failed institution, and no one wants that. The FDA is not only important to
protecting the public health but also to the industries it regulates." Alarm about
the agency began to spike after a series of highly publicized incidents,
including the discovery that the painkiller Vioxx caused heart
attacks. That has been followed by other safety issues, including questions
about the widely used diabetes medication Avandia and
several psychiatric drugs. "I'm
afraid we're going to see more horrible things happen if we don't get our act
together on this," said David Ross, who was a drug reviewer at the
agency for 10 years. At the same
time, there has been increasing alarm about the agency's ability to protect
the food supply -- concerns highlighted by recent major outbreaks of E.
coli infection in spinach and salmonella in spinach and peppers. That has
prompted calls to split the agency in two -- with one dedicated to drugs and
the other to food. "Food
safety tends to get short shrift," said Christopher Waldrop of the Consumer Federation of America. "The
drug side tends to get much more attention than the food side. Food is
equally important and needs to get the attention it deserves." Both the food
and drug parts of the FDA's responsibilities have been hobbled by its
inability to adequately monitor goods pouring into the United States from
around the world, including food, drugs and raw materials, many say. Such
concerns were highlighted by contaminated toothpaste from "The
agency is still stuck at the border," said Carl R. Nielsen, who was in
charge of the FDA's import operations for the last six of his 28 years at the
agency. "There has to be radical reorganization -- no doubt about
that." Although the
FDA has started opening offices overseas to try to better police safety
standards at the source, experts say much more needs to be done. For
starters, the agency needs to sharply boost inspections abroad, develop
strict new regulatory standards, and update and integrate its computer
systems, which are woefully antiquated and disjointed, Nielsen and others
said. "It's
still largely a paper-driven agency," Nielsen said. "The agency has
great information pigeonholed all over the place, but it cannot be applied in
real time, which is what you need today." The FDA has
also been one of the many federal agencies where Bush administration critics
say ideology has trumped science, citing the long delay in approving the
over-the-counter sale of the emergency contraceptive Plan B. "The
agency needs to get back to using science as the basis for its
decision-making," said Jane E. Henney, who ran
the FDA under Questions have
also been raised about the agency's handling of suspected toxins such as bisphenol A in baby bottles and other products. And
internal dissension has erupted publicly from the usually hermetically sealed
agency. Last week, the House Energy and Commerce Committee released
a letter from FDA scientists complaining about "serious misconduct"
by top managers who oversee medical devices. The turmoil
comes as the FDA is facing a host of new demands, including the next wave of
drugs and other products resulting from breakthroughs in genetics, nanotechnology
and bioengineered foods, among others. And Congress may give the FDA the
power to regulate tobacco for the first time. "This
would be a totally new regulatory responsibility that the FDA doesn't have
expertise in," said Mark B. McClellan, who led the agency in President George W. Bush's first term. While the
agency has received some additional money and personnel to help implement new
drug safety powers, many say it is overdue for a doubling of its budget. "There's
broad bipartisan recognition from consumer groups and from industry that the
FDA needs more resources," McClellan said. "The most important
thing is overall effective leadership that leads in a way that establishes
public trust." Many hope the
new administration will quickly name a new FDA commissioner -- a post that
has frequently been left in the hands of acting commissioners for long
periods. An acting commissioner ran the agency for more than half of the past
eight years. "The FDA
can't be left to drift," said Hubbard, the former official.
"There's a lack of leadership when a caretaker is in charge, and the FDA
can't afford that."
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