Pony up, Congress. Stop whipping the FDA for its failures and fork over the cash necessary to fix the problem. That's what editorial writers at the Boston
Globe and New York Times said over the weekend. "Congress should boost FDA spending to whatever level it takes to restore public trust in the agency," the Globe contended.
We all know the stats by now: Though 80 percent of drugs sold in the U.S. are made overseas, the number of import inspectors has dropped by
a third, and only a handful of the thousands of foreign manufacturing plants are inspected each year. The FDA's
$2 billion budget has dropped by $400 million in inflation-adjusted dollars over the last 14 years. Meanwhile, more than 100
statutes over the last 20 years have handed the agency new duties. As the Times points out, informed observers are nearly unanimous: the FDA is in
crisis. Even Congressional Democrats and Republicans agree on this point.
The Bush administration has shown little appetite for the major increase
in funding the FDA needs. Recently, it established a working group on the safety of imports but it stipulated that any reform
proposals should be "within available resources.""The FDA desperately needs an infusion of
money and talent," notes the Times. In another
editorial--linked to coverage of a Chinese company that distributed tainted cancer drugs, paralyzing hundreds--the paper calls
on Congress and the White House to "move quickly" to strengthen the FDA. We'll see if the government takes heed.
Oh, woe is the FDA. The Government Accountability Office is set to release a new report
on the agency's terrifically inadequate inspection record overseas. According to the New York Times, which obtained a copy early,
the FDA is so understaffed that it would need at
least 27 years to inspect every foreign medical device plant and 13 years to check every foreign drug plant. Think that's
bad? Catching up on food inspections would take a mind-boggling 1,900 years. The attrition in personnel has been especially acute among inspectors of the exploding market in imported goods. While
80 percent of all drugs sold in the United States are made overseas, the number of import inspectors has plummeted, from 531
in 2003 to 380 in 2006. In 2007, the FDA inspected just 30 of several thousand foreign drug-making plants. It inspected just
100 of 190,000 foreign food plantsc
Most disturbing is the fact that the agency is farthest behind in--you guessed it--China,
that bastion of impure and unsafe exports. China has more drug and device plants than any other foreign nation, and FDA inspections
there are few, the Times notes.
Those resources are so insufficient
that a former associate commissioner of the FDA, William Hubbard, told the Globe last year that the FDA checked just 2 percent
of all food imports from China, a country with a record of shipping food contaminated by carcinogens, filth, and pesticides.
Congress should boost FDA spending to whatever level it takes to restore public trust in the agency. Right now, it is failing
in its mission to protect buyers of food and medicines.
The GAO will present this bad news at a hearing before the House Energy and Commerce Committee,
which has been dogging the FDA for months now. One witness set to testify said, "This is a fundamentally broken agency, and
it needs to be repaired." We advise the FDA to focus on the "repair" part of that sentence. Today will be painful, sure, but
it could lead to a sorely needed increase in funding. If the stars and politicians line up just right, that is.