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FDA in Crisis

Drug News--disappointing

Doing as big PHARMA wants—ineffective regulatory review, Congress and the Presidents have reduced the FDA’s ability to regulate the drug industry.  This is free-market economics at work.   



FDA in crisis? Then show them the money



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.



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Those who have a financial interest in the outcome manipulate the results