Tuesday, January 29, 2008

FDA: broken, like the USPTO?

The New York Times quotes Peter Barton Hutt, a former top lawyer with the FDA who will testify Tuesday before the House Energy and Commerce committee:

“This is a fundamentally broken agency, and it needs to be repaired.”

Does this evoke Jaffe and Lerner or Quillen and Webster describing the USPTO?

The Times also notes: GAO reports and a recent assessment by the FDA’s Science Board conclude that the F.D.A. is so overwhelmed by a flood of imports that it is incapable of protecting the public from unsafe drugs, medical devices and food.

A quote by John Dingell about the FDA sounds eerily similar to complaints about patent quality at the USPTO:

“Our investigation has found ample evidence that F.D.A. inspections across the board are sorely lacking.”

The Times also reported:

An illustration of the agency’s situation comes from a comparison of the allocated budgets of it and the Centers for Disease Control and Prevention. In 1987, the two had nearly identical budgets. Last year, the C.D.C. received nearly four times the amount given to the F.D.A.

In the last 14 years, the drug agency has lost 1,311 employees and nearly $300 million in appropriations to inflation while Congress has passed more than 100 laws defining or expanding its regulatory responsibilities. The agency now regulates about $1 trillion worth of goods, or 25 cents of every dollar spent by consumers.

The agency’s field inspection force has suffered, particularly in the area of food. In 1973, the F.D.A. undertook 34,919 food inspections; in 2006, that number had dropped to 7,783.

As the share of imported food, drugs and devices has soared, the number of agency import inspectors has plunged, to 380 in 2006 from 531 in 2003. Although 80 percent of the nation’s drug supply is now imported, the F.D.A. last year inspected only 30 of more than 3,000 foreign drug plants. It inspected 100 of 190,000 foreign food plants.


The "political" dimension of saying something is "broken" is seen in comments made by candidate Mitt Romney (from

Romney, 60, a former Massachusetts governor, rallied his supporters in Florida last night and took a shot at McCain, without mentioning him by name. "Washington is fundamentally broken, and we're not going to change Washington by sending the same people back just to sit in different chairs,'' he said.


flashback to 2004: "Simply put, FDA and its Center for Drug Evaluation and Research are broken."


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