Federal Pre-Emption Has a Place, but Maybe Not This One

Jay Lefkowitz and Michael Shumsky (“Obama Embraces the ‘Pre-Emption’ Doctrine,” op-ed, Sept. 14) make some valid arguments applicable to legal trade-offs between states’ product-liability laws and the Food and Drug Administration’s labeling regulations. However, they are off-base in describing the FDA as “cash-strapped.” The FDA’s spending on the regulation of human drugs in 2009 was $802 million, and the president’s 2011 budget demands $1 billion, an increase of 20% over two years. The number of personnel conducting drug reviews has doubled from 1,300 to 2,600 between 1992 and 2007. The agency as a whole exceeded its hiring targets last year.

This money and manpower, unfortunately, have not increased the FDA’s productivity—for which patients pay the price. My recent review concluded that even a one-year delay in legal access to the many new medicines available costs about 200,000 American patients their lives annually.

The FDA is not a cash-strapped crusader for public health, but a bloated government bureaucracy that interferes with the choices of doctors and patients alike.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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