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.