Piling on

As I read more testimony today from the House Energy and Commerce Committee hearing on the FDA today, statistics could not have been more clearly presented about the dire situation the agency faces. Consider the testimony of Peter Barton Hutt, senior counsel at the Washington, D.C. law firm of Covington & Burling LLP and a lecturer on food and drug law at Harvard Law School where I have taught a course on food and drug law. Hutt said:

In the history of our country, no other Federal regulatory agency has ever faced such an onslaught of new statutory mandates without appropriate funding and personnel to implement them. Instead, the agency is expected to implement all of these new unfunded congressional mandates with resources that, in the corresponding time, represent at best a flat budget. Not surprisingly, many of the new congressional mandates languish for years or cannot be implemented at all.

Later...

The science functions within the FDA Center for Food Safety and Applied Nutrition (CFSAN) -- which include dietary supplements and cosmetics -- have been hit especially hard. In the 15 years from 1992 to 2007, CFSAN suffered a reduction in force of 138 people, or 15 percent of its staff. During the same period, Table 1 shows that Congress enacted several important new laws creating major new responsibilities for CFSAN, all of which required substantial scientific expertise for implementation.

The deterioration of the FDA Field Force -- which must daily make scientific evaluations of FDA-regulated products -- has been equally severe. Between 1973 and 2006 there was a 78 percent reduction in food inspections. FDA conducted twice the number of foreign and domestic food establishment inspections in 1973 (34,919) then in did for all FDA-regulated products in 2006 (17,641). The inability of FDA adequately to police the importation of food and drugs into the United States has been well documented by Congress during the past two years.

Later....

Congress must commit to doubling the current FDA funds, together with a 50 percent increase in authorized personnel, within the next two years. From then on, it is essential that the FDA budget at least keep up with inflation and perhaps even more.

TK: What does it mean for the industry? How will Congress find the funds to invest in FDA? While the industry's position is that food safety is a public good and should be shared by all taxpayers, look for more and more pressure to create a steep registration fee or other type of user fees to boost FDA funding and oversight of food safety.