Taking the F out of FDA….

Twice with in the past week, the New York Times has carried an article referencing the desire among some to split the Food and Drug Administration into two parts, one that oversees food and one that oversees drugs. 

On March 12 in an article written by Gardiner Harris about the appointment of Margaret Hamburg to be the next Food and Drug Administration Commissioner, there was speculation made that the reason she and Dr. Joshua Sharfstein were being chosen as Commissioner and a Deputy Commissioner respectively was so that one could take over food and one could take over drugs in separate agencies.  That seems a highly unlikely prospect, at best, but stranger things have happened.  

The second instance was in an article written by the same reporter published on March 14 – President Plans Team to Overhaul Food Safety.  The article reflected the President's Weekly Address that was devoted to food safety and in which he stated that he was developing Food Safety Working Group that will include the Secretary of Health and Human Services as well as the Secretary of Agriculture who will advise the President on what laws and regulations need to be changed to bolster food safety.  Inevitably, the key focus will be whether to add resources to the FDA's oversight or to give food to another agency, possibly a new one. 

There is no question that the concept of food safety has been challenged over the past few years.  While on the drug side, the FDA has been greatly criticized on Capitol Hill by a number of members on both sides of the aisle, the agency has also managed to develop a following of detractors on the food side as well.  And, in fact, reform legislation has been introduced by some of those critics, such as HR 875 – the Food Safety Modernization Act of 2009 by Congresswoman Rosa DeLauro.

But it is important to remember that the nature of our food commerce has changed dramatically in this country since the 1990s.  As a nation, we developed a taste not only for fresh fruits and vegetables year round, but fish as well, and we got much more exotic in our tastes so that a fruit like kiwi is not available year round in gourmet stores, but also in small, regular grocery stores.  What was unusual to get in the 1980s (starfruit, e.g.) is now commonplace.  That was an example of where demand coincided with globalization that provided the means to deliver.

The ability to meet the growing demand of regulation that would necessarily accompany such an explosion in range and depth of food sources was not supplied to the FDA.  In the 1990s to meet the growing demand for prescription drug oversight, the Congress enacted PDUFA – the Presription Drug User Fee Act which supplied user fees for the drug side of the equation to grow enormously and to hire more employees so that drug approval times could be sped up – becauase there was also a growing demand for faster access to drugs, made all the more urgent by a burgeoning HIV epidemic.  But there were no user fees for food.  There is no FPUFA (Food Producer User Fee Act).  There were no resources for the growth of food.

No doubt about it, there is a lot to be desired in the way our food is overseen.  For example, regulatory oversight of beef and chicken is at USDA, but the clean production of vegetables is at FDA, and even some meat such as ostrich, venison and snakemeat are with the FDA.  

But the idea of taking the F out of FDA and putting all food with the USDA or with a new food agency is not as simple, nor necessarily as desireable, as it sounds.  It would be very expensive for one thing, and there is no true insight that the current system is not working well because it is primarily with the FDA, nor any evidence that putting it under one roof will automatically lead to an improved status.  

And in the end, there are two significant truths here – First, the shift to a new agency or new structure will not, in an of itself, make food safe. And second, no matter what we do, it will be absolutely impossible to make food 100% safe and our risk averse natures, so strong these days, will never be satisfied with anything less. 

Here is the President's Weekly Vid Address where he mentions his appointment of Dr. Hamburg and outlines his food safety overhaul plans.