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Just How Seaworthy is the USS FDA?

June 18, 2010


This week the Alliance met with Michael Taylor, FDA Deputy Commissioner for Foods.

Upcoming Meetings

  • Week of June 28: Karen Midthun, Director of Center for Biologics Evaluation and Research (CBER).


If FDA were a ship, we would be discussing how the boat has taken on too much cargo. Without some relief, the ship is at risk of springing a leak … and might even sink. Unfortunately, there is no prospect of relief — there is little that can be off-loaded and additional cargo is already piling up on the docks. The ship’s owner has already said there will be very little money available to rebuild the ship or put an additional ship into service.

I use this metaphor because I see some bulges in the hull of the FDA ship. I have started to wonder when there will be leaks and whether they will threaten the viability of the entire ship.

Here are some things I have spotted:

  • The tobacco legislation was signed into law a year ago and the FDA program is growing rapidly to meet the requirements of the new Act. Every penny is coming from user fees on tobacco companies, which will be about $450M under the President’s FY 11 budget request. Nonetheless, OMB is counting this money as part of the agency’s growth. It is as if they sent another boat to assist the FDA, but neglected to mention that it can take only tobacco cargo and doesn’t help with anything piling up on the docks. Despite the rhetoric, there is no relief from this effort.
  • Congress is considering food safety legislation. By the fifth year after it passes, the amount of food cargo will have doubled (House CBO score) with no assurance there will be monies to rebuild the ship or commission an additional one. The prospect for passage of the legislation is uncertain, but no one is discussing how much additional food cargo will pile onto the docks regardless. The IOM report on food safety is the most recent (of many) that point out how much work is needed. FDA can’t handle this cargo without more capacity.
  • The IOM report was also the most recent to focus on deficiencies in information technology aboard the FDA ship. Eventually, an investment in new databases and speedier communications may allow us to put more cargo on the ship, but it will require a lot of upfront investment before anyone will be able to see the improvements.  
  • FDA has said it wants to be more involved in reviewing the operational aspects of clinical trials before studies are started. Having dealt with a few studies (after the fact) that were carried out poorly, I consider this change of policy to be very pro-innovation. However, with all of the drug/biologics cargo already sitting on the dock, it is hard to know how FDA can handle this initiative without a bigger ship.

I wish this was a complete list, but it is just the observations made over a few days. Do you agree that FDA is at risk of springing leaks or even sinking? I encourage you to send me the examples you see — where the risk of overload and failure have become quite high. I will report some of the best ones here and we will try to incorporate some of them into Alliance materials and presentations.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.


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