Who Will be Commissioner?Although considerable support in segments of the regulated industry to keep FDA Commissioner Jane Henney is likely, that seems a longshot. Generally viewed as having done a capable, if unspectacular job, Henney has been accessible and open-minded, and continuation of her tenure would bring continuity and stability to the FDA.
Henney faces two serious problems. Republicans will want to take advantage of every available position to appoint their own people. Moreover, Henney is anathema to the conservative right because of her role in approving the abortion pill, RU-486. This last problem may be fatal to Henney's chances of keeping her job.
The credibility of FDA's food regulatory programs could be at risk if Bush's commissioner nominee does not understand the critical role of regulation in ensuring consumer confidence in the safety of the food supply.
Single Food Agency?There is a risk that George Bush could find a pathway to a single food agency, though its strongest supporters are consumer groups.
Most major food industry trade associations, with the exception of FMI, oppose a single food agency. The position of these groups is well-founded, as no persuasive evidence supports the proposition that combining food safety functions currently in different agencies into one "all powerful" food regulator would bring a better food regulatory regime. Problems with the current regulatory regime have to do with allocating resources between various regulatory agencies and the shortfall in resources devoted to FDA's regulatory programs.
Do not be surprised, however, if a "single food agency" bill gets an early introduction in Congress and some serious consideration.
FDA ResourcesFDA's resources devoted to food programs have steadily declined over the last two decades. Failure to reverse this is the biggest challenge facing FDA food regulators and policymakers. Food companies should understand the challenge, and overcoming it should garner their support.
Inadequate resources for food programs puts FDA's food programs at risk of losing consumer confidence and worldwide respect. The regime arising after a loss of consumer confidence is likely to be less hospitable to the interests of food companies than that which occurs if the crisis is avoided.
What areas of FDA's food programs are most in need of attention?
Research and Risk Assessment: Lack of resources makes it increasingly difficult for FDA to keep current in areas as diverse as microbiological, chemical and pesticide risks. Its knowledge base on nutrition and biotech issues is also imperiled, and CFSAN does not have a single food allergist on staff.
Petition Review/Pre-market Approval: FDA has made significant progress in improving reviews of applications to market new food ingredients. Without additional resources, it is doubtful that much more progress can be made.
Foodborne Illness Surveillance: Program activities intended to inform regulators in a timely way of developing problems in food-related illness are critical to ensuring food safety.
Standards: The current regulatory system relies on FDA providing timely and sensible guidance to the regulated industry--in the form of guidance documents, compliance policy guides and even, on occasion, regulations. Even with a priority system, CFSAN is well short of the resources needed to keep pace with the need for timely guidance.
International Presence: FDA's involvement in various international organizations and trade issues is of increasing importance to the regulated industry. A full-time FDA presence in Europe is probably warranted, as are sufficient resources to have personnel at important international meetings while retaining a viable presence at home.
Risk Communication: FDA must be more knowledgeable about risk communication and better able to put risks in perspective.
Imports: FDA currently samples and inspects about 1% of food products offered for import into the United States. Resources are needed for the FDA to develop creative, innovative programs that help to ensure imported food products meet U.S. standards.
Domestic Inspections: The frequency (or infrequency) of domestic inspections has been used effectively by consumer groups to argue that the current food safety regulatory regime is a joke. The frequency of inspections has declined dramatically over the last two decades. FDA will need additional resources to employ a sound, risk-based paradigm for plant inspections.
Nutrition: At one time, FDA's personnel and knowledge base in nutrition was unmatched. A substantial decline in personnel with an increase in responsibility and complexity of issues has stretched this area of CFSAN responsibility way too thin.
Facilities: Modern labs and technology are important to an efficient FDA. Premarket approval applications should be submitted and reviewed electronically, and FDA should have the resources to conduct sample analyses as rapidly as current methods permit.
This ambitious list of resource needs should not be viewed as a "one-year" project. Rather, addressing these will require a dedicated commitment over the next five to seven years. FDA progress with the new president will depend on the extent to which the regulated industry comes to understand and appreciate how its success is dependent on an effective and well-funded CFSAN. Without that support from industry, it is doubtful that the decline in the financial support of FDA's food programs will be reversed.