pdf

FDA's New Commissioner Will Focus on Food and Drug Packaging Issues

Date: Dec 02, 2002


President Bush certainly had his troubles finding a commissioner for the Food and Drug Administration (FDA). Since taking the reigns as the country's chief executive officer in January 2001, the President floated several possible nominees for the position, none of which garnered the clear support needed from key Senators to warrant an official nomination.

The process became even more difficult once the Democrats captured control of the U.S. Senate in June 2001 with Senator Jim Jeffords' (I-Vt.) defection from the Republican party. Given the battles that the President expected on many of his judicial nominations (which may now fade with the recent election results), the Administration did not want to expend political capital on filling the post of FDA Commissioner.

So the position sat vacant - until now.

Confirmed by the full Senate in October, Dr. Mark McClellan takes over the reigns of FDA immediately. In doing so, he leaves his post on the President's Council of Economic Advisors and as a senior policy director for health care and related economic issues for the White House. McClellan previously served under the Clinton Administration, as deputy assistant secretary of the Treasury for Economic Policy, where he supervised economic analysis and policy development on a range of domestic policy issues.

Prior to joining the government, McClellan taught both economics and medicine at Stanford University and directed the University's program on Health Outcomes Research. As a researcher, he studied ways of measuring and improving the quality of health care, the economic and policy factors influencing medical treatment decisions, technological change in health care and its consequences for health and medical expenditures, and the relationship between health and economic well-being. He is a two-time recipient of the Arrow Award for outstanding research in health economics.

He holds a medical degree from the Harvard-MIT Div. of Health Sciences and Technology and a Ph.D. in Economics from MIT. He is board certified in internal medicine.

It's hard to question someone with a resume like that and none of the Democrats did.

Attention to packaging issues
In a statement issued by the President in nominating McClellan, it's clear that the White House expects the new Commissioner's emphasis will be on implementation of the recently enacted bioterrorism legislation and on improving the drug review and approval process. However, several issues affecting the food and drug packaging industry will receive attention at the highest levels of FDA as well, including:

    • the use of irradiation for combating biological contamination of food products and how those food products are labeled.


    • several first amendment and truth-in-labeling issues that, although primarily affecting drug products now, will inevitably spill over into the food labeling area.


    • preemption issues as states such as California seek to impose their own labeling requirements on drug products.


    • how dietary supplements are regulated.

Although the new Commissioner may not have much experience on many of these issues, especially those concerning food products, he can rely on his Deputy Commissioner, Lester Crawford, Jr.

Crawford has a medical degree in veterinary medicine and a Ph.D. in pharmacology. He has served as executive director of the Association of American Veterinary Medical Colleges, executive vice president of the National Food Processors Association and most recently as head of Virginia Tech's Center for Food and Nutrition Policy. His government service includes heading the U.S. Department of Agriculture's Food Safety and Inspection Service and FDA's Center for Veterinary Medicine. Crawford's long service in both the food and veterinary medicine fields will serve his new boss well.

Europe also gets a new chief
The European Union is also making some progress in picking a new head for its European Food Safety Authority (EFSA).

Geoffrey Podger, chief executive of the United Kingdom's Food Safety Agency has been nominated to fill the position of Executive Director of the EFSA. The EFSA is Europe's attempt to establish a single agency to be responsible for all food activities, including packaging.

Following the selection of the EFSA management board earlier this year, the appointment of an executive director is the second critical step in making the agency operational. Now only two steps remain: (1) setting up EFSA's scientific committee and panels, and (2) establishing an advisory forum.

With the establishment of a centralized European food safety authority, greater harmonization between the laws of the different nations in Europe will occur and, hopefully after that, harmonization with United States law may become a reasonable possibility.

Used with permission. Copyright FOOD & DRUG PACKAGING, August, 2002.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.