While Looking For A Commissioner, FDA Makes Organizational Changes And Reviews Regulations

Date: Jul 26, 2001

New Health and Human Services Secretary, Tommy Thompson, may hope to have a new commissioner for the Food and Drug Administration (FDA) named in the near future, but it certainly doesn't look like that's likely to happen anytime soon.

Michael Friedman, vice president of R&D at Pharmacia Corp., had been considered the frontrunner for the job for some time. Friedman held various positions at FDA in the late 1990s, including a stint as acting commissioner.

None of the candidates interviewed so far have made a favorable impression on the Administration. Political difficulties - entailed by issues such as RU-486, stem cell research and human and animal cloning experimentation - may be causing some problems in finding an acceptable candidate to the White House and one who can withstand the confirmation process.

Now that the Democrats have taken over control of the Senate, the new Senate Health Committee Chair, Ted Kennedy (D-MA), will have oversight of the confirmation process and may press for his own candidate. Stay tuned.

FDA makes major changes

In the meantime, the Agency is moving along with other changes.

First, Secretary Thompson plans to examine how the Agency is run, hoping to ease the regulatory process. He has started by reviewing health care regulations, hoping to get rid of those that are considered overly burdensome. He's also asked for industry input and the National Food Processors Association has already recommended eliminating the requirements for food irradiation labeling.

Second, FDA is reorganizing its Office of Premarket Approval (OPA). A new Office of Food Additive Safety (OFAS) will replace OPA. FDA hopes this will improve the efficiency of the review process for food contact materials and direct food additives.

OFAS will consist of three operational divisions, which will report to the Office of the Director: (1) The Div. of Food Contact Substance Notification; (2) The Div. of Petition Review; and (3) The Div. of Biotech and GRAS [generally recognized as safe] Notice Review. A fourth division, Chemistry Research and Environmental Review, is primarily a laboratory research group, but will include FDA's environmental review team.

The current Div. of Health Effects Evaluation, which houses the food agency's toxicologists, will be disbanded. That function will be distributed among the three operational divisions. Each operational division will have its own subdivision for chemistry, toxicology and regulatory matters.

OFAS will also have a policy-making division. Previously this was handled in a less formal manner by a policy board made up of division directors and technical experts necessary to resolve specific problems.

Dr. Alan Rulis, who heads OPA and will be the Director of OFAS, says, "These two major changes present us with the opportunity to dramatically enhance the efficiency and effectiveness of our reviews of each type of application - whether a petition, a notification for a food-contact substance, a generally recognized as safe notice or a biotechnology consultation - while preserving the solid scientific bases for our decisions that is the foundation of the public health protection goals that are essential to our mission."

Used with permission. Copyright FOOD & DRUG PACKAGING, July, 2001.

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