Is FDA Rudderless in Today's Turbulent Seas?

Date: Dec 01, 2005

To say that the Food and Drug Administration has had a rocky past year or so is definitely an understatement. The Agency has been castigated for how it has reviewed and approved certain types of drugs, how it has conducted post-market surveillance for others and for failing to approve new drugs quickly enough.

Now, the most recent, permanent commissioner of FDA has resigned after only a few short months in office. Naturally, people are asking whether FDA can do its job without a leader at the helm (some in Congress were asking whether it can even do its job with a leader).

For whatever reason, FDA has been without a permanent commissioner for most of the five years that the Bush Administration has been in office. Whether it is a matter of priority, political concerns or a combination of the two is not quite clear. It took almost two years before the White House got its first commissioner in office, Dr. Mark McClellan, and then he stayed in the job for only 18 months.

Dr. Lester Crawford, who had been serving as Deputy Commissioner since early 2002, was then named acting commissioner when McClellan left in mid-2004. Unfortunately, things stayed that way for sometime until Crawford was nominated to take over the job permanently in February of 2005.

After a bruising confirmation battle, in which a vote on his nomination was threatened to be held hostage by a couple of senators over FDA's plans to consider making an emergency contraceptive known as Plan B available without a prescription, Crawford was finally sworn into the post in mid-July of this year, only to suddenly and unexpectedly resign two months later.

Why Crawford resigned remains a mystery to some. Much of the speculation suggested that it had something to do with omitting disclosure of some financial holdings in companies regulated by FDA. Most likely the explanation might be the one suggested by Crawford immediately upon resigning: That he didnt think he was "up to it" anymore - that is, another year of 20-hour days, the attacks on his integrity and professionalism, and the constant political controversy that swirled around so many decisions in which FDA was involved.

Now, FDA is back to having an interim chief; this time, Andrew von Eschenbach, the director of the National Cancer Institute. Dr. von Eschenbach is a nationally recognized urologic surgeon who formerly directed the Genitourinary Cancer Center and the Prostate Cancer Research Program at The University of Texas M.D. Anderson Cancer Center.

In the meantime, FDA is humming right along. Even without a permanent commissioner, the agency continues to move forward in approving products and implementing regulatory programs in each of its centers.

How does all the work get done? For one thing, FDA long ago instituted a management system in which each of its main centers (drugs, biologics, food and devices) has primary responsibility for the products it regulates. Although direction may come from the top, day-to-day activities are the responsibility of the heads of each center and their staff. These people, of course, are trained and dedicated professionals who do their job regardless of who is president, who is commissioner or which direction the current political winds might be blowing.

Except when it gets involved in lightening rod issues like tobacco regulation and "morning after" pills, the agency has an amazingly good record of making decisions based only on the science presented; something which is to the benefit of us all. Thanks to the dedicated and professional staff at FDA, the U.S. supply of foods, drugs and other products that fall under the agency's purview are some of the most secure in the world.

Used with permission. Copyright FOOD & DRUG PACKAGING, December, 2005.

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