A Step in the Right Direction?

By Mike Scott

On November 14, 2002, Mark McClellan was appointed Commissioner of the U.S. Food and Drug Administration and held the position for 14 months. Lester Crawford was confirmed to replace Dr. McClellan on July 18, 2005, and held the office for just 2 months. Indeed, since David Kessler stepped down in February 1997 there has been a confirmed Commissioner of the FDA for less than 4 of the following 9 and a half years. This is not a track record to cheer about. And the stature of the FDA has suffered badly as a consequence.

No one who works in the U.S. biotechnology or pharmaceutical industries can be in much doubt today about the range of challenges facing any individual who holds the office of Commissioner. Not only did Dr. Kessler set a new standard for activism as a holder of this office, but the increasing attempts to influence the decisions of the FDA through political, legal, social, commercial, and other channels has made this position one of the most visible and perhaps unenviable public positions in modern US government. Indeed, the Commissioner commonly has greater name recognition than his or her superiors in the Department of Health and Human Services.

If one puts aside personal political views and accepts that the FDA "adheres to [four] fundamental principles that frame its actions and lead to more effective public health results," as stated on its Web site [1], it should be noted that the current Acting Commissioner, Andrew von Eschenbach, has made a strong start in seeking to fill the shoes of some of his more successful predecessors.

Dr. von Eschenbach has moved quickly to address one of the most difficult situations outstanding at the FDA: Barr Laboratories' application for approval of Plan B as an over-the-counter agent for the prevention of pregnancy. It may be that without such action, his ability to gain Congressional approval for his appointment would have proved impossible. It may be that, as a friend of the Bush family, he was able to persuade the Administration in the White House that such action was a political imperative.

One can think of a lot of such, "It may be's." The facts, however, speak volumes about Dr. von Eschenbach's apparent desire to make it clear that, under his leadership, the FDA will seek to be judged on the scientific validity of its decision-making process, even if a little compromise is necessary along the way.

The signs are now strong that Barr Laboratories will gain an approval to market Plan B as an over-the-counter agent available to any woman of 18 years or older. Women under the age of 18 will continue to require a prescription for this drug. Some may claim that this is still a "political" decision and that the FDA should have approved the availability of this agent for younger women as an OTC agent, as originally recommended by an FDA Advisory Committee. And of course such an approval will be a political decision but it would be a good political decision at a time when this nation is torn by strongly held emotional and religious beliefs not only about when life begins but also about when and how life can end. Plan B should become widely available to adults and younger persons will be required to seek some professional guidance associated with the product's use.

The pharmaceutical and biotechnology industries must take a strong stand alongside Dr Eschenbach in support of this decision. The nation is in desperate need of an individual who can and will bring real leadership to the FDA, and who can be relied on to place a premium on the importance of sound science as the imperative that will guide FDA decision-making for the foreseeable future. Small compromises may be necessary on occasion for all sorts of reasons, but good scientific evidence as the fundamental basis for action is the principle that will best benefit the American public and FDA-regulated industries.

Few of us will agree with every decision that Dr. von Eschenbach makes if he is confirmed as Commissioner, but most of us should agree that a strong Commissioner who takes decisive action is essential.

Mike Scott is a principal and executive vice president of Vox Medica, Inc., a Philadelphia-based group of healthcare communications companies.