'Good' vs. 'Perfect' By Steve Usdin
Contributing Editor

WASHINGTON - Whatever the outcome of the GOP's effort to implement its Contract with America, FDA reform will be among the mass of more complex issues that will filter onto Capitol Hill agendas after the first 100 days of the 104th session. Some members of Congress and a variety of trade associations, think tanks and companies are preparing for a spring FDA reform campaign.

The current atmosphere in Washington, created by a reform-minded Congress and an administration scrambling to "reinvent" itself, presents good opportunities for regulatory and statutory changes.

Industry groups representing the biotechnology, pharmaceutical and medical devices industries are mobilizing to take advantage of the changed climate in Washington to pursue regulatory and legislative reforms. Although detailed action plans still are being developed, the broad outlines of the coming campaign are discernable.

In some respects, it will be a war in which the advocates of "good" - detailed, incremental changes aimed at removing impediments to biotech products - compete against the apostles of "perfect" - elimination of the FDA or a radical reassessment of its role.

However, the resulting clamor for change carries unforseen risk, according to Biotechnology Industry Organization President Carl Feldbaum, who warns that the atmosphere could become overheated, resulting in a meltdown of reform efforts.

Unlike industry's battle against price controls in the health care reform debate, the biotech industry's objectives are complex, impossible to convey in a sound bite, and for the most part best pursued discretely, behind closed doors, according to Feldbaum.

Not like last year

"This is not like health care reform. The political situation is much more complex with regard to the FDA. There is not a single issue, such as price controls. It must be borne in mind