Consequences of Politicization

Former FDA deputy commissioner for policy Michael Taylor explains the reasons behind what he sees as an increasing politicization of FDA regulatory activities. His remarks are from a presentation at the Food & Drug Law Institute annual meeting April 6.

"When I first received a political appointment to be executive assistant to the commissioner under then-President Carter, I was an apolitical staff lawyer at the time, and had to remind my boss, Jere Goyan, who was commissioner, that he should alert the [HHS] Secretary’s office to the fact that he was giving me the job. There was no political or White House scrutiny of the appointment, and during my tenure in that job, I never was required to attend a White House meeting on FDA business.

Fast-forward 11 years to my appointment as deputy commissioner for policy in 1991 under the first President Bush. This appointment required the serious marshalling of political support, and during my tenure in that job, which continued into the Clinton Administration, I spent a great deal of time fending off external pressures to shape rules on grounds that fell outside what we considered to be our statutory and public health charge. Sometimes, [I was] making more than one trip a day to the White House on FDA business.

One thing that happened during this period which I think contributed to politicization was the enactment in 1988 of legislation that made the commissioner subject to Senate confirmation. Commissioner David Kessler, for whom I worked, was the first commissioner to go through this inherently and intensely political process.

In addition, throughout this period, Congress passed and FDA was charged with implementing a series of new laws on hot topics that put FDA in the political spotlight. This included—and this is just to name a few—the Nutritional Labeling & Education Act, the Prescription Drug User Fee Act, the Dietary Supplement Health & Education Act, and the FDA Modernization Act.

FDA is certainly not alone in this modern era in the trend of Congress legislating in great detail on contentious topics that direct executive agencies on what they are supposed to do and how they are to do it. That, in fact, is the prerogative of the Congress…and I would say much good has come from this legislation.

But look where we are today, in the much more political climate surrounding FDA. In the period since Dr. Kessler left office, we’ve had an acting commissioner over 60% of the time. I attribute this largely to the politics of the appointment and confirmation process."