A public health crisis either exists or it doesn't. But political opportunities are created. And whenever possible, they are bankrolled for use when the need to make political gains is especially urgent.

In this case, one could have predicted that the Clinton administration and the FDA were going to play the tobacco card, the only question was when. The set up has been going on for months, and only a deaf, blind person could have possibly not anticipated its coming last week.

While the tobacco issue may seem remote to the biotech community, it serves as a powerful reminder. Regardless of what soothing noises you hear from the agency about clarifying its regulatory role, disavowals about intimidation and vengeance against its industry critics, and its willingness to engage in FDA reform "lite", at the end of the day, the FDA is about the expansion of government power and lack of accountability.