A Clean Sweep: The End of an Era At FDA?

Wow. Everyone was expecting the Democrats to take the House, but the Senate too? That was a real long shot considering the entrenched incumbents up for reelection. Washington is reeling from the total shift in the balance of power and the overnight change in leadership.

So where does that leave FDA?

For the FDA, 2006 may be remembered as the end of the pro-innovation and pro-industry era at the agency. Since Mark McClellan was put in place, FDA has been as friendly as ever with drug companies and biotechs. Friendly, not cozy. In other words, McClellan, Crawford and now von Eschenbach have created an atmosphere of openness, transparency and communication. Senior officials have made it a point of speaking openly with Wall Street and the media about policy, to provide some predictability. You can argue whether that's good or bad.

But the FDA will be monitored more closely than ever. Some analysts and pundits are saying the Dems will tread lightly despite all of their accusations of corruption and coziness. That will be true in some areas. But FDA and drug companies do not fall in those areas. There is bi-partisan agreement that drug safety reforms are a priority. It's the so-called "low hanging fruit" that House and Senate Dems in leadership positions will go after.

The individual drug reviewer now has a "very friendly" Congress at their disposal if they think a regulatory decision on a particular drug or policy is being forced down their throats. You can count on that. Before November 7, they had Charles Grassley and Ted Kennedy. Now they have the entire House and Senate.