GDUFA? Probably Not This Time

We had an interesting discussion today on the state of the FDA and the impact of the power shift in Washington. Joining me on the conference call, which you can access by clicking here, were biotech PDUFA negotiator Amit Sachdev and former Senate Health Counsel Steve Irizarry.

We touched on way too many issues to discuss here, but one intersting thing to come up was generic drug user fees. The idea of user fees for generic drugs was pushed by senior FDA officials earlier this year. In fact, a senior policy person at the generic drug industry's trade organization - GPhA - just left to join FDA's policy shop to work specifically on generic policy.

But from the sounds of it, generic drug user fees aren't happening for now. It sounds like it could take a while to hammer out. One scenario could have an abbreviated biologics pathway attached to GDUFA legislation at some point down the road, if it doesn't happen in stand-alone legislation proposed by Henry Waxman and co-sponsored by Senator Hillary Clinton.

BIO's Sachdev said that the new Congress gives BIO an "opportunity" to "educate" new members on biologics and the complexities behind the follow-on biologic debate. I think everyone can read between the lines.

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.

Drug Safety Reforms in 2007: Part I

We're just a few days away from Black Tuesday regardless of which Party you're throwing your support behind. While there's a lot at stake for the average citizen, the stakes are tripled for the pharmaceutical and biotech industries.

It now looks all but certain that House leadership will change hands over to Democrats. The Senate looks like a toss-up. If this scenario plays out, there is sure to be drug safety reforms to take place.

Over the course of the next weeks, we'll take a look at some of the changes we think will and won't take place. But let's start with those that won't. The one thing FDA has been dreading is any proposal that calls for splitting up its drug center (CDER) into two premarket and postmarket centers. In its current structure, CDER reviews drugs and approves them as well as monitors them for risks or safety issues once on the market. Some drug safety experts and lawmakers have called for such a reform. Senator Chuck Grassley, who chairs the Senate Finance Committee and is FDA's most vocal Republican critic, made it the centerpiece of his reform legislation co-sponsored by Dem Chris Dodd of Connecticut.

There were rumors that the Institute of Medicine committee on drug safety was thinking about recommending such a measure in their long-awaited report. CDER head Steve Galson called splitting the center up "dangerous." A number of top officials reached out to committee members behind the scenes to lobby against the recommendation.

It worked. The IoM committee left that recommendation out. FDA is breathing a sigh of relief. Not only would it have hurt drug safety efforts (since the drug reviewers are the ones that know the most about a particular drug's risks) it would have severely weakened the position of the CDER director.

The IoM report is serving as the catalyst for any changes that take place as a part of the drug safety debate on Capitol Hill. In other words, in order for it to happen on the Hill, it probably has to be in the IoM report.

In FDA's view, the agency dodged a bullet.

Next: We'll look at the drug safety impact on the individual reviewer.