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.
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.
posted by Ramsey Baghdadi at 12:54 PM
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