Will The FDA Reform Bill Make A Difference?
3 CommentsBy Ed Silverman // September 20th, 2007 // 10:09 pm
The Senate approved the legislation, which now goes to President Bush. And the bill addresses - in some fashion - nearly all the controversial issues that have plagued the FDA and the pharmaceutical industry - a clinical trial database, DTC advertising, conflicts of interest on advisory panels, pediatric exclusivity and, of course, safety.
But will the 427-page opus, which you can peruse right here, truly make a difference? Or were there too many compromises on some of the important issues to cause any real change in safety oversight? What do you think? Did Congress get it right?
Will the FDA Reform bill transform drug safety?
- Yes (53%, 44 Votes)
- No (47%, 39 Votes)
Total Voters: 83
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Lisa
Ed,
Its to early for me to vote…
It is my belief that the bill could be watered down significantly by the Senate!!…..We shall see…
Jack
Maybe the bill will change, but I think it will make it through enough to alter practices noticably. Most of these things just make sense.
My take on the changes (not that you asked)…
I think decreasing conflicts of interest on the FDA advisory panels can only lead to good things (but I really have no idea how hard it is to find qualified people without a conflict).
I like that the pediatric exclusivity rules were retained even for blockbuster drugs (Don’t you need pediatric data for popular drugs at least as much?).
I think improved safety monitoring will only make things better. I just hope prescribers keep in mind that no data for older, less well monitored drugs doesn’t mean safe. For example, look at atypical antipsychotics - they carry a black box warning label about increased risk of death in the elderly. Older, conventional antipsychotics don’t carry this warning in their label currently, at least partially because they haven’t been studied as closely and received approval in “simpler” times. However, the data we do have suggests they also carry this risk (Gill 2007, Barak 2007, Schneeweiss 2007, Trifiro 2007, Hollis 2006, Wang 2005), and people started taking these drugs decades ago. So consider that hidden problems with older drugs can exist.
I know people in my company carry concerns about the clinical trial database complicating the logistics of their job (by making it harder to publish in a journal once the results get posted on the website, because of journal policies against duplicate publication). I also read insightful comments from readers of this blog, about how these rules could just cause industry to become even more cautious about which studies it runs and limit data for all. Further, people need to consider adjusting their statistics for multiple comparisons when any researcher can pull the patient data from the database and look for any AE that occured significantly more often in the treated group compared to the untreated group. But I think the database is worth a shot even if it requires significant refinement.
I don’t have an opinion on DTC advertising, except that I think it probably helps society a tiny bit more than it hurts society.
Hank
Clearly, there are some positive things in the new bill. But, beyond the short-term , I do not see it as a positive change. This is because it will be virtually impossible to get further changes any time soon. This was essentialy our one “FDA reform card” to play, and it will hold for some time. After all negative studies on the FDA’s handling of drug safety, including FDA’s own in-house reviews, we needed much more. Once again, Congress failed us.
There is much that could be listed. So here is a minimal set of considerations:
1. The continuation of PDUFA.
2. The minimal consequences of “force and misleading” advertising, even assuming it was enforced. The track record suggests it will not be.
3. The various loopholes re: making public clinical trial databases and results.
4. The continuing subservience of the ODS to the OND.
4. The failed opportunity to make a definitive statement re: preemption. Given the current Supreme Court, the end of civil liability for drug companies - no suits, nowhere, nohow - is a live possibility. This will sound crazy to some folks. See if it still does in a few months.
I’ll stop.