House And Senate Agree On FDA Reform
8 CommentsBy Ed Silverman // September 19th, 2007 // 2:47 pm
The legislation passed the House by a wide margin - 405 to 7. The Senate is expected to vote later or tomorrow. There is much to study in this document, but you can read the bill yourself right here. These are a few highlights we have gleaned from our reading so far…
- Clinical Trial Results: Drugmakers will be required to place technical summaries on the Internet within a year. And lay summaries may be made available in three years if the FDA can develop rules to ensure these aren’t promotional or misleading;
- Preemption: The Senate version included preemption, which would have provided drugmakers with immunity from product-liability lawsuits in state courts, but the language doesn’t seem to appear here;
- Conflicts of Interest: Over five years, the number of FDA advisory panel members with conflicts of interests will be reduced by 25 percent. This falls short of the complete ban FDA critics sought, given that waivers are offered regularly;
- DTC Ads: The FDA will be able to make drugmakers submit TV ads for prior review if there are safety issues, and there are $250,000 fines for running misleading ads (these can go higher in some circumstances). Print ads, but not TV ads, will include a toll-free number and a web site for reporting side effects;
- Pediatric Exclusivity: Drugmakers that conduct studies on new pediatric uses would get six months of market exclusivity.
phil_vardena (Pharm. D.)
Hi dear Ed Silverman,
you are doing a great job.
Conflicted advisory committee members are seriously damaging the people.
Thank you for you effort.
Regards,
Lisa
Its a shame that the Pediatric 6th month exclusivity remains…
Joe Lookout
“- Conflicts of Interest: Over five years, the number of FDA advisory panel members with conflicts of interests will be reduced by 25 percent. This falls short of the complete ban FDA critics sought, given that waivers are offered regularly.”
What a joke - completely unenforceable since it seems right now there is no penalty for not disclosing conflicts of interest (e.g. Howard Scher re: Provenge).
LookoutJoe
Reality
For those who missed it, for the last 3 years Pharma (and PhRMA) have already been posting trial results of hypothesis-testing studies within 1 year of study end if the report has not been submitted to a journal for publication.
http://www.clinicalstudyresults.org.
I’m not really inclined to read the details of the bill tonight (plus legal writing makes my eyes glaze over) but I would be curious to see how the proposed FDA database will differ. Ed, if you can shed any light on this, it would be appreciated.
I’ll be even more curious to see how the FDA decides what’s biased lay reporting and what’s not. That’s a can of worms right there….one person’s nonsignificant trend is another person’s bias.
jason
I have absolutely NO problem with the pediatric exclusion staying put. Honestly having a med branded for an additional 6 months is a small price to pay for ped data. Otherwise those peds/FP/GP would be begging NIH to perform those trials for us. It might not be perfect, but those in the trenches need those results.
Lisa
Jason,
I have no problem with the Pediatric Exclusivity “Per se”.
The problem is that when a Company like GSK,who conducted clinical trials of Paxil in children,knew their drug caused suicide,hostility(HOSTILITY IN THE CONTEXT OF A CLINICAL TRIAL IS HOMICIDE”)and had demonstrated “No Efficacy” and withheld this “vital,life threatening information from the Public.Parents lost their children,while GSK reaped millions in Profits!!!
The lives of Our Nation’s Children Is “PRICELESS”
Reality,
FDA,can of worms…That was mildly put…
Your Cancer: Your Choice » Blog Archive » My thoughts on the FDA bill –Part 1: Drug safety monitoring missing its other half
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Hank
I’m still trying to figure out where this leaves us re: preemption. The House version that have a more “anti” preemption clause. The Senate version was, by my reading, more equivocal. Can anyone clarify this?