The PDUFA Debate: Senate Remarks
1 CommentBy Ed Silverman // April 30th, 2007 // 3:58 pm
There won’t be any vote tonight, but there does appear to be a compromise in the works on the two-year moratorium on DTC advertising. Over the past week, a coalition of drugmakers, advertising agencies, media companies and assorted free-speech advocates galvanized supporters to protest the provision.
Interestingly, neither Kennedy nor Enzi mentioned the adveritising issue in any significant fashion in their prepared remarks. Here are a few qiuck excerpts:
Sherrod Brown (D-Ohio): He called the measure “a drug safety bill, a drug access bill, not a drug industry bill.” He accused the drug industry of “consistently placing its own self interest” above the public interest.
Ted Kennedy (D-Mass) “In many cases, companies have hidden evidence of safety problems. Our bill addresses this abuse by including a public database of all clinical trials and their results. A company will no longer be able to conduct a trial, and then hide the results if they don’t show what the company wanted.”
Mike Enzi (R-Wyoming) “With this new toolbox, FDA has the ability to identify side effects after the drug is marketed through active surveillance. FDA also has the authority to request a separate study or clinical trial to learn more about a particular, potential safety problem. FDA can also obtain timely label changes for the first time under the new system.”
Here’s the Senate bill.
Hat Tip to Robert Cohen of The Star-Ledger of New Jersey
[tags]PDUFA[/tags]
Melody
With this new toolbox, FDA has the ability to identify side effects after the drug is marketed through active surveillance. FDA also has the authority to request a separate study or clinical trial to learn more about a particular, potential safety problem. FDA can also obtain timely label changes for the first time under the new system.
Sounds great! But giving them the authority is only one issue. Expecting FDA to use that authority in a timely and appropriate manner for patient benefit instead of industry benefit still seems to be a matter of concern. Will Congress maintain its oversight responsibility? Will we need an overseer to oversee the FDA?
The adverse event reporting is so broken many consider it beyond repair. Without an adequate reporting system, how can FDA POSSIBLY identify problems. Active surveillance? Was FDA actively surveilling wheat gluten? Were they actively surveilling all those pesky “anecdotal” stories re: Zyprexa? Vioxx? Resulin? Oraflex? How about rDNA insulin?