Comments on: User Fees Increase Recalls And Warnings: Study http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/ News, Comment and Conversation Fri, 10 Feb 2012 22:48:45 +0000 http://wordpress.org/?v=2.6.2 By: DV Jr http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-230082 DV Jr Thu, 27 Mar 2008 21:24:21 +0000 http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-230082 It's possible that the reason these drugs came up against the deadline for approval was that FDA was concerned about their safety profile & needed more time to evaluate & debate before approving them. There's an inherent (albeit unintentional) bias in comparing drugs that sailed through approval to drugs that required more scrutiny. It’s possible that the reason these drugs came up against the deadline for approval was that FDA was concerned about their safety profile & needed more time to evaluate & debate before approving them. There’s an inherent (albeit unintentional) bias in comparing drugs that sailed through approval to drugs that required more scrutiny.

]]> By: Bob Freeman http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228583 Bob Freeman Thu, 27 Mar 2008 03:48:01 +0000 http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228583 This is an admitedly cursory review but two red flags cause me some concern: 1) the odds ratios are not that impressive and 2) the 95 percent CIs for all odds ratios are quite large, indicating a lot of statistical noise is present in the analysis. This does not mean the analysis is flawed; rather, this suggests the main value of the study is exploratory and not causal. This is an admitedly cursory review but two red flags cause me some concern: 1) the odds ratios are not that impressive and 2) the 95 percent CIs for all odds ratios are quite large, indicating a lot of statistical noise is present in the analysis.

This does not mean the analysis is flawed; rather, this suggests the main value of the study is exploratory and not causal.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228433 Justice in Michigan Thu, 27 Mar 2008 01:32:25 +0000 http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228433 The study surprised me some because Dan Carpenter's work has generally questioned the arguments over PDUFA. But stats is stats. The study surprised me some because Dan Carpenter’s work has generally questioned the arguments over PDUFA. But stats is stats.

]]> By: Bless The Truth http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228362 Bless The Truth Thu, 27 Mar 2008 00:32:20 +0000 http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228362 User fee is a legal "bribe" that hinder judicious evaluation of NDAS and BLAs. Big pharm use it to buy speed and action. FDA should do away with it to avoid bias. User fee is a legal “bribe” that hinder judicious evaluation of NDAS and BLAs. Big pharm use it to buy speed and action. FDA should do away with it to avoid bias.

]]> By: Lisa Van S http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228164 Lisa Van S Wed, 26 Mar 2008 22:50:08 +0000 http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228164 User Fees Increase Recalls,.... hmmm,.. Maybe because its a bad drug. User Fees Increase Recalls,…. hmmm,.. Maybe because its a bad drug.

]]> By: Dan http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228079 Dan Wed, 26 Mar 2008 21:31:35 +0000 http://www.pharmalot.com/2008/03/user-fees-increase-recalls-and-warnings-study/#comment-228079 PDUFA was clear tangible evidence of the collusion between the FDA and the pharma industry, as this Act has been revised since it's origination to favor the pharma industry. My opinion, thier approval of meds needs to be more strict vs repeated attepts by pharma to achieve superiority at least twice over a placebo. Perhaps the FDA is under-staffed with the intent of the administration, yet the FDA was created to protect public citizens completely instead of maintaining alliances that progressively are more damaging to citizen. Clearly, this is not thier active role, the well-being of U.S. Citizens. More need to speak up on such issues. We have no one to support us, if you think about it, yet as citizens, we dictate the behavior of our government. PDUFA was clear tangible evidence of the collusion between the FDA and the pharma industry, as this Act has been revised since it’s origination to favor the pharma industry. My opinion, thier approval of meds needs to be more strict vs repeated attepts by pharma to achieve superiority at least twice over a placebo. Perhaps the FDA is under-staffed with the intent of the administration, yet the FDA was created to protect public citizens completely instead of maintaining alliances that progressively are more damaging to citizen. Clearly, this is not thier active role, the well-being of U.S. Citizens. More need to speak up on such issues. We have no one to support us, if you think about it, yet as citizens, we dictate the behavior of our government.

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