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Posted By
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March 27, 2008, 10:23 am
Flag as Inappropriate gbyrd
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Subject
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FDA Deadlines May Impact Drug Safety
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You would think that the longer the FDA takes to review a drug, the better decision they would make about its approval, right?
Well that doesn't seem to be the case. According to a recent study done by Harvard researchers published by the AP, "Medicines approved right on deadline by the Food and Drug Administration are more likely to cause safety problems later than those cleared with more time to spare."
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Deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision — either approve or reject — on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority.
Congress tightened the deadline for most drugs to 10 months in 1997.
Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time.
Drugs approved in that just-before-deadline period had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Carpenter concluded.
Sounds like deadlines force them into bad decisions to me. It might be time to get rid of that ticking clock approval system.
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Comments
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March 27, 2008, 11:51 am
Flag as Inappropriate carybyrd says...
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I completely agree and this should be a big wake-up call to everyone.
Drugs like Rezulin, Baycol, Vioxx, Bextra have all been yanked off the market.
Recently we have had a number of drugs that were given a block box warring after the drug was on the market for a number of years; Aranesp, Epogen, Procrit, Avandia, Actos, Enbrel, Amgen, are among the many drugs that were black labeled in 2007 & 2008.
For those of you that don't know what a black box warning label is you can click here: http://en.wikipedia.org/wiki/Black_box_warning
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March 27, 2008, 1:34 pm
Flag as Inappropriate hect says...
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The block boxes started to worry me thinking they just rush anything through. Its like no one cares the bad affects for it, just only the profit margin is whats important.
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March 27, 2008, 2:17 pm
Flag as Inappropriate Chloe says...
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I didn't know that the warnings were described as black box warning, even though I did noticed a box surrounded them. Sometimes after reading those fine prints, I am honestly scared about taking the medication because I feel that I am introducing all kinds of other complications to my body.
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March 28, 2008, 12:33 pm
Flag as Inappropriate sacback says...
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Just because the time is longer to make a decision doesn't mean its going to be the right one. I mean lets be real about it. They may not even be testing them. Makes you wonder.
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