I am trying to design a label for my stem cells since the FDA has declared them to be drugs. Should I wear some kind of bracelet or something around my neck or what does anyone think would be appropriate? Perhaps, a nice tatoo on my behind would be good so that it is permanently there come rain or come "moon" shine.
What warnings should I include? Will the advisory board visit me at my home and draw some blood so they can determine whether I am fit for approval? Do I need to vacuum (GASP) if they do want to visit? Remember, I suffer from severe NOVAC. There are so many questions to be answered. With so many of us out there needing approval, how will they do this? When I was little, I always wondered how Santa Claus could get to all the houses in just one night. I never thought I would be wondering this same thing as an adult about the FDA! And the biggest worry of all is how long will they let me stay on the market? Now, that's a scary thought.
Gaps, Tensions, and Conflicts in the FDA Approval Process:: Conflicts of Interest in the Approval Process
Posted on MedScape
Conflicts of Interest in the Approval Process
Another problem that has recently come to light in the FDA approval process is conflict of interest on the part of some members of the agency's 18 drug advisory committees. These committees include about 300 members, and are influential in recommending whether drugs should be approved, whether they should remain on the market, how drug studies should be designed, and what warning labels should say. The decisions of these committees have enormous financial implications for drug makers.
A report by USA Today indicated that roughly half the experts on these panels had a direct financial interest in the drug or topic they were asked to evaluate. The conflicts of interest included stock ownership, consulting fees, and research grants from the companies whose products they were evaluating. In some cases, committee members had helped to develop the drugs they were evaluating. Although federal law tries to restrict the use of experts with conflicts of interest, USA Today reported that FDA had waived the rule more than 800 times between 1998 and 2000. FDA does not reveal the magnitude of any financial interest or the drug companies involved.[27]
Nonetheless, USA Today reported that in considering 159 Advisory Committee meetings from 1998 through the first half of 2000, at least one member had a financial conflict of interest 92% of the time. Half or more of the members had conflicts at more than half the meetings. At 102 meetings that dealt specifically with drug approval, 33% of committee members had conflicts.[27] The Los Angeles Times reported that such conflicts were present at committee reviews of some recently withdrawn drugs.[18]
The FDA official responsible for waiving the conflict-of-interest rules pointed out that the same experts who consult with industry are often the best for consulting with the FDA, because of their knowledge of certain drugs and diseases. But according to a summary of the USA Today survey reported in the electronic American Health Line, "even consumer and patient representatives on the committees often receive drug company money."[28] In 2001, Congressional staff from the House Government Reform Committee began examining the FDA advisory committees, to determine whether conflicts of interest were affecting the approval process.[2
What warnings should I include? Will the advisory board visit me at my home and draw some blood so they can determine whether I am fit for approval? Do I need to vacuum (GASP) if they do want to visit? Remember, I suffer from severe NOVAC. There are so many questions to be answered. With so many of us out there needing approval, how will they do this? When I was little, I always wondered how Santa Claus could get to all the houses in just one night. I never thought I would be wondering this same thing as an adult about the FDA! And the biggest worry of all is how long will they let me stay on the market? Now, that's a scary thought.
Gaps, Tensions, and Conflicts in the FDA Approval Process:: Conflicts of Interest in the Approval Process
Posted on MedScape
Conflicts of Interest in the Approval Process
Another problem that has recently come to light in the FDA approval process is conflict of interest on the part of some members of the agency's 18 drug advisory committees. These committees include about 300 members, and are influential in recommending whether drugs should be approved, whether they should remain on the market, how drug studies should be designed, and what warning labels should say. The decisions of these committees have enormous financial implications for drug makers.
A report by USA Today indicated that roughly half the experts on these panels had a direct financial interest in the drug or topic they were asked to evaluate. The conflicts of interest included stock ownership, consulting fees, and research grants from the companies whose products they were evaluating. In some cases, committee members had helped to develop the drugs they were evaluating. Although federal law tries to restrict the use of experts with conflicts of interest, USA Today reported that FDA had waived the rule more than 800 times between 1998 and 2000. FDA does not reveal the magnitude of any financial interest or the drug companies involved.[27]
Nonetheless, USA Today reported that in considering 159 Advisory Committee meetings from 1998 through the first half of 2000, at least one member had a financial conflict of interest 92% of the time. Half or more of the members had conflicts at more than half the meetings. At 102 meetings that dealt specifically with drug approval, 33% of committee members had conflicts.[27] The Los Angeles Times reported that such conflicts were present at committee reviews of some recently withdrawn drugs.[18]
The FDA official responsible for waiving the conflict-of-interest rules pointed out that the same experts who consult with industry are often the best for consulting with the FDA, because of their knowledge of certain drugs and diseases. But according to a summary of the USA Today survey reported in the electronic American Health Line, "even consumer and patient representatives on the committees often receive drug company money."[28] In 2001, Congressional staff from the House Government Reform Committee began examining the FDA advisory committees, to determine whether conflicts of interest were affecting the approval process.[2
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