Guest guest Posted June 1, 2002 Report Share Posted June 1, 2002 > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > government agency. They allow a dangerous diet drug on the market and > hassle > OTC's about wording on the labels of their products?? > > For FDA-approved prescriptives, I thought the key was demonstrating > that an ingredient is more effective than placebo in treating a > condition. A safety profile must be filed, and the FDA will not > approve (or will recall) something that is shown to be dangerous, but > a drug doesn't need to be safe to be approved -- just efficacious. > The FDA may be less trustworthy in the near future: < > Go to http://www.washingtonpost.com/wp-srv/popjs/politics.htm for the whole story on funding of the FDA by drug companies. Rene Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 1, 2002 Report Share Posted June 1, 2002 > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > government agency. They allow a dangerous diet drug on the market and > hassle > OTC's about wording on the labels of their products?? > > For FDA-approved prescriptives, I thought the key was demonstrating > that an ingredient is more effective than placebo in treating a > condition. A safety profile must be filed, and the FDA will not > approve (or will recall) something that is shown to be dangerous, but > a drug doesn't need to be safe to be approved -- just efficacious. > The FDA may be less trustworthy in the near future: < > Go to http://www.washingtonpost.com/wp-srv/popjs/politics.htm for the whole story on funding of the FDA by drug companies. Rene Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 1, 2002 Report Share Posted June 1, 2002 > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > government agency. They allow a dangerous diet drug on the market and > hassle > OTC's about wording on the labels of their products?? > > For FDA-approved prescriptives, I thought the key was demonstrating > that an ingredient is more effective than placebo in treating a > condition. A safety profile must be filed, and the FDA will not > approve (or will recall) something that is shown to be dangerous, but > a drug doesn't need to be safe to be approved -- just efficacious. > The FDA may be less trustworthy in the near future: < > Go to http://www.washingtonpost.com/wp-srv/popjs/politics.htm for the whole story on funding of the FDA by drug companies. Rene Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 2, 2002 Report Share Posted June 2, 2002 There's a problem with that link, Rene, but from what you quoted, it reads like old concerns from the mid-Clinton years, even though you say it's a new article. None of which has anything to do with my original point anyway. Marjorie Marjorie Lazoff, MD > > > > > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > > government agency. They allow a dangerous diet drug on the market and > > hassle > > OTC's about wording on the labels of their products?? > > > > For FDA-approved prescriptives, I thought the key was demonstrating > > that an ingredient is more effective than placebo in treating a > > condition. A safety profile must be filed, and the FDA will not > > approve (or will recall) something that is shown to be dangerous, but > > a drug doesn't need to be safe to be approved -- just efficacious. > > > > The FDA may be less trustworthy in the near future: > > < industry funding of the FDA will undermine its independence and credibility > with the public. Some also worry that the user fees -- plus the accompanying > requirements for the FDA to act on drug applications within set periods of > time -- are encouraging the agency to move too quickly when it reviews new > drug applications and without enough attention to safety. Nine drugs approved > in the past 10 years were later withdrawn because of deadly side effects.>> > > Go to http://www.washingtonpost.com/wp-srv/popjs/politics.htm for the whole > story on funding of the FDA by drug companies. > > Rene > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 2, 2002 Report Share Posted June 2, 2002 There's a problem with that link, Rene, but from what you quoted, it reads like old concerns from the mid-Clinton years, even though you say it's a new article. None of which has anything to do with my original point anyway. Marjorie Marjorie Lazoff, MD > > > > > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > > government agency. They allow a dangerous diet drug on the market and > > hassle > > OTC's about wording on the labels of their products?? > > > > For FDA-approved prescriptives, I thought the key was demonstrating > > that an ingredient is more effective than placebo in treating a > > condition. A safety profile must be filed, and the FDA will not > > approve (or will recall) something that is shown to be dangerous, but > > a drug doesn't need to be safe to be approved -- just efficacious. > > > > The FDA may be less trustworthy in the near future: > > < industry funding of the FDA will undermine its independence and credibility > with the public. Some also worry that the user fees -- plus the accompanying > requirements for the FDA to act on drug applications within set periods of > time -- are encouraging the agency to move too quickly when it reviews new > drug applications and without enough attention to safety. Nine drugs approved > in the past 10 years were later withdrawn because of deadly side effects.>> > > Go to http://www.washingtonpost.com/wp-srv/popjs/politics.htm for the whole > story on funding of the FDA by drug companies. > > Rene > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 2, 2002 Report Share Posted June 2, 2002 There's a problem with that link, Rene, but from what you quoted, it reads like old concerns from the mid-Clinton years, even though you say it's a new article. None of which has anything to do with my original point anyway. Marjorie Marjorie Lazoff, MD > > > > > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > > government agency. They allow a dangerous diet drug on the market and > > hassle > > OTC's about wording on the labels of their products?? > > > > For FDA-approved prescriptives, I thought the key was demonstrating > > that an ingredient is more effective than placebo in treating a > > condition. A safety profile must be filed, and the FDA will not > > approve (or will recall) something that is shown to be dangerous, but > > a drug doesn't need to be safe to be approved -- just efficacious. > > > > The FDA may be less trustworthy in the near future: > > < industry funding of the FDA will undermine its independence and credibility > with the public. Some also worry that the user fees -- plus the accompanying > requirements for the FDA to act on drug applications within set periods of > time -- are encouraging the agency to move too quickly when it reviews new > drug applications and without enough attention to safety. Nine drugs approved > in the past 10 years were later withdrawn because of deadly side effects.>> > > Go to http://www.washingtonpost.com/wp-srv/popjs/politics.htm for the whole > story on funding of the FDA by drug companies. > > Rene > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 2, 2002 Report Share Posted June 2, 2002 > There's a problem with that link, Rene, but from what you quoted, it > reads like old concerns from the mid-Clinton years, even though you > say it's a new article. None of which has anything to do with my > original point anyway. > > Marjorie > Marjorie, Sorry about the bad link. This one should work: http://www.washingtonpost.com/wp-dyn/articles/A60149-2002May22.html I think I was replying to someone else's comment (below) on the FDA. User-fees did start in 1992, but are gaining considerable momentum (and money). I feel it is a bad idea to assume a drug is safe just because it is FDA approved. By reading many posts on many lists, a good portion of the population believe this: " If the FDA says it's ok, and my doctor says it's ok, then ok! I'll try it! " I'm glad you mention waiting some time before prescribing a newly approved drug. When it comes to a disorder that affects a persons self image as in rosacea and obesity, people are so willing to grasp the first thing on the market not even thinking of the consequences. I was there at one time. Now you can't force me to take a drug, knowing I am controlling my rosacea with diet. I'm not completely free (because it is so hard to stay away from chocolate), but am better than I was while taking the pills and putting on the creams. Rene (I'm a little passionate about this subject. I apologize if I offend anyone.) > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > government agency. They allow a dangerous diet drug on the market and > hassle > OTC's about wording on the labels of their products?? > > For FDA-approved prescriptives, I thought the key was demonstrating > that an ingredient is more effective than placebo in treating a > condition. A safety profile must be filed, and the FDA will not > approve (or will recall) something that is shown to be dangerous, but > a drug doesn't need to be safe to be approved -- just efficacious. > The FDA may be less trustworthy in the near future: < > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 2, 2002 Report Share Posted June 2, 2002 > There's a problem with that link, Rene, but from what you quoted, it > reads like old concerns from the mid-Clinton years, even though you > say it's a new article. None of which has anything to do with my > original point anyway. > > Marjorie > Marjorie, Sorry about the bad link. This one should work: http://www.washingtonpost.com/wp-dyn/articles/A60149-2002May22.html I think I was replying to someone else's comment (below) on the FDA. User-fees did start in 1992, but are gaining considerable momentum (and money). I feel it is a bad idea to assume a drug is safe just because it is FDA approved. By reading many posts on many lists, a good portion of the population believe this: " If the FDA says it's ok, and my doctor says it's ok, then ok! I'll try it! " I'm glad you mention waiting some time before prescribing a newly approved drug. When it comes to a disorder that affects a persons self image as in rosacea and obesity, people are so willing to grasp the first thing on the market not even thinking of the consequences. I was there at one time. Now you can't force me to take a drug, knowing I am controlling my rosacea with diet. I'm not completely free (because it is so hard to stay away from chocolate), but am better than I was while taking the pills and putting on the creams. Rene (I'm a little passionate about this subject. I apologize if I offend anyone.) > How then does the FDA explain Phen-Phen?? I think the FDA is an atypical > government agency. They allow a dangerous diet drug on the market and > hassle > OTC's about wording on the labels of their products?? > > For FDA-approved prescriptives, I thought the key was demonstrating > that an ingredient is more effective than placebo in treating a > condition. A safety profile must be filed, and the FDA will not > approve (or will recall) something that is shown to be dangerous, but > a drug doesn't need to be safe to be approved -- just efficacious. > The FDA may be less trustworthy in the near future: < > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 14, 2004 Report Share Posted July 14, 2004 Hi, I'm anxiously looking for FDA approval. Does anyone know if resurfacing is on the docket yet? I've seen hopes for June which apparently didn't materialize, hopes for fall and recently some idea that they won't be looking at it until next year. Does anyone know how to find out what the schedule is? Is there a way to let the FDA know that lots of people want this review to be a priority? Quote Link to comment Share on other sites More sharing options...
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