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Bravo! The less the Gov. has to do with it the better it would work. David Meigs [log in to unmask] ----- Original Message ----- From: "Marjorie L. Moorefield" <[log in to unmask]> To: <[log in to unmask]> Sent: Thursday, November 02, 2000 8:25 AM Subject: FDA too slow/Rita > No Rita, > Not Gratis, > In all reality everyone who purchases > a drug pays twice, once as a taxpayer,and once as a consumer. > Do away with the FDA ,as an entity under US Department of Health > and Human Services, and set it up with a group of scientists or as > a private enterprise, using the funding currently paid to the FDA. > Drug Companies pay > to have drugs tested too, get them in on a re-evaluation of the FDA. > There just has to be a better way,and the history of the FDA > proves they are too slow!!! > > The average time for approval from the FDA is 18 months, > All PWP's know what 18 months does to their bodies, > especially after they have had it a number of years. > How many new drugs do you think are sitting there waiting > for FDA approval which would be of use to us now? > > Things have changed since the FDA was set up in 1906 , and if > one reads the History of the FDA you'll see it takes them too > long to get anything done, always has! > > I'm including this for persons who don't have research capabilities: > This is from Encarta 1998, which I have in my computer. > There are many, many books written on the history of the FDA > is someone cares to read more about it, go to your favorite library. > If they don't have a book on it, they will be happy to do an > ILL (inter library loan) for you, and they will gladly find titles > of books for you on the History of the FDA. > > > <SNIP> > The Federal Food, Drug, and Cosmetic Act was enacted in 1938 requiring that > new drugs be safe for humans; however, it did not require that > manufacturers prove their drugs' effectiveness. It would be 24 years before > legislation was passed that would require proof of the efficacy of new > drugs (the Kefaver-Harris Amendments, 1962). Enforcement of this law was > entrusted to the FDA. > Two laws enacted in the 1960s strengthened the FDA's efforts to reduce drug > abuse. The Drug Abuse Control Amendments of 1965 provided penalties for the > illegal sale or possession of stimulants, sedatives, and hallucinogens, and > the Narcotic Addict Rehabilitation Act of 1966 set up a federal program for > addicts that provided them with the option of receiving treatment for their > drug problems in place of a prison sentence. > In 1970 the Comprehensive Drug Abuse Prevention and Control Act established > rules for manufacturing and prescribing habit-forming drugs. It stipulated > that physicians can prescribe all drugs, but a special license is required > to prescribe drugs with a high abuse potential. This license is issued by > the Drug Enforcement Administration. > The Anti-Drug Abuse Acts, signed into law in 1986 and 1988, set up funding > for the treatment of drug abuse and for the creation of law-enforcement > programs to fight the illegal sale of drugs. These acts also detailed > severe punishments for individuals selling and possessing drugs illegally. > Harsh penalties for using anabolic steroids (hormones that promote the > storage of protein and the growth of tissue that are sometimes abused by > competitive athletes) were included in the 1988 act, along with the > requirement that all alcoholic beverages be labeled with warnings about > alcohol's potentially dangerous effect on the body. The 1988 act also > established the Office of National Drug Control Policy to develop an action > plan that would involve the public, as well as private agencies, in > eliminating the illegal sale of drugs; in helping individuals who use drugs > to stop; and in preventing nonusers from ever starting to use drugs. > The U.S. government and its regulatory agencies continually monitor the > development and use of all drugs sold in the United States to ensure that > the American public has access only to drugs that are safe and effective. > Recently, the FDA introduced legislation requiring warning labels on all > over-the-counter medication after research indicated that the nonaspirin > pain reliever acetaminophen can cause liver damage when taken in high doses > with large quantities of alcohol. > >END> > > Maybe it's possible that the FDA has too much to do, and not enough help, > but it certainly > needs to be brought up to speed, 18 months for approval is unacceptable in > this century. > > just me, > Marjorie > 68/58/55 > > > > > At 09:39 AM 11/02/2000 -0500, you wrote: > >Marjorie said....... > > > >"MOHO, the FDA gives a new meaning to the expression "Slower than molasses > >on a cold day in January". Also in my own humble opinion, the FDA should=20 > >be removed from > >Federal Control and turned over to a private group of scientists!!!!! But=20 > >then no > >one ever asked me for my opinion!" > > > >and Rita asks.......Who is going to pay for the FDA program if the taxpayers > >don't? > >Someone must foot the bill.....where will the private group of scientists get > >the money?.......or is this just to be a "gratis" thing that is added on to > >the research platter? > > > >Rita Weeks 56/11