Draft proposals open path to experimental drugs
The FDA is preparing two proposals that would make it easier for patients to obtain experimental drugs as a last resort. In one proposal, which has to be approved by the OMB, the agency is spelling out how doctors and patients can obtain unapproved therapies for dangerous ailments. And in another proposal, the FDA is spelling out how drug developers can sell the therapies on a nonprofit basis. Patient advocacy groups, particularly in oncology, have been clamoring for access to experimental drugs for years. These new draft proposals would clarify how that can be done. Experts caution, though, that patients should be protected from obtaining drugs that could pose serious safety risks.
- read The Wall Street Journal report on the new draft proposals
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New rules could relax standards for Phase I drugs. Report
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Comments
By Anonymous | Posted 5:25pm | November 9, 2006
Experimental drugs are not on the market for a reason. I believe the drug is in the stage of experimental because the drug was either unhuman or unsafe. There is a big risk for humans to be used as "test dummies" instead of testing the drugs on rats to be sure of public safety.
By Anonymous | Posted 2:05pm | November 19, 2006
Experimental drugs should be available to patients that have no alternatives available. Patients must understand that use of these drugs could hasten their demise. At the same time, care should be taken to make these drugs available to only patients that will have a very high risk of death within a year due to an illness that is otherwise untreatable.
By Anonymous | Posted 6:08pm | February 14, 2007
to tell a dying patient u have nothing to offer them, most drs could care, less nor the drug co, nor the gov officials, there in it for the money ,they can usually find a drug that will end their life, they do it intentially now, so what is the difference alot of patients die from or get sick from the drugs anyways so why give them a drug to try, it may end their life anyways I say let sleeping dogs lie
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