Experimental Drugs for the Desperately Ill: A Progress Report

Young, Frank E., FDA Consumer

Experimental Drugs for the Desperately Ill: A Progress Report

Less than a year ago, FDA established a regulation that offers a way to provide promising -- but still experimental -- drugs to desperately ill patients.

The regulation is known as the "treatment IND" (for investigational new drug) rule. It is based on the premise that there are times when an experimental drug shows such promise -- especially for a life-threatening condition for which there is no other hope -- that it seems unacceptable to withhold it from desperate patients. (See "Experimental Drugs for the Desperately Ill" in the June 1987 FDA Consumer.) The regulation, which went into effect last June 22, makes it possible to bring such promising and important drugs to desperately ill patients much earlier than was previously the case.

As we approach the one-year mark of the treatment IND rule, I am pleased to provide this progress report on its success to date. I think we can be gratified that the regulation has already proven its worth by providing new treatment choices -- and potentially life-saving ones at that -- for many critically ill patients.

As this column went to press, FDA had approved three important treatment IND requests.

The first approval was given last October to the Massachussets Department of Public Health for use of a biological product in patients …

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Publication information: Article title: Experimental Drugs for the Desperately Ill: A Progress Report. Contributors: Young, Frank E. - Author. Magazine title: FDA Consumer. Volume: 22. Issue: 4 Publication date: May 1988. Page number: 2+. © 1999 U.S. Government Printing Office. COPYRIGHT 1988 Gale Group.

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