NCPA - Daily Policy Digest - Patients Seek Access to Experimental Drugs

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Patients Seek Access to Experimental Drugs

Makers of some anti-cancer drugs -- with the approval of the Food and Drug Administration (FDA) -- have programs to make the drugs available to cancer patients even before they have received FDA approval. The problem, however, is that the drugs are often in short supply.

Now there is a growing movement to pressure drug companies to pay more attention to the needs of the critically ill.

ImClone Systems, Inc., for example, was deluged with 8,500 requests for an experimental drug called Erbitux after reports about the drug's effectiveness became widespread.

But not only was the drug in short supply, ImClone was apprehensive that widespread distribution of it would deplete the number of patients needed for formal tests in which a control group would receive placebos.

The company was confident the drug would be on the market this spring -- until it received a letter from the FDA last December citing numerous flaws in ImClone's tests for colorectal cancer.

ImClone says that it is cooperating with Bristol-Myers Squibb Co. to initiate an expanded access program.

While ImClone says it has greater production capacity for the drug now than it did a year ago, it is still unclear exactly how big the expanded access program will be, when it would start, who would run it or how many patients would benefit.

That may require a system to pick the beneficiaries at random -- a lottery, in effect.

Source: Justin Gillis, "Patients Press Pleas for Cancer Drugs," April 7, 2002.

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