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New FDA Proposal for Experimental Drugs

The Food and Drug Association has recently come up with a proposal that allows seriously ill patients access to unapproved drugs. This proposal also allows a charge for these therapies, though this charge can only cover development costs not profit.

By this proposal, drugs can be offered to patients in the beginning stages of its testing. Only 15% of these drugs usually find approval by the FDA.

Next year a federal court will be rehearing a case by Washington Legal Association and Abigail Alliance for Better Access to Developmental Drugs.
Frank Burroughs, president of Abigail Alliance had a daughter called Abigail who died of cancer. She would have survived if a then unapproved drug Erbitux had been available.

It is hoped that this proposal makes experimental treatments available to a larger group of seriously ill patients.

The approval procedure is very long and time consuming, however unapproved drugs can have dangerous side effects. This proposal gives the patient the option to choose with his doctor as to whether he wants to risk a medicine.
Ref: CBS News

Source: INS News

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