The U. S. Food and Drug Administration (FDA), has set up two new regulations to provide access to experimental drugs to patients who have life threatening conditions or have exhausted all other therapeutic options.

Janet Woodcock, the head of the FDA's drug division, explained that the FDA had formulated a set of rules to allow access to these experimental drugs since 1987 although they were following an informal system to provide similar access since the 1970s.

Experimental drugs are ones that are still being tested for safety and effectiveness and have not yet been approved by the FDA. "We don't know as much about these drugs as we do about approved drugs," Woodcock said.

Woodcock said that the rules made in 1987 were ambiguous, which is why these two new rules have been issued which will go in effect from mid-October.

The first rule illustrates the conditions under which the patients can acquire access to drugs still under experimental status. Some of the prerequisites of getting access to experimental drugs are serious illness, life threatening conditions and absence of any other medical alternatives.

The second rule describes the circumstances under which the companies can charge these patients seeking access to the drugs under investigation. Nevertheless, these companies will be required to supply adequate information to the FDA, that the drug would not be developed if they don't charge the patients.

Information for patients is available at www. fda. gov. The new rules will not hinder the drug approval procedure.

Following the formulation of the two new rules, FDA Commissioner Dr. Margaret A. Hamburg said, "We hope that the two together may result in more patients with serious and life-threatening illnesses receiving access to investigational drugs."