FDA Proposes Rules for Use of Experimental Treatments
The Food and Drug Administration has proposed allowing experimental drugs and devices to be studied in certain life-threatening situations where patients cannot give informed consent for their use.
Among other things, the rules announced Thursday would allow the use of such items in emergency conditions where available treatments are unproven or unsatisfactory, and the benefits of the experimental treatment are considered “reasonable.”
“The proposed rules will enable us to get the information we need to approve new and better therapies for use in emergency medicine,” said FDA Commissioner David A. Kessler. “It is important that, in emergency situations, health care professionals have access to the tools that will be most beneficial to their patients.”
The proposals follow criticism from conservative groups that the agency has blocked the use of devices that might help patients in desperate situations. The groups frequently have cited the example of the “cardiopump” experimental resuscitation device, although studies have shown the pump to be no more effective than other means of resuscitation.
The need for emergency-use products often comes in cases when the patient is unconscious and there is not enough time to contact a legal representative authorized to give consent for the use of an unapproved product or drug. These patients are often denied a potentially promising new therapy and studies of these products are difficult to conduct.
The new rules require that an independent physician and a hospital’s institutional review board--a committee of experts and lay persons who review research proposals--agree that the experimental device under study would address a life-threatening situation.
The rule requires that available treatments be “unproven or unsatisfactory” and that the risks and benefits of the experimental treatment are reasonable in light of what is known about the medical condition and the risks and benefits of other therapies.
Furthermore, the proposal stipulates that the research is necessary to determine what intervention is best and that the research could not otherwise be conducted except under emergency life-threatening situations where informed consent is not always possible.
Sam Kazman, general counsel for the Competitive Enterprise Institute, one of the FDA’s most persistent critics, said the agency “acts as if it has just discovered the importance of getting new therapies to patients. Well, welcome to the real world, Dr. Kessler, but would you mind telling us where you’ve been? FDA is removing a roadblock to the use of emergency therapies, but it refuses to admit that it . . . was responsible for that roadblock.”
