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Date:  September 21, 1995
For Release:  Immediately
Contact:  Betsy Adams, FDA (301) 443-3285 (Home) (301) 924-0932

The proposals are designed both to clarify the rules for the testing of unapproved drugs and devices that may save lives and also provide safeguards for patients.

"It's essential to protect patients, and it's also important to give them a chance to use new therapies," said Health and Human Services Secretary Donna E. Shalala. "The proposals accomplish both. They also have broad support from industry, medical and consumer groups."

"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, M.D. "It is important that in emergency situations health care professionals have access to the tools that will be most beneficial to their patients."

Emergency-use products often have to be used in situations when the patient is unconscious and there is no time to locate a legal representative authorized to give consent for the use of an unapproved device or medicine. As a result, these patients are being denied the benefits of a promising new therapy, and some studies involving emergency-use products are encountering problems in enrolling patients in clinical trials.

The proposals address the issue of informed consent by providing that an independent physician and a hospital's institutional review board -- a committee of experts and lay persons currently established to review research -- must agree that the trial addresses a life-threatening situation and that other criteria are met.

The regulations would apply under these conditions:

• patients are in a life-threatening situation
• available treatments are unproven or unsatisfactory
• research is necessary to determine what intervention is best
• research could not be conducted otherwise
• informed consent is not feasible because a patient cannot consent due to a medical condition, intervention must be done before consent from a patient's representative is feasible, and consent cannot be obtained in advance because prospective subjects cannot reliably be identified ahead of time
• risks and benefits of the experimental treatment are reasonable in light of what is known about the condition and risks and benefits of other therapies
• Also, additional protections will be provided to patients. These protections include consulting with the community, public disclosure of the study design and attendant risks prior to its commencement, public disclosure of study results when completed, use of an independent data and safety monitoring board, and others as appropriate.

An approved informed consent document would have to be available for use in cases where informed consent from the patient or a representative can be obtained. In addition, patients or their representatives would have to be informed about the study as soon as possible and told that the patient may withdraw from the study, or be withdrawn by the representative, without penalty.

The proposed regulations are being published in the Federal Register on Sept. 21. Comments must be received within 45 days and should be sent to Dockets Management Branch (HFA-305), Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, Md. 20857.

FDA is a Public Health Service agency in HHS.