Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or. Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used. Expanded access or compassionate use is the use of an unapproved drug or medical device . Randall, who had glaucoma, had successfully used the Common Law doctrine of necessity to argue against criminal charges of marijuana.
compassionate act Expanding
FDA also provides a bulwark against exploitation of vulnerable patients and ensures that IRB review will be obtained. Providing an investigational drug is not always in the best interest of the patient or the public health. These ethical and practical challenges require the continued resources, cooperation, and expertise of all involved.
The views expressed in this article are those of the authors and not necessarily those of the U. Food and Drug Administration. Declaration of Conflicting Interests. National Center for Biotechnology Information , U. Ther Innov Regul Sci. Author manuscript; available in PMC May Author information Copyright and License information Disclaimer.
The publisher's final edited version of this article is available at Ther Innov Regul Sci. See other articles in PMC that cite the published article. Introduction Expanded access is the use of an investigational new drug outside of a clinical trial in patients for the diagnosis, monitoring, or treatment of a serious disease or condition. Individual Patient Access to Investigational Drugs In recent years, there has been an increased interest in expanded access from both the general public and lawmakers.
Footnotes The views expressed in this article are those of the authors and not necessarily those of the U. Declaration of Conflicting Interests No potential conflicts were declared. Updated August 5, Food and Drugs, 21 C. Caplan A, Ray A. The ethical challenges of compassionate use. Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med. Updated February, 23 Published June 2, Expanded access of investigational drugs: Updated October 24, Support Center Support Center.
Various regulatory mechanisms exist in different countries to provide expanded access to investigational medicinal products and, as a result, regional variations in expanded access will occur. It is important to remember that investigational medicinal products have not yet received regulatory approval; thus, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product.
Gilead uses the following criteria for considering requests to provide access to individual patients for expanded access: Treating physicians submit expanded access requests on behalf of patients to Gilead at CompassionateAccess gilead.
Medical professionals at Gilead who are familiar with the data collected on the investigational medicinal product evaluate each request and respond based on the scientific evidence available at the time of the request and the criteria listed above. All individual patient use requests submitted by a treating physician must include the following information to be considered:.
A response for expanded access is typically received by the requesting physician within 30 days with either: Our Expanded Access Program for cell therapy varies regionally as a result of the unique regulatory mechanisms in different countries worldwide.
Since investigational medicinal products have not yet received regulatory approval, their potential risks and benefits are not yet established.
It is important for physicians and patients to consider all possible benefits and risks when seeking access to an investigational medicinal product. Gilead will evaluate these requests individually.
Overview of FDA’s Expanded Access Program for Investigational Drugs
FDA's expanded access program (also known as “compassionate use”) The federal right to try law also removes any liability on the part of the. AMERICANS FOR SAFE ACCESS. COMPASSIONATE ACCESS, RESEARCH. EXPANSION, AND RESPECT STATES ACT. CARERS. (continued on back). The CARERS Act is the first comprehensive medical cannabis bill to be introduced in the. U.S. Senate (S. ), and has an identical companion bill in the House.