An expanded access agreement, also known as an access program or compassionate use program, is a special arrangement between a drug manufacturer and a patient, physician or healthcare provider that allows the patient to access an unapproved drug outside of a clinical trial. This agreement is typically used for individuals who have a serious or life-threatening illness for which there are no available treatment options.
Expanded access agreements are generally used in cases where a patient has exhausted all approved treatment options and is unable to enroll in a clinical trial due to specific eligibility requirements or other circumstances. In these cases, an expanded access agreement can provide a way for the patient to access a potentially life-saving drug that has not yet been approved by the FDA.
Under the agreement, the drug manufacturer provides the drug to the patient at no cost or a reduced cost, and the patient agrees to participate in ongoing monitoring and reporting of their experience with the drug. The physician overseeing the patient`s treatment is responsible for obtaining approval for the use of the drug from the FDA.
While expanded access agreements are not a substitute for clinical trials, they can provide a way for patients to access new treatments that could potentially save their lives. These agreements are often used in cases where clinical trials are not feasible or where the drug is still in the early stages of development.
It`s important to note that expanded access agreements are not available for all unapproved drugs and that the process of obtaining approval can be complex and time-consuming. However, for patients who have exhausted all other treatment options, an expanded access agreement can provide a ray of hope in an otherwise desperate situation.
As a professional, it`s important to remember that articles on medical topics need to be accurate and well-researched, with a focus on providing helpful information to readers. By providing clear and concise information on expanded access agreements, we can help patients and healthcare providers better understand this important resource.
