What is expanded access?
Expanded access programs provide drugs that are not yet FDA approved, usually for free, once there is enough information to show safety and efficacy. Expanded access programs allow the drug company an opportunity to collect information about how the drug works in very large groups of people who are not in a controlled clinical trial. In addition, expanded access programs allow people with HIV access to a new treatment before it’s available to the general public for purchase. There are usually a limited number of spots and certain requirements you must meet to be eligible for expanded access If you feel you may benefit from an experimental treatment, but you do not meet the inclusion criteria for the clinical trial testing this treatment, you should talk to your doctor to find out if expanded access is available.
These are all programs that helped set the stage for accelerated approval. They are still used today to help make promising experimental treatments available to people with life-threatening diseases who aren’t benefiting from approved treatments and don’t qualify for clinical trials. Expanded access is the general term for any program that allows doctors and their patients to gain access to medications outside of controlled clinical trials before the FDA officially approves them. Prior to the activism surrounding HIV/AIDS drug development, expanded access usually came in the form of compassionate use allowances, which were often quite cumbersome. First, a doctor had to get permission from a company to use its experimental agent in a desperately ill patient (lots of paperwork). If permission was granted, the doctor then had to request authorization from the FDA to use the drug in his or her patient (even more paperwork). This process sometimes took weeks or months. In response to the ac
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. Most human use of investigational new drugs takes place in controlled clinical trials conducted to assess the safety and efficacy of new drugs. Data from these trials are used to determine whether a drug is safe and effective, and serve as the basis for the drug marketing application. Sometimes, patients do not qualify for these controlled trials because of other health problems, age, or other factors, or are otherwise unable to enroll in such trials (e.g., a patient may not live sufficiently close to a clinical trial site). For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug, FDA regulations enable manufacturers of such drugs to provide th
