All over the world, many patients with serious illnesses can't get access to the medicines they need. The available therapies haven't worked and there are no available clinical trials, or a new drug isn't accessible where they live. For these patients, access to a drug outside of the traditional channels may represent a life-saving treatment option. How can industry help?
Since 1987, FDA-sanctioned "expanded access programs" have enabled patients, under specific circumstances, to access drugs or biologics still in development. Similar regulations exist broadly outside the U.S. but the nomenclature describing these programs differs widely. In an effort to bring much-needed clarity to all of this terminology, we use "Managed Access Programs" as an umbrella term that encompasses a variety of regulatory approaches enabling access to medicines that::