The FDA has long supported the use of investigational new drugs outside the clinical trial setting to treat unmet medical needs, a process commonly referred to as expanded access or compassionate use.
However, the agency recognizes that improvements must continuously be made to the formal FDA guidelines that govern how patients and physicians receive approval to use a drug through expanded access.
For example, last year, the FDA released a streamlined application form for physician’s applying for single patient expanded access. This new form, Form FDA 3926, considerably reduced the number of required information fields and cut the expected completion time down from a number of hours to 45 minutes. For more information on this, check out the FDA’s guidance document.
Building on this early effort, FDA Commissioner, Scott Gottlieb, this week announced the removal of another potential burden physicians face when applying for expanded access on behalf of their patients.
The FDA has considered it necessary for a physician to receive approval from an Institutional Review Board (IRB) before treating a patient with an investigational new product. An IRB is made up of a group of appropriately selected individuals who are charged with reviewing any proposed research in the US which involves human subjects. Their job is to ensure that the rights and health and wellbeing of participants are protected.
However, assembling the full board can be difficult and can cause unnecessary delays for patients waiting to receive treatment. Under the revised system, Gottlieb’s FDA will now require physicians to receive approval from just one IRB member, as opposed to the full board. Gottlieb strongly believes that this change will reduce the time taken to approve expanded access use of a product while still providing important patient safeguards.
To learn more, visit the FDA website to read Gottlieb’s official statement.