FDA Explains Emergency Expanded Access Application Process
The US Food and Drug Administration (FDA) has laid out the process by which doctors can access an investigational drug for treatment in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures.
The release of the MAPP coincides with a bill passed in the Senate and making its way through the House that aims to ease the process by which terminal patients can access such investigational drugs, though the bill essentially cuts FDA out of the process. The bill, which is part of the "Right-to-Try" movement, does not take into consideration that FDA signs off on such requests about 99% of the time.
And as the new MAPP reveals, FDA can only do so much in helping a patient access a treatment that a company is developing.
"FDA cannot compel a pharmaceutical company to provide access, including emergency access, to its investigational drug for treatment use. When a company provides access to its investigational drug for treatment use, it is doing so voluntarily," FDA explains.
As part of FDA’s process, physicians must include the letter of authorization from the pharmaceutical company that permits the physician to refer to the company’s IND to support the physician’s expanded access request.
And because of the urgency of the requests, FDA says it reviews such expanded access inquiries immediately upon receipt.
"Although access to an investigational drug for an individual patient in an emergency situation may be requested and authorized through submission of a protocol for such use by an investigational new drug application (IND) holder (e.g., pharmaceutical company) to its existing IND, this situation is not common and is not addressed in this MAPP," FDA adds. "Most emergency access is requested and authorized through submission of a protocol under a new IND (EIND). This scenario (emergency access requested and allowed under an EIND) is addressed in this MAPP."