Common Rule Infographic

by Jim Gearhart

FDA Eases Ethics Review Requirements for Expanded Access Requests

Over the past few years, lawmakers and patient advocacy groups have called for greater access to experimental treatments for the seriously ill. A common term for the movement is Right to Try. Over 35 state governments have passed Right to Try laws, and in August the Senate passed a bill that proposes a national Right to Try policy. As legislative activity in support of Right to Try increases, the FDA has been working to streamline its expanded access review requirements and processes.

 

FDA Strives to Align with Expanded Access Opinion

One of the FDA’s latest initiatives is to reduce the time and effort required for ethics reviews of expanded access requests. Expanded access is, at its core, a way for seriously ill patients who have run out of treatment options to gain access to a drug or device that has not yet been approved for sale or use by the FDA. A request for expanded access requires review by the FDA and an IRB. As of October 2017, however, the FDA will allow one member of an existing IRB to review and approve an expanded access request rather than requiring the entire board’s approval. This change could save patients some time and effort, since it allows for an easier IRB request and a shorter wait for a decision.

In practical terms, the new procedure presents itself as a carefully-worded check box on FDA Form 3926, the form for requesting access to an experimental treatment. If the physician checks the request in question 10.b, then the FDA’s approval of the 3926 includes approval of the request for a one-person IRB review.

Expanded Access Review Requirements

The policy change does have logic to it. The requirement for a full committee review stems from the need to consider a full-scale research program involving human subjects. An expanded access application is different: rather than satisfying research questions it aims to help patients gain access to a possibly helpful treatment. It seems reasonable then to consider a less bureaucratic and speedier avenue, such as this one-person review, to assess a request for expanded access.

 

Are Expanded Access Review Requirements Truly Improved?

Although the decision could save time and effort in the IRB review of an expanded access request, in reality, the expanded access review requirements and request process are already quite efficient. A General Accounting Office review recently concluded that the FDA’s expanded access program is generally effective and responsive, but also called for better communication regarding it. The FDA makes its expanded access decisions within days—sometimes within hours—and it approves the vast majority (99 percent) of the requests it receives.

The right to try laws and proposals aim to remove the FDA from the process of approving expanded use, but in practical terms that agency is not the primary obstacle. Historically, the sponsors of a particular research program have presented the largest challenge to expanded access requests. While proponents of Right to Try laws may seek to vilify the FDA as a bureaucratic barrier, this new exemption and other steps suggest the agency wants to find ways to make fair, sympathetic, and swift decisions.

Quorum Review IRB welcomes the FDA’s streamlined approach, and is prepared to review expanded access requests as quickly as possible. Our processes can accommodate the exemption of full board review, and we provide expanded use reviews without cost to the patient. Contact us if you need guidance or have any questions about review.