FDA Issues Request for Comment on New Framework for Prescription Drug Software Applications

Recently, the US Food and Drug Administration (FDA) issued a request for comment that sets forth a proposal for a new framework on the regulation of software applications for use with one or more prescription drug products. The proposal follows Commissioner Scott Gottlieb’s promise to establish a new approach to FDA’s regulation of digital health tools, but addresses only a subset of such tools.

FDA Working to Support Digital Health

The newly proposed framework coincides with an agency-wide shift to support digital health. The work—fueled by recent legislative actions seeking to modernize the care delivery system through greater adoption of emerging technologies for targeted therapies—are largely aimed at making the rapidly growing body of real world data (RWD) more robust to ultimately increase the use of real world evidence (RWE) that can support decision-making on FDA-regulated medical products.

The Framework focuses on the use of RWE to support regulatory decisions about effectiveness. The agency outlines three considerations that will guide its overall RWE Program and inform the agency’s assessment of individual drug applications. The Framework also offers background on the agency’s previous use and current initiatives with respect to RWE and related topics, such as innovative clinical trial designs.

In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using RWD and RWE to enhance regulatory decision-making and noted that leveraging this information is “a top strategic priority for the FDA.”  FDA opened a docket for public comments on the Framework through February 5, 2019.

Highlights

Attorneys at Arnold & Porter point out three major highlights from the framework:

• FDA would regulate drug-use-related software “output” as drug labeling. Under the proposed framework, software “output” would be regulated as drug labeling. As such, the framework distinguishes output that would be classified as “FDA-required labeling,” which requires approval prior to dissemination, from output that is characterized as “promotional labeling.” Promotional labeling must be submitted to FDA at the time of initial dissemination of the promotional materials (with the exception of accelerated approval drugs subject to special provisions on submission prior to use). Under some circumstances, however, the framework recommends that promotional software output be submitted for pre-dissemination review under the Agency’s existing voluntary process for requesting advisory comments where it may increase the potential for harm to patients compared to the use of the drug without such output.

• The framework does not address precisely when prescription drug-use-related software is considered a device but—not surprisingly—contemplates overlap between software outputs and medical device regulatory requirements. The focus of the proposed framework is not on when prescription drug-use-related software is considered a device, and it does not propose to alter the regulatory framework for such devices. However, FDA anticipates overlap between this proposed framework regulating software output and device regulation, for instance, in the case of combination products.
• The framework distinguishes between software disseminated by drug sponsors versus independent third-parties. The proposed framework is only intended to apply to software disseminated by, or on behalf of, a drug sponsor for the use with one or more of the sponsor’s prescription drugs. Other software disseminated by third parties unaffiliated with a drug sponsor would not fall under the purview of this framework, even if the intention of the software is for it to be used in conjunction with a particular prescription drug and the third-party software meets the definition of a device. Such software would be regulated under existing device authorities, to the extent applicable. However, where a drug sponsor licenses software originally developed or disseminated by a third party and then disseminates the software for use in conjunction with the sponsor’s prescription drug, the software would then fall under the purview of the proposed framework.