On Tuesday, November 20th, FDA announced the establishment of a public docket to solicit comments and feedback on a proposed framework regarding the regulation of prescription drug-use-related software applications. In a recent Federal Register notice, the Agency defines prescription drug-use-related software as “software disseminated by or on behalf of a drug sponsor that accompanies one or more of the sponsor's prescription drugs (including biological drug products).”
During the Reagan Udall Foundation annual public meeting, FDA Commissioner, Scott Gottlieb, MD, made a few remarks in which the innovation of medical technologies was addressed. With the creation of over 150,000 mobile health apps over the past three years, regulation on drug related software must be comprehensive. Dr. Gottlieb went on to say that the FDA will “never fully realize the potential for digital tools to improve health until we adopt an efficient framework for integrating apps and software into drug development, review, and product approval.” This prompted the imminent need for feedback on the proposed framework.
The purpose of the framework being proposed is to clearly differentiate between the following:
Dr. Gottlieb notes that, under this framework, most apps would not be required to undertake pre-market review, instead of “the software output—screen displays or audio messages—would be considered promotional drug labeling,” which is one of the two categories the FDA identifies for drug labeling.
FDA-required labeling is labeling which is drafted by the manufacturer and “includes information that is essential for a provider to make an informed decision about the risks and benefits of prescribing the drug for a patient and the information needed to safely and effectively use the drug.” This can include, but is not limited to, prescribing information, medication guides, or instructions for use. FDA-required labeling is reviewed by the Agency as part of a new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA). Furthermore, FDA must also review and approve nearly all changes made to these labels.
Promotional labeling includes any labeling [other than FDA-required labeling] that does not pertain to patient safety and is instead formulated for the product’s promotion. Promotional labeling may serve other roles in addition to promotion and “can include publication of printed, audio, or visual matter descriptive of a drug that is disseminated by or on behalf of a drug's manufacturer, packer, or distributor”. Once the sponsor disseminates the app, its output needs to be submitted to the FDA’s Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB). Sponsors may opt to receive comments from the Agency before dissemination after they submit to the APLB or OPDP, however, most do not ask for review. In 2017, over 100,000 promotional pieces were submitted to OPDP.
If finalized, FDA hopes the proposed framework will help to encourage the development of innovative digital health applications among drug makers. However, the Agency clearly states that the framework only applies to apps shared by prescription drug sponsors and is NOT applicable to those created by third party developers.
The Agency’s proposal to categorize software output as promotional labeling is consistent with the regulatory framework set forth in the 21st Century Cures Act, which outlines what is considered a medical device. The Cures Act amended the FD&C Act by excluding certain software outputs from the statutory device definition. The aim of the FDA is to “pursue a risk-based and least burdensome approach to these products to promote beneficial innovation that can promote healthcare goals and advance patient health and safety.”
In his speech, Dr. Gottlieb requested that “some of the same approaches to apps that are coupled to drugs”, be applied to software as a medical device (SaMD). This is not the first display of support of digital health by the FDA. In April of this year at the Health Datapalooza conference, the FDA conveyed its dedication to digital health though the introduction of multiple programs and drafted policies. All of these programs are coinciding with recent legislative actions that aim “to modernize the care delivery system through greater adoption of emerging technologies for targeted therapies”. The FDA’s Center for Devices and Radiological Health (CDRH) facilitates medical device innovation. They collaborate with the International Medical Device Regulators Forum (IMDRG) to create a new Pre-Certification program for software that will remove regulation barriers and fast track products.
The FDA hopes that the framework will define a more effective pathway for the development of digital tools. With this new approach to software products, the FDA will look to implement the changes across the entire agency. The FDA will be considering and weighing all comments as the draft guidance is being developed. Comments can be submitted in written or electronic format and must be received by January 19, 2019.
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