The Food and Drug Administration (FDA) recently published a Notice and Request for Comments regarding a potential proposal to impose less stringent regulations on biopharmaceutical software applications (“pharma apps”), signifying an area of growth for digital health technology. In its Notice published on November 20, 2018, the FDA will regulate prescription drug use related software as promotional material so long as the company does not intend to claim that such software is necessary for the safe and effective use of a product, which would traditionally require full premarket approval (PMA) from the FDA. Though the FDA will require the submission and review of the promotional material at the time of initial dissemination, the FDA will largely not require approval or clearance, thus significantly reducing the FDA’s level of review required by the current 180 day PMA review process and uncertainty over whether the approval will be granted. The proposed promotional review process will save biopharma companies both time and money.
In relation to the proposed regulation of prescription drug use related software, FDA Commissioner Dr. Scott Gottlieb stated“[t]he technology is ubiquitous, and I think this industry’s been slow to leverage it in large measure because of the regulatory uncertainty.” The FDA’s proposal establishes a much clearer pathway for drug companies to take advantage of certain branded prescription drug-use-related software and create pharma apps for patients through the shortened promotional review process. Comments can be sent to the FDAby January 22, 2019.