Federal regulators are confronting a new twist in drug development: manufacturers that include software with the medicine to prod patients to take pills as directed, manage side effects or track how well a treatment works.
Why it matters: The apps could boost the drugs' clinical value and provide a more personalized approach to managing chronic conditions such as depression, obesity and musculoskeletal problems. But the combinations are blurring the line between digital health and medicines and putting the Food and Drug Administration on the hook for making sure the software works and doesn't pose an increased risk to patient safety. The big picture: The FDA is fine-tuning guardrails that would allow software that guides treatment to be prescribed at the same time and appear on the same labels as drugs they accompany.
Prescription drug use-related software, or PDURS, has been on the agency's radar since 2017, when it rolled out a digital health plan to better address mobile medical apps, fitness trackers and software that aids clinical decisions. Guidance released last fall that's expected to be finalized within months lays out benchmarks for new products and what existing software may face reviews and potentially need to be upgraded. What they're saying: "FDA finds itself in this position a lot, where it's using a regulatory framework that certainly did not contemplate and is not designed to accommodate novel emerging technologies," said Emily Leongini, a partner at ArentFox Schiff.
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