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.
- “The progress we’ve seen in the five years since we released the framework is astonishing,” FDA Office of Medical Policy’s Evan Wearne said in an agency Q&A. “While some sponsors are adding software functions to existing therapies as an ‘optional tool,’ other sponsors are creating drugs with accompanying digital features to improve safety and efficacy.”
Zoom in: In April, the FDA approved an app from Click Therapeutics and Otsuka Pharmaceutical that’s meant to be used in tandem with drugs over six weeks to help treat major depressive disorder.
- It’s just one example of how the worlds of drugs and devices are converging, Click Therapeutics CEO David Klein told Axios. “Software solutions can fill some very important gaps,” Klein said.
- PDURS can help patients with rare diseases who have complex drug regimens make sure they take their drugs on time, or help patients on blood pressure medication more closely monitor side effects to work with their doctor and optimize their dose, said Andy Molnar, CEO of the Digital Therapeutics Alliance.
- In the case of GLP-1 drugs like Wegovy or Zepbound, it could reduce the odds of patients stopping the meds early due to side effects, and help them reduce muscle loss.
- “You need to know, like when a side effect is something that you need to go to the hospital for and when it’s no big deal,” Molnar said.
Between the lines: Pairing a software with a drug can influence doctors’ prescribing practices — and how insurers ultimately reimburse. It also could help brand-name drugmakers differentiate their products from generic competitors.
- Among the questions FDA has grappled with is when would software be considered promotional labeling.
- New standards could, however, differentiate approved apps from ones that make unsupported treatment claims.
- “I see a world coming quickly where software-enhanced versions of these drugs capture significant market share and forces the rest of the world to catch up,” Klein said.
Yes, but: In comments to the FDA, pharmaceutical trade groups like PhRMA and BIO called for the FDA to hold digital therapeutics that might pair with drugs to the same sorts of standards a drug might face.
- And while payers are beginning to become more open to reimbursement for clinically validated digital therapeutics, they are closely scrutinizing this area, said Otsuka CEO Tarek Rabah.
- “Like any new treatments, they would like to see and understand it a bit more,” Rabah said. “How would this benefit the patient and what does this mean to the overall cost management that they are actually deploying?”
What to watch: What drugs become candidates for a software boost.
- “Within the next couple years, every pharma company is going to have to make a PDURS decision on every molecule that they have,” Molnar said.