By: Nick Bonds, Esq.

Feeling under the weather? There’s an app for that. Sort of.

This is the future presaged by “PDURS” (Prescription Drug Use-Related Software). One of the sillier acronyms to grace the healthcare industry in recent memory, PDURS are defined by the FSDA 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.” Essentially, most patients will encounter this software as an app, paired with marquee prescription drugs, that is designed to “assist” patients and healthcare providers in the prescription and use of the medication.

The FDA is working to assume regulatory authority over PDURS and released draft regulations on PDURS in 2018. It also updated draft regulations in 2023 along with Draft Guidance outlining regulatory considerations for PDURS. Broadly speaking, the FDA’s guidance creates two primary categories of prescription drug labeling 1) FDA-required labeling and 2) promotional labeling. The FDA-required labeling is defined broadly to include any prescribing information, as well as any software output that “supplements, explains, or is otherwise textually related to one or more of the [manufacturer’s] drug products” constitutes labeling. In other words, virtually any type of PDURS app or software would be considered “labeling” and subject to the FDA’s authority. Alternatively, the FDA’s Draft Guidance reasons that PDURS may also be regulated as a medical device, or as a combination of labeling and device functions.

Ultimately, FDA regulations should be aimed at ensuring that PDURS are safe and reliable. The methodical pace of these regulations’ development and implementation may be slowing the rollout of PDURS apps for the moment, but they certainly aren’t stopping them. The FDA has already approved the launch of “Software-Enhanced Drug therapies” from Click Therapeutics and Otska Pharmaceutical that pairs with a six-week drug regimen to treat major depressive disorder.

Theoretically, PDURS will improve the effectiveness of medications by helping patients stay on track with taking their doses as directed, tracking and managing the patient’s condition and side effects, educating them more thoroughly about their prescription drugs, assisting in clinical decision-making, and helping tailor doses to the individual patient. That said, coupling an app with a prescription drug provides a new way for name-brand drug manufacturers to defend against generic equivalents. This could also “software-lock” patients into using a more expensive name brand drug, not unlike car manufacturers using software to require owners of their vehicles (the end users) to only have their maintenance done at authorized dealers and repair shops. Effectively, drug manufacturers could use the licensing arrangements of PDURS software to stifle competition from generic versions of their drugs, keeping the name-brand prices higher and keeping employees and their group health plans locked into paying them.

 

That’s all before even considering that PDURS apps and software will open yet another avenue for data mining and gathering other sensitive information about individuals and their health. As more of these PDURS proliferate, The Phia Group and all stakeholders in the self-funded industry will be keeping an eye on how they, and the guardrails around them, evolve.