Value, Digital Health and Wellness Device Regs
Beth Luoma, an associate attorney with DuVal, writes the shift from fee-for-service to value-based care will continue. She says manufacturers are going to have to demonstrate that their value proposition “actually plays out” in “creating value-based arrangements with customers that appropriately share risk but fall within the current legal and regulatory framework for discounts and warranties under the Anti-kickback Statute.”
Digital Health, writes Lisa Pritchard, a regulatory, quality and compliance consultant, “is likely to see a radical innovation explosion in the coming months, particularly in the areas of mobile applications, artificial intelligence, augmented reality, and cloud-based processing.”
“The challenge will be in effectively partnering with FDA to manage the data expectations to allow these new types of products to efficiently make it to commercialization.”
The growth in the design and use of Mobile Medical Apps (MMA) will be a significant challenge for companies not typically used to interpreting medical device regulations. She adds that there will be a requirement for Quality Management Systems to ensure appropriate controls through the life cycle of product claims.
DuVal associate attorney, Aaron Hage, writes the 21st Century Cures Act and FDA’s Final Guidance, “General Wellness: Policy for Low Risk Devices” have provided a safe haven for products intended to only be used for general wellness purposes, and not for the cure, mitigation, treatment, or prevention of disease.
Manufacturers have taken advantage of this statutory exemption to create devices that allow people to take a more active role in their own wellness decisions. “However, many of these technologies have advanced to include diagnostic capabilities and claims, and thus have moved back into FDA’s realm of regulation and oversight.”
He warns the Agency may decide to step up its enforcement powers on those wellness products “that may meet the definition of a medical device but do not fit the defined boundaries of its enforcement discretion.” Manufacturers will have to decide if they want to stay on the wellness product side of the line and be safe from prosecution or decide to compete with more sophisticated technology and comply with regulations to have the marketing advantage of claiming FDA clearance or approval.
Commercial Speech and Marketing
The FDA is likely to pay closer attention to how product information is being communicated to audiences, states the DuVal note. If a company shares truthful scientific information not on the product’s label, that company and its employees have been subject to criminal prosecution.
Luckily, courts have stepped in to protect the right of sales reps and companies who share such information and the FDA has acknowledged there is a problem with their current position. But the issue remains unsettled.
DuVal writes the FDA will likely continue to struggle with the line of demarcation between its right and desire to review commercial speech and the constitutional limitations placed on the Agency’s authority by the First Amendment.
He expects that line to be tested and challenged by both FDA, industry, and various advocacy groups. “FDA will continue to struggle to find a proper balance between protecting patients and physicians from information that it has not reviewed and approved with the paternalistic temptation to suppress the free exchange of medical and scientific information, in whatever format or venue it is created and communicated.”
This will be an interesting year, concludes DuVal. “We’ll see if AdvaMed and MDMA [industry trade associations] protect the industry from debilitating change.”
