Given the early arrival of Thanksgiving this year, it should have been a long shopping season, but the walls are already closing in. The days are still growing shorter. The trees and decorations have gone up. We are all in earnest.
In the meantime, Commissioner Gottlieb continues to make liberal use of special statements issued by FDA, one of which will be the sole focus of the Roundup. Next week I hope to get in an intervening posting as well.
- Digital Health Gets Coordinated – This week Commissioner Gottlieb put together a special statement that pulled together focus on all that the agency has been doing to define the digital health space from a regulatory point of view. FDA announced the issuance of three policy documents – two draft guidances and one final – to add more body to the understanding to the agency’s approach. The statement is clearly meant not only to package all that the agency is doing in digital health, and to signal progress under the 21st Century Cures Act, but also to signal to policymakers that FDA is not standing in the way of progress with regulation, but using judicious regulation to enhance progress. In doing so, referencing a starting point with this summer’s Digital Health Innovation Action Plan and the launch of the digital health software pre-certification program, he outlined the three guidance documents.
- The first – Clinical and Patient Decision Support Software – relies on the tenet that FDA should concentrate its resources on regulating that which has a higher risk associated with it rather than take an across-the-board tack of regulating everything that touches a patient in any capacity. Accordingly for both clinical and patient oriented software programs, FDA will regard as medical devices (and therefore under regulation) only those that process are involved in analyzing or processing clinical aspects of care, such as a blood analysis, while leaving outside the agency’s jurisdiction those that provide information within established clinical guidelines within approved labeling for a drug. In the statement, FDA uses an example software that might trigger a physician to order liver function testing before prescribing a statin. In short, more information oriented software will be outside FDA purview, while functional software with a clinical impact will be inside.
- The second draft guidance takes action to clarify the agency’s position on digital health devices that again play a low risk role – such as mobile apps that are intended only for maintaining a healthy lifestyle and not involved in clinical decision-making. Previously FDA had said it would exercise its discretion on enforcement, but with this draft guidance FDA indicates that such devices will fall outside the scope of FDA’s regulation.
- Finally, the third guidance is one meant to harmonize the FDA approach to digital health with the agency’s global counterparts to enhance the use of products across borders and is being issued as a final guidance, having been initially issued in October 2016.
The statement closes by saying that the agency is attempting to establish the bright line between what requires and does not require FDA review and regulation. Given that two of these documents are draft, there is time to provide in put into the definition of that bright line.
Upcoming Events to Keep an Eye on This Week
- Senate HELP Full Committee Hearing – The Cost of Prescription Drugs: An Examination of the National Academies of Sciences, Engineering and Medicine Report – “Making Medicines Affordable – A National Imperative” – On Tuesday, December 12.
- House Energy and Commerce Committee – Oversights and Investigations – Examining Concerns of Patient Brokering and Addiction Treatment Fraud – On Tuesday, December 12.
- House Energy and Commerce Committee – Subcommittee on Health – Examining the Drug Supply Chain – On Wednesday, December 13.
Regulatory Developments in Pharma/Biotech/Devices
- FDA Approves Once Weekly Diabetes Treatment
- FDA Provides Guidance on 3D Printing of Medical Products
- Remarks of FDA Chief Counsel at FDLI Enforcement, Litigation and Compliance Conference
That’s it for me this week. Have a good weekend and get some shopping done!
Photograph by Lynne Bertram
