This week, FDA Commissioner Scott Gottlieb revealed a budget action plan filled with ambitious programs to modernize drug and device production, ways to implement innovation to the process and minimize costs and advance public health priorities in the process. Here’s a look at six of them.
Using clinical data to inform product reviews, from medical devices to biologics
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The FDA called for enlisting as many as 10 million electronic medical records and natural language processing to speed the regulator’s ability to address emerging safety concerns for drugs, biologics and medical devices. The regulator noted that it was already using clinical data to streamline post-market data collection, improve the way new devices are approved and to review new indications of already marketed drugs and devices, such as pacing leads, companion diagnostics, a spinal cord stimulator and a pediatric ventricular assist device. In the statement, the FDA said its approach could create a better way to inform patients and providers about pre-and post-market safety. It could also reduce some of the challenges to data collection for assessing safety and effectiveness for how these products are used.
Create a framework for post-market oversight for digital health
This framework dovetails with the FDA’s pre-certification pilot program currently underway. It speaks to an approach that focuses on validating the quality of a company’s software design and methods for certifying quality and reliability of software performance. It would focus on post-market collection of data to support new product functions and updates.
Establish Center of Excellence on Digital Health
Health Benefit Consultants, Share Your Expert Insights in Our Survey
Share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health, healthcare navigation, and more.
Cybersecurity is one of the driving forces behind the FDA’s interest in creating a center of excellence for digital health. So is creating the capacity to evaluate and recognize third-party certifiers. But it would also be designed to support the end goals of a more streamlined certification program for digital health tools.
…the current regulatory framework is not well-suited for driving the development of safer, more effective software-based devices, including the use of machine learning and artificial intelligence.
Advance small-footprint, high-technology manufacturing platforms
To support the development of immunotherapy and to make vaccines for pandemics more readily available on short notice, the FDA called for advancing drug and biological product manufacturing technologies. Continuous manufacturing is an example of the kind of approach that can drug and biologics development more flexible and cost-efficient. The agency wants to develop a science-based framework that includes guidance for how products developed in these systems would be evaluated, funding research, development and testing of the enabling technologies, to bring down “the cost and uncertainty of adopting these new manufacturing platforms,” the regulator’s statement said.
Create voluntary program for revamping device manufacturing
The word “modern” was used in the list of proposals nine times, including in reference to medical device manufacturing. The regulator would like to see a voluntary program to make the process for introducing a standardized process for making the introduction of innovative device production less cumbersome. The FDA explained the rationale behind the proposal:
As medical devices become more complex ? and given the frequent modifications made to devices — spurring advanced manufacturing and creating a competitive marketplace for device quality is critical for both driving technological innovations and assuring patient safety.
The regulator would like manufacturers to invest in their production facilities and in materials to achieve these innovations. The kinds of innovation in device production the FDA has in mind include: “automated processes that monitor and record manufacturing quality metrics, incorporating features and technological characteristics that can contribute to better options and higher quality that achieves their clinical purpose.” Also, the FDA said it would recognize third-party certifiers.
Modernize generic drug review
A critical stumbling block for the wider use of generic drugs, as the FDA sees it, is labeling. “If more generic drugs had up-to-date product labels reflecting the latest treatment information, it would encourage wider adoption of generic medicines,” the regulator reasoned. For product labels, oncology products would be the top priority. The goal is to provide the most up-to-date information so that clinicians and patients can make more informed choices.
Photo: Getty Images
