FDA Digital Health Regulations Could Create New Opportunities for Pharma

New FDA regulations could create new opportunities for pharmaceutical companies.

Image: Pxhere

New and proposed FDA regulations could create new opportunities for pharmaceutical companies looking to develop digital tools, according to a new PricewaterhouseCoopers (PwC) report.

Within the last few years the FDA has made several changes in digital health regulations. Though many of these aren’t yet reinforced, a recent PwC report predicts that these changes could open new doors for pharma companies looking to jump into the digital arena.

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“Recent changes made by the FDA have made it easier for digital health products to be cleared and approved, offering life sciences companies – and pharmaceutical companies in particular – the opportunity to accelerate approvals and improve provider and patient satisfaction. Companies willing to invest in strengthening or building digital competencies may win market share, while those without sufficient investments may find themselves at a disadvantage,” the report said.

Image: Pxhere

Here are four major regulatory changes to digital health are driving new opportunities for pharma, according to PwC:

1. Digital Health Precertification. Pharma companies with high degrees of regulatory quality are eligible for shorter reviews and ONC certification.

2. Companion Applications. The FDA will allow digital apps intended to supplement prescription drugs to be regulated as labeling, meaning they will not require FDA approval.

3. Multiple-Function Devices. The FDA will treat as separate the various functions of a digital health device, making it easier to have full-function products.

4. OTC Drug Digital Labeling. Over the Counter (OTC) drugs may be approved based on evidence that consumers can use digital labeling to select a drug for treatment.

These regulatory changes can make it easier for pharma to go digital, and at the same time it could be an indicator of the future of the healthcare industry, reports MobiHealthNews.

However, authors of the PwC report continued to advise companies to implement digital into its existing portfolios and expertise.

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“New regulatory pathways will simplify market access and product development cycles, but companies will still need to take stock of how they can best leverage digital health with their new or existing product portfolios, and the data that will be necessary to support these products,” the report said.

Sam Draper
April 1, 2019

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