Pharma to benefit from FDA digital health regulations

Companies that invest heavily now stand to steal a lasting lead over rivals that hesitate…


The Food and Drug Administration‘s approach to digital health is making it easier to get new products to market, creating opportunities for pharma companies to muscle in on new territory, according to PwC.

Analysts at PwC think pharma companies are particularly well placed to benefit from FDA’s changes, although they acknowledge medtech players already have the software and device know-how needed to seize the opportunities. They said companies that invest heavily in the space now stand to steal a lasting lead over rivals that hesitate.

The PwC report Acceleration by regulation: Pharma stands to benefit from the FDA’s new digital health approach highlights four changes to the regulation of digital health that have opened the door to greater participation by pharma companies. FDA’s digital health pre-certification programme tops the list on the grounds that it opens a fast track to market for companies with robust quality cultures.

PwC also highlights FDA guidance on multi-function devices, changes to the labelling of companion applications and a new approach to over-the-counter drug approvals as significant shifts.

In July 2018 the FDA published draft guidance that suggested approval of OTC drugs could be supported by labelling that contains a digital application.

“Under the FDA’s approach, these digital tools – primarily mobile applications – would help consumers choose OTC drugs that would be best for them and avoid drugs that could harm them,” PwC said.

The analysts argue the regulatory changes create particular opportunities for drug companies, potentially driving sales of their core therapeutics and moving into adjacent areas with shorter paths to market. Companies will need rigorous evidence to win over physicians, though.

“It’s all about the research,” Eric Topol, executive vice president of the Scripps Research Translational Institute, told PwC’s Health Research Institute. “Pharmaceutical companies need their digital health products to be supported by published evidence so that physicians and patients can look at it and be confident that the application or sensor works in the real world.”

Currently, some digital health organisations are failing to generate the evidence demanded by physicians. A paper published in the journal Health Affairs found almost half of the 20 best-funded digital health companies lack any peer-reviewed evidence of the performance of their products.

These specialists risk being overtaken by pharma companies and other organisations that are better equipped to scientifically validate their products. Traditional pharma companies, however, lack the culture of coding and software quality needed to succeed in digital health. PwC thinks companies must invest to create that culture.

Medtech companies are ahead of their pharma peers in that regard. Having incorporated software into their devices for years, device manufacturers have already invested in that side of their businesses.