Last month, the U.S. Food and Drug Administration (FDA) released the names of nine companies which have been selected to participate in the pilot version of their Digital Health Software Pre Certification (PreCert) program. The list includes market giants such as Apple, Samsung, Johnson & Johnson and Fitbit.
PreCert has been described as a sort of TSA pre-check for trusted companies, allowing them to get new products passed through the FDA process on a fast-track basis, and even to skip the approvals process altogether in certain cases.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” Scott Gottlieb, commissioner of the FDA, said.
It was about time that the FDA stop treating the new FitBit model with the same level of background check scrutiny as an MRI machine. However, consumers should consider the risk versus reward of the leniency and favoritism the program may introduce into the FDA approvals process.
Although I know that the FDA plans to extend their list
of approved companies after the initial nine of the pilot program, I can’t help but express concern over the idea that it is the companies, and not the products themselves, that the FDA is shifting their focus to approving.
Already, the FDA demonstrated the impact this can have on smaller startups with 23andme two years ago. The then newer, lesser-known company had developed a product which gave customers genetic information about their risk for diseases and conditions. However, this was then taken off the American market for two years while the FDA put it through a “streamlined” approvals process, from which the product emerged less effective in catching risk factors and more expensive for consumers.
Granting the FDA the ability to pick and choose companies, rather than products, allows big-name companies like Apple to quickly introduce a potentially unsafe product, while smaller companies and startups are inhibited by the bureaucracy.
Additionally, I think that while the FDA’s response maybe appropriate in today’s culture, it may not hold up in the long-term, as we shift healthcare out of the hands of professional clinics and into our own hands and devices. Currently, most users take the data given to them by at-home devices, such as the Apple Health app, with a grain of salt, knowing that it’s information is intended to supplement, rather than replace, traditional healthcare. However, due to the expected increase in reliance on these technologies, we need to keep in mind that their accuracies and strength of treatment need to be just as strong as those provided by professional machinery found in doctor’s offices and hospitals today.
We should be a bit wary of the FDA’s new PreCert program, and not hesitate to be critical as they proceed with their pilot program.
Image: Andri Koolme