Regulatory barriers are stifling the contact lens industry

In the science fiction novel Rainbow’s End, contact lenses equipped with what we would now call “augmented reality” allow wearers to overlay different images, filters or virtual scenes on top of real-world sites. 

In fact, such breakthroughs might not be that far off. Samsung currently is working to produce lenses equipped with cameras and sensors to create better augmented reality experiences than are possible with current mobile apps or headset-based augmented reality products like the Microsoft Hololens. In the near future, “smart” contact lenses also will be available that allow diabetics to monitor their glucose levels or that autofocus to correct age-related sight issues.

{mosads}Unfortunately, whether the more than 40 million Americans who wear contacts will be able to access these breakthroughs easily and affordably is a more difficult question to answer. Throughout the contact lens industry, protectionism and barriers to experimentation threaten to stall innovation.

In fact, pioneers in smart-contact technologies already are pushing back their release dates. Autofocusing lenses developed by Novartis in partnership with Google originally were slated to begin clinical trials in 2016. The process is delayed into the unforeseeable future. Other smart-contact applications remain glints in their inventors’ eyes.

The U.S. Food and Drug Administration regulates contact lenses as medical devices. Given the regulatory uncertainty, complexity, cost and length of the FDA medical-device approval process, companies are discouraged from investing in smart lens development. The average cost to bring a low-to-moderate risk medical device to market is $31 million, 77 percent of which goes towards FDA-related activities. A Stanford University report surveying U.S. companies found the average time from first communication until FDA clearance was two and a half years, compared to just seven months for the review process in the European Union.

In addition to these barriers to innovation, the contact-lens industry is rife with protectionism. Despite a Federal Trade Commission regulation promulgated more than a decade ago requiring prescribers to give consumers copies of their prescriptions, there is evidence of widespread flouting of the rule. In April 2016, the FTC issued 45 warning letters to prescribers and 10 more to retailers about alleged violations of the rule’s verification clause. The obvious motivation for such violations is to force consumers to buy from outlets owned by or affiliated with their prescriber, shutting down other sources of competition. This intransigence notwithstanding, the rule largely has proven to be a success, with prescribers’ market share falling from nearly 69 percent to roughly 40 percent in the decade after its enactment. 

But traditional eye-care providers continue to lobby to restrict online sales, citing fears about the safety of online markets and of nontraditional or cosmetic lenses. Contact lens wearers do sometimes injure themselves, but research clearly shows these case overwhelmingly are attributable to user error – to bad hygiene decisions like wearing lenses overnight, exposing them to tap water or reusing lens solution. A study by the FTC found such harms were not correlated with the type of contacts a user bought, whether they were issued pursuant to a prescription or the manner in which they were sold. Online contact sales are no more dangerous than those made in person.

Rather than the current command-and-control approval process, the FDA should move toward a more permissive regime that encourages innovation. It could consult with industry to develop best practices and guidelines for safety, cybersecurity and privacy in the smart contact lens market. If policymakers do not address the barriers to develop and market these tremendous breakthroughs in smart lenses, the competitive edge the United States has enjoyed thus far in wearable technology could disappear in the blink of an eye.

Anne Hobson (@AnneLHobson) is a technology policy fellow with the R Street Institute (@RSI).

The views expressed by contributors are their own and are not the views of The Hill.