- Federal regulators may sanction the developer of an ocular telehealth platform over charges the company hasn’t received the necessary approvals to offer the online eye exams.
In a letter dated Oct. 30, 2017 and made public this past week, the U.S. Food and Drug Administration came down hard on Chicago-based Opternative, saying its telehealth platform has not received federal approval under the Federal Food, Drug and Cosmetic Act.
The letter, issued to Opternative CEO Aaron Dallek, makes several charges:
“FDA has reviewed your website and determined that the On-Line Opternative Eye Examination Mobile Medical App device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g),” it states. “The On-Line Opternative Eye Examination Mobile Medical App Device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b).”
The letter asks that Opternative “immediately cease activities that result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device, such as the commercial distribution of the device through your online website.”
An Opternative spokesman said the company has “responded to the Warning Letter” and is “working closely with the FDA on this matter.”
Opternative is one of several companies clashing with officials in several states over the reliability of ocular telehealth platforms for prescribing glasses and contact lenses. The company recently appealed a lawsuit filed against South Carolina’s Eye Care Consumer Protection Law, which a U.S. District Court judge had tossed out.
South Carolina is one of 12 states that currently prohibit the use of telehealth or telemedicine in eye exams. The others are Arkansas, Delaware, Georgia, Indiana, Louisiana, Maryland, Michigan, New Jersey, Oklahoma, West Virginia and the District of Columbia. Washington and Kentucky are considering legislation banning the online platform, and Connecticut passed a compromise bill allowing ocular telehealth after an initial in-person exam.
In Washington, the Federal Trade Commission issued a letter last month criticizing the state’s efforts to restrict ocular telehealth.
In an 11-page letter to State Rep. Paul Graves, The FTC argues that the proposed bill would unfairly restrict the consumer’s ability to access eye care services and raise the cost of eyeglasses and contact lenses. It would also, the agency said, mandate a comprehensive eye exam regardless of whether one is needed, and “could override the judgment of a vision care provider who otherwise would have concluded that the standard of care could be met with more limited services, either in-person, or if allowed, by telehealth.”
“By requiring an in-person, comprehensive eye examination for all corrective lens prescriptions, the Bill would restrict the use of innovative telehealth eye care technologies, and also could require examinations that are more extensive and costly than necessary,” the FTC said.
The FDA’s warning to Opternative drew praise from the American Optometric Association, which has long questioned the safety and reliability of online eye exams.
“The FDA’s enforcement action against Opternative is a major victory for public health and for the tens of millions of Americans who need and deserve access to quality care to safeguard their health and vision,” Christopher Quinn, OD, president of the 37,000-member organization, said in a statement. “The AOA and our member doctors across the country are gratified that the FDA has taken such decisive action to address the urgent health and safety violations we identified, reported and relentlessly follow-up on. It is our hope that we are a step closer to holding all companies that would place profits ahead of patient care fully accountable for their actions.”
Quinn noted the AOA has been targeting Opternative’s business model for at least two years.
“As a consistent advocate in ensuring that patients have access to medically-recognized eye healthcare and to protect patients from companies, platforms or services that may put their health at risk, the AOA filed a detailed complaint in 2016 exposing Opternative’s ‘vision test,’” he said. “The AOA outlined for the agency potentially serious health risks and documented the company’s non-compliance with Federal medical device and patient safety laws. The AOA also described a persistent effort by online vision tests to evade federal oversight and regulation, as well as continued, deceptive marketing tactics that misled patients and potentially jeopardize their eye and vision health.”
Those supporting ocular telehealth, including Opternative, recently launched Americans for Vision Care Innovation, a collection of more than a dozen advocacy groups, research organizations and online eye care vendors formed to “encourage states to adopt legislation allowing vision care telehealth services, including online vision testing and online prescription renewal for glasses and contact lens wearers, and to end restrictions on such services where they exist … (and to) fight against legislation that would roll back access to online vision care services in the states where it is currently allowed.”
“Online vision care services have the potential to produce significant savings for taxpayers,” Pete Sepp, President of National Taxpayers Union, said in a press release. “State and federal governments pay millions of dollars annually for eye care services for government employees and for Americans who receive benefits under government-funded health insurance and other programs. These costs can be substantially reduced if covered individuals have access to online vision care.”