AOA files expansive FDA complaint against Opternative

FTC issues warning letters related to Contact Lens Rule

Repeated petitions for stricter enforcement of the Federal Trade Commission's (FTC's) Contact Lens Rule resulted in dozens of agency notices to potential violators, admonishing compliance or penalties.

Doctors must be in compliance with the law.

Issued to 55 contact lens sellers and prescribers last week, the FTC letters cite complaints that claim deficiencies in meeting Fairness to Contact Lens Consumers Act (FCLCA) and Contact Lens Rule requirements which grant patients the ability to comparison shop for contact lenses only in accordance with a valid prescription.

The FTC issued separate letters to sellers and prescribers, both stressing relevant portions of federal requirements and warning of legal action, including civil penalties up to $16,000 per violation. Prescribers' letters note that patients must receive their contact lens prescriptions post-fitting, free-of-charge or obligation. Similarly, sellers' letters note that contact lenses are restricted medical devices that require verification of a current, valid prescription prior to sale, and that sellers may only substitute prescribed lenses under certain conditions.

"A valid and verified prescription helps ensure that consumers have been examined for overall eye health and proper fitting by a licensed eye care professional," the sellers' FTC letter states. "Without guidance or supervision by a licensed eye care professional, consumers may develop serious injuries or complications from contact lenses."

Doctors must be in compliance with the law, and the AOA offers resources to assist members in meeting such requirements and ensuring contact lens sellers do, as well.

Crackdown on offending sellers
Online contact lens sellers sometimes employ business tactics that can mislead consumers or altogether sidestep the very FCLCA and Contact Lens Rule requirements designed to protect contact lens wearers. Therefore, the AOA has, and will continue, to urge the FTC to make prescription verification abuses by internet mass-retailers a top enforcement priority.

Just this past December, three dozen members of Congress signed a joint letter to the FTC, calling for the commission to do more to protect patients from seller abuses. Penned by Rep. Derek Kilmer (D-Washington), a member of the House Appropriations Committee, the letter stressed the need to curb these harmful business practices, saying: "In fact, tactics such as deceptively asserting the right to act as the patient's agent and failing to effectively communicate the need for appropriate physician oversight when using contact lenses poses a threat to public health and safety."

The Congressman's letter directly referred to action in September 2015 regarding 1-800 Contacts' use of a pre-checked authorization box (beneath users' browser windows) that was used to obtain patient agency for procuring a complete copy of their prescription. The AOA—hearing from doctors whose patients never intended to give 1-800 Contacts that authority—brought the issue to FTC officials. Subsequently, 1-800 Contacts' removed the pre-checked box and patients now have to actively select whether they would like the retailer to act as their agent to obtain prescriptions.

It's through doctors' vigilant reporting of such incidents that AOA has the ability to advocate for policies that better protect patients. The AOA asks doctors to help hold unscrupulous contact lens sellers accountable by alerting the AOA to all FCLCA violations, and documenting and reporting them to the FTC.

Please report any issues with contact lens sellers to AOA's Associate Director for Coding and Regulatory Policy, Kara Webb, at kcwebb@aoa.org, and also report through the FTC's online complaint system.

April 11, 2016

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