How Has the Fairness to Contact Lens Consumers Act of 2003 (FCLCA) Benefitted Consumers?

Since the FCLCA became law in 2003, consumers have had the right to shop around when buying contact lenses. The law has increased competition among contact lens retailers, providing consumers with more choice, greater convenience and lower prices.

• The FCLCA has succeeded in saving consumers time and money, making it easier for them to replace contact lenses.
• It helps promote eye health by ensuring consumers have access to clean, fresh lenses at an affordable price.
• It represents a balance between the interests of consumers and stakeholders.

The FCLCA was intended to address anti-competitive practices that had emerged in a contact lens market uniquely saddled with conflicts of interests.

• Unlike most other medical professionals, optometrists are allowed to sell the very products they prescribe and many are also retailers of contact lenses. Optometrists make about 60% of their revenue from selling glasses and contact lenses.
• To add to that conflict, patients cannot choose the brand of contact lenses they wish to wear because their eye care providers’ prescriptions are brand-specific.

To help ameliorate the negative impacts of these conflicts on consumers, the FCLCA requires optometrists to provide their patients with a copy of their prescription without having to ask.

• Patients then have the option of using that prescription to purchase their contact lenses from their retailer of choice.
• If they choose a retailer other than their optometrist, and they don’t have a copy of their prescription, this alternative retailer then verifies the prescription by contacting the prescriber.
• The prescriber has eight business hours to respond. If the prescriber does not respond within the required time, the prescription is verified automatically, known as “passive verification,” and the retailer may provide contact lenses to the consumer.

Congress adopted this system after receiving evidence of widespread refusals by prescribers to verify prescriptions in the hopes of preventing their patients from buying their lenses from other retailers.

What are Some Examples of Efforts by the AOA and Manufacturers to Increase Their Own Profits at the Expense of Patients?

The AOA and manufacturers have a long history of efforts to control the contact lens market and increase their own profits at the expense of patients.

For decades, state and federal governments have wrestled with how to protect patients, promote competition and prevent industry participants from exploiting the prescription requirement.

In 1994, 32 state Attorneys General brought an MDL (multi-district litigation) alleging collusion between eye doctors and manufacturers – that they conspired to prevent the release of contact lens prescriptions to consumers, and to eliminate sales of contact lenses by pharmacies, mail order, and other alternative retailers.

• The defendants settled and had to pay over $90 million in financial penalties, with the manufacturers also agreeing to sell their lenses through alternative retailers, and the AOA agreeing not to make health claims based on where the patient purchases lenses.

In 2003, Congress enacted the FCLCA which guarantees consumers an automatic right to copies of their prescription and the right to have their prescriptions verified when they purchase their lenses from somewhere other than their eye care provider.

In 2005 and 2006, in response to the FCLCA, practitioners shifted to prescribing brands of lenses available only through eye care professionals (ECPs).

• Legislation was introduced in the House and Senate, and passed by the Senate, to effectively ban these restricted distribution practices.
• After a House hearing shed public light on the issue, manufacturers dropped the practice.

Starting in 2014, all four major contact lens manufacturers—Johnson & Johnson, Alcon, Bausch & Lomb, and Cooper Vision—began engaging in an anti-competitive price fixing policy known as a Unilateral Pricing Policy (UPP), where they forced retailers to sell lenses at higher prices. Members of the Coalition for Contact Lens Consumer Choice have been actively fighting these UPP’s on behalf of consumers.

• These regimes are designed to protect prescribers from encroachment of their retail businesses by artificially controlling price competition from alternative channels.
• The former President of Johnson & Johnson Vision Care said “This [pricing model] gives the optometrist the ability to improve his or her capture rate in the office. Now the patient has no incentive to shop around.”
• The Senate Judiciary Antitrust Subcommittee held hearings on these policies in July, 2014.
• These polices are the focus of active antitrust investigations by multiple state Attorneys General and have drawn harsh criticism from independent entities such as Consumers Union and the American Antitrust Institute.
• In March 2016, the Attorney General of Maryland filed a suit vs. Johnson & Johnson Vision Care alleging violations of state antitrust laws.
• In April 2016, Johnson & Johnson announced that it was discontinuing its UPP.
• In April 2017, Johnson & Johnson settled its antitrust suit with Maryland, agreeing to permanently abandon its UPP agreements and pay a $50,000 fine to the state.

In 2016, the AOA and manufacturers tried to push through legislation , the misleadingly-named Contact Lens Consumer Health Protection Act, that would have reversed the hard-fought gains in the FCLCA and limited the ability of consumers to conveniently access affordable lenses. Fortunately, the legislation was dropped after objections were raised by the Coalition for Contact Lens Consumer Choice and other consumer and good government advocates.

How Have Some Optometrists Failed to Comply With the FCLCA?

Federal law requires optometrists to automatically release contact lens prescriptions to patients following a contact lens fitting, whether or not the individual asks for it.

Despite this clear legal requirement, at least 30% of patients are never provided with a copy of their prescription, according to a 2017 survey conducted by Consumer Action. That translates into roughly 10-12 million patients each year not receiving their prescription. And the FTC has concluded that the overall non-compliance rate is actually between 56%-65%.

According to another survey, due to prescriber noncompliance, 29% of contact lens wearers (11 million) had to ask for a copy of their prescription after their last eye exam.

Results of a prescriber survey published in Contact Lens Spectrum Magazine in 2008 indicated that 50% of prescribers self-reported as not releasing prescriptions as required by the FCLCA.

Other survey evidence shows that contact lens consumers perceive that it is twice as difficult to get a prescription from their eye care professional as from their primary care physician.

In over 180,000 occurrences each year, prescribers provide false information in response to a verification request, by, for example, claiming that a valid prescription has expired, or providing insufficient information when stating a prescription is inaccurate or invalid.

Prescribers also try to thwart the process by hanging up on verification calls, requiring three or more additional follow up calls until the verification process can be completed.

Prescribers often employ these tactics to give themselves time to contact the patient in an attempt to make the contact lens sale themselves.

Why Are the American Optometric Association’s Claims About Health Dangers from Alternative Retailers Wrong?  

In an effort to increase profits from contact lens sales for optometrists, the American Optometric Association has made claims about the supposed health dangers from purchasing contact lens from alternative retailers. These claims have been thoroughly and repeatedly debunked.

FTC Found No Evidence to Support Health Claims

In its November 2016 proposal to update the Contact Lens Rule, the Federal Trade Commission (FTC) concluded that they saw no increased risk from buying contact lenses from alternative retailers, stating: “the Commission has not seen reliable empirical evidence to support a finding that such sales are contributing to an increased incidence, or increased risk, of contact lens-related eye problems.”

AOA’s Own Research Found No Link Between Health Risks and Location of Purchase

In 2016, the American Academy of Optometry (AAO) published a study in the medical journal Contact Lens & Anterior Eye titled: “Is Purchasing Lenses from the Prescriber Associated with Better Soft Lens Wearer Habits?” According to the study abstract, the study concludes that: “the purchase location of soft contact lens wearers had limited impact on known risk factors for soft contact lens-related complications… Closer access to the eye care provider through in-office soft contact lens purchase did not improve soft contact lens habits or reduce the prevalence of risk behaviors.”

Notably, this study, using Centers for Disease Control and Prevention (CDC) data, was conducted by the CLAY Group, an optometric research organization formed by the AAO and the AOA, and funded by a grant from Alcon, a leading contact lens manufacturer. It is therefore clear that the AOA and manufacturers continue to make unsubstantiated health claims that are not backed up by their own research.

Numerous Other Medical Studies Have Similarly Found No Basis for Health Claims

A CDC report from 2015 included a long list of risk behaviors for contact lens-related eye infections including overnight wear, but made no mention of where the lenses were purchased.

A study published in 2012 in the medical journal Eye found no difference in the incidence of keratitis, a leading indicator of bad eye health, between countries that require a prescription to purchase contact lenses and those that do not.

A study published in 2007 in the medical journal Eye Contact Lens also found no increase in the incidence of keratitis since the advent of online sales or since the adoption of the passive verification system under the Fairness to Contact Lens Consumers Act of 2003. The study further found no significant difference in the incidence of keratitis from one country to another, regardless of the varying extent of online sales in those countries.

Attorneys General Called on AOA to Stop Making Unsubstantiated Health Claims

In support of the landmark Fairness to Contact Lens Consumers Act of 2003 (FCLCA), the Chair of the Contact Lens Working Group of the National Association of Attorneys General Antitrust Task Force testified that the AOA’s health claims had no evidentiary basis and did not justify restraining consumer choice.

As part of the settlement to the Attorneys General lawsuit, the AOA had to agree to stop making health claims based on where consumers purchased their lenses.

Online Consumers Have About Same Levels of Compliance with Wear Guidelines

Online contact lens consumers and those purchasing lenses through their eye care provider report about the same levels of compliance with manufacturer and CDC suggested guidelines for healthy contact lens wear. Studies also show that patients who purchase their contact lenses online see their eye care provider at about the same rate as those who purchase their lenses through their eye care provider. Consumers are more likely to wear clean, fresh lenses when they are conveniently purchased and affordable.

Countries Allowing Purchase of Lenses Without a Prescription See No Health Effect

In almost all of the European Union, consumers may purchase contact lenses without a prescription. As noted above, medical research finds no difference in the incidence of keratitis between countries that require a prescription to purchase contact lenses and those that do not.

Purchase of Lenses with Expired Prescriptions is Rare

The purchase of contact lenses by consumers with expired prescriptions is uncommon and does not vary based on the place of purchase. In fact, consumers who purchase lenses through their optometrist, who originates the prescription and sets its expiration date, report using an expired prescription at a slightly higher rate (10%) than those who purchase online (9%).

Importantly, when verifying a prescription for a retailer, it is the optometrist’s responsibility to confirm that a prescription has not expired. In its proposed update to the Contact Lens Rule, the FTC noted that “prescribers are already in possession of the expiration date, and it is in their economic and professional interest to check the prescriptions and respond to verification requests by informing the seller whenever a prescription has expired.”

Are There Eye Care Professionals Who Oppose the CLCHPA?

The National Association of Optometrists and Opticians (NAOO), the trade association representing the retail optical industry, which includes eye care professionals who do not profit from selling what they prescribe, issued a letter to Congressional leaders stating its strong opposition to the CLCHPA. In its April 18, 2016 letter, the NAOO states:

“This ill-conceived legislation would roll back the clock to a time before consumers enjoyed the convenience, choice and benefits of price competition provided by a robust, competitive contact lens marketplace….

“S. 2777 is not, as suggested by its supporters, about any legitimate patient health concerns. It is simply an effort to gut the main provisions of the highly successful, bipartisan 2003 Fairness to Contact Lens Consumers Act (the FCLCA)….

“S.2777 is simply the latest in a long line of seemingly never-ending attempts to undermine the FCLCA. It is an anticompetitive approach that was soundly rejected by Congress in the past and should be rejected again. It is an attempt by legislative fiat to take money from the pockets of consumers and move it onto the balance sheets of those optometrist for whom retail sales of glasses and lenses – rather than providing eye health services – is the primary income driver. It would deprive consumers of choice and convenience, and raise contact lens prices.

“NAOO urges you to stand up for consumers and oppose S. 2777 in the strongest possible terms.”

Why did the Coalition for Contact Lens Consumer Choice Oppose the Contact Lens Consumer Health Protection Act of 2016 (CLCHPA)?

Depending upon their role in the community and the economy, Coalition members have a variety of reasons for opposing CLCHPA:

• It would have reduced choice, increased costs and jeopardized eye health for 41 million contact lens consumers.
• It would have eliminated the key provision in current law that provides for passive verification of prescriptions and would have returned to a system requiring direct verification, allowing optometrists to hold patients “hostage” and effectively deny consumers their right to buy contact lenses from alternative retailers.
• It ignored the widespread noncompliance of the FCLCA by prescribers.
• It was an anti-competitive approach that was soundly rejected by Congress in the past and should be rejected again.

How Would the CLCHPA Bill Have Changed Current Law and Unwound Consumer Protections?

The CLCHPA bill would have gutted the FCLCA, which eliminated barriers to retail competition making contact lenses easier to replace and less expensive to purchase. The bill would have effectively allowed an optometrist to block any contact lens sale that did not go through his or her office.

Through this new legislation, the American Optometric Association was advocating for additional barriers to the verification process that would have increased consumer costs, lowered convenience and raised barriers to entry, while providing no demonstrated health benefits.

Specific proposed changes included:

• Permitting any prescriber to unilaterally void the FCLCA verification protocols and require affirmative verification by simply communicating “a question or concern” to the seller.
• Authorizing prescribers to unilaterally void FCLCA provisions allowing sellers to communicate via fax, phone or email and instead requiring sellers to keep track of and use only the method of communication mandated by each of the 40,000 prescribers in the U.S.
• Allowing prescribers to indefinitely stall the verification period by mandating the seller use a method of communication that does not confirm for the seller that the prescription information has been received by the prescriber.
• Unnecessarily delaying the delivery of consumers’ lenses by limiting the hours during which a seller can communicate with the prescriber.