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United States of America
FEDERAL TRADE COMMISSION
Washington, D.C. 20580
Office of Commissioner
Rohit Chopra
To:
April Tabor
From: Samuel Levine
Date: November 20, 2019
Re:
Contact Lens SNPRM: Comments to be placed on the public record
On November 4, 2019, Commissioner Rohit Chopra met with representatives of various
organizations, at the request of the American Optometric Association (“AOA”). 1 The purpose of
the meeting was to discuss their perspective on the Commission’s Supplemental Notice of
Proposed Rulemaking (“SNPRM”) regarding the Contact Lens Rule (“Rule”).
During the meeting, the representatives raised concerns about the prescription release noncompliance surveys submitted to the public record, contending that they were unreliable because
patients frequently request prescriptions before the completion of their fitting.
Commissioner Chopra asked the representatives about the origin of the non-compliance surveys
on record, and whether they were funded directly or indirectly by sellers or other interested
parties. The representatives stated that one of the surveys on the public record was funded by 1800 Contacts. Another survey was conducted by Consumer Action, and the representatives noted
that 1-800 Contacts was a donor to that organization. Commissioner Chopra then asked if AOA
was aware of other probative data, and AOA stated that they have conducted surveys showing
high compliance, but are not aware of any other data.
AOA also expressed concern that the Commission fails to appreciate the burden imposed by the
signed acknowledgement requirement. Commissioner Chopra agreed that the Commission at
times treats small businesses unfairly, while treating larger enterprises more generously, and
sought to better understand the burden the Rule was imposing on AOA members. AOA
responded that for smaller practices, the burden is considerable, especially with the advent of
electronic medical records. Small optometry practices are also burdened through passive
verification exploitation and robocalls, AOA added.
1
In attendance from AOA were Kara Webb (Director of Coding and Regulatory Policy), David Cockrell (Advocacy
Chair), and Emily Dalgo (Regulatory Specialist). Also in attendance were Jillian Winans (Regulatory Affairs
Specialist) from The American Society of Cataract and Refractive Surgery, Scott Haber (Manager, Federal Affairs
& Public Health), and Rebecca Hyder (Director of Congressional Affairs) from the American Academy of
Ophthalmology. Samuel Levine, Commissioner Chopra’s Consumer Protection Counsel, also participated in the
meeting, as did Paige Carter, the Commissioner’s paralegal.
Commissioner Chopra agreed that it was important for the Commission to carefully consider the
burden the Rule imposes on small businesses, but added that it was also important to understand
whether firms may be incentivized to flout the Rule and impede consumer choice. Commissioner
Chopra asked for information related to a typical office’s revenue structure and personnel. AOA
shared that for most offices, eyeglasses generate more revenue than contacts, and that a typical
office with one optometrist has 3.4 employees and $800,000 in revenue.
AOA further noted that the Commission has not received many consumer complaints related to
prescription release issues, which they contended demonstrates compliance. Commissioner
Chopra responded that a lack of complaints is not a persuasive argument, and urged AOA instead
to submit data demonstrating compliance or burden. Commissioner Chopra also asked the
representatives to propose alternative frameworks that the Commission should consider, such as
limiting the signed acknowledgement requirements to patients who purchase contacts in the
office. He stressed that he was open to modifications if they were supported with rigorous data.
Commissioner Chopra asked AOA to further explain their proposal for a posted sign alternative
to the signed acknowledgement requirement. The AOA shared that, notwithstanding skeptics’
claim that doctors would not make the signs visible, they believe signs would aid in addressing
the Commission’s immediate concerns, while reducing the compliance burden for small offices.
Commissioner Chopra also discussed with AOA the contact lens market generally. AOA noted
that prices were converging among online and in-office sellers, and that consumers had more
choices than ever in purchasing lenses, which, in their view, indicated compliance. The largest
area of noncompliance, AOA contended, is among retailers who are exposing patients to harm by
selling non-prescribed or counterfeit lenses. This is a growing problem on online platforms,
AOA added, including on platforms that purport to prohibit the sale of medical devices.
Commissioner Chopra expressed his appreciation to the representatives for their input and noted
that he would be monitoring the proceeding carefully.
2
Contact Lens Rule – Proposed Rulemaking
Contact Lens Rule – Proposed
Rulemaking
Comments from the American Optometric Association
Prepared for the Federal Trade Commission
November 4, 2019
November 4, 2019 | American Optometric Association
Contact Lens Rule – Proposed Rulemaking
Rulemaking History
FTC Issues 45 letters to contact lens
prescribers and 10 to contact lens sellers
warning them of potential violations of
the agency’s Contact Lens Rule
FTC holds public workshop, The
Contact Lens Rule and The
Evolving Contact Lens Market
Dec. 7, 2016
Sept. 3, 2015
Apr. 7, 2016
FTC Initiated the Contact
Lens Rule Ten Year
Review and requested
feedback on how the
Rule is working
FTC issues Proposed Rule
proposing new prescriber
requirements, no new retailer
requirements
November 4, 2019 | American Optometric Association
May 28, 2019
Mar. 7, 2018
FTC issues Supplemental
Notice of Proposed
Rulemaking, refining prescriber
requirements and introducing
new retailer requirements
2
Contact Lens Rule – Proposed Rulemaking
Contact Lens Market Evolution
Much has changed in the contact lens market since 2015, when the 10-year review on the CLR
was initiated:
• Opternative/Visibly entered the market in 2015 providing an online vision test
• Simple Contacts entered the market in 2015 providing an online vision test for contact
lens renewal
• Opternative/Visibly partnered with 1-800-CONTACTS to offer an online vision test in
2016
• Hubble Contacts entered the market their own brand of daily contact lenses in 2016
• Waldo Contacts entered the market with their own brand of daily contact lenses in
2017
• Aveo Contacts entered the market with their own brand of daily contact lenses in 2018
• 1-800-CONTACTS disengaged with Opternative/Visibly in 2017/18 and ExpressExam
(the company’s own online vision test) was launched
• 1-800-CONTACTS launched its own brand of daily contact lenses (AquaSoft) in 2018
• In 2019, Opternative/Visibly recalled their online vision test after FDA engagement.
The reason for the recall was prompted because the company “has not received
authorization from FDA to market the product.”
• Simple Contacts, ExpressExam, Hubble Contacts, AquaSoft, Waldo, Aveo are all
currently on the market
November 4, 2019 | American Optometric Association
3
Contact Lens Rule – Proposed Rulemaking
Market Changes Since FCLCA: Sellers use leading online
platforms to sell contact lenses with a prescription
Despite AOA outreach to notify online
platforms of problematic retailers, these
leading online platforms continue to
allow contact lens sales without
requiring a prescription.
November 4, 2019 | American Optometric Association
4
Contact Lens Rule – Proposed Rulemaking
Market Changes Since FCLCA: Contact lens regulatory
requirements and health risks are misstated
The public is receiving
inaccurate and misleading
information from sellers using
these online platforms and
other websites.
November 4, 2019 | American Optometric Association
5
Contact Lens Rule – Proposed Rulemaking
Market Changes Since FCLCA: leading online platforms
lack accountability
Wish CEO Peter Szulczewski was “unfazed
by the quality-control challenge, pointing
out that sometimes customers themselves
are the problem.” He commented, “We sell
5 million contact lenses a year…someone’s
going to sleep in them.”
November 4, 2019 | American Optometric Association
6
Contact Lens Rule – Proposed Rulemaking
Market Changes Since FCLCA: Contact lens prices
converge
• To follow up the FTC’s 2005 study of
contact lens pricing, AOA conducted a
price comparison analysis that shows
the FCLCA is working and competitive
pressures on eye-care industry have
been triggered
• AOA study compared online and inoffice costs of 81 contact lenses and
found an average price difference of
$0.32 across all lenses
• 28 lenses were more expensive online,
while 53 were more expensive in the
doctor’s office.
November 4, 2019 | American Optometric Association
• FTC’s 2005 study had found:
“Not accounting for intrachannel
differences, contact lenses sold
online are on average $15 less
expensive than those sold offline”
The FTC should consider the
current contact lens market and
updated pricing data when making
decisions about consumer choice
and the competitiveness of the
contact lens market
7
Contact Lens Rule – Proposed Rulemaking
Current state of the contact lens market: retailer
violations
•
AOA received 1,028 unique complaints of
contact lens sale violations from doctors of
optometry and their staff from 2017-July 2019
•
41% of total complaints related to Hubble
•
Chief complaints were the sale of contact
lenses without a prescription; that were not
prescribed to the patient/wrong prescription;
incomplete verification requests; an expired
prescription
•
FTC could use existing authority to take
action against retailers leveraging loopholes
in the verification process and launch an
investigation into Hubble contacts
November 4, 2019 | American Optometric Association
Total Complaints
Other
31%
8%
Unknown
3%
Hubble
41%
1-800 Contacts
17%
8
Contact Lens Rule – Proposed Rulemaking
Current state of the contact lens market: contact lens
adverse events resulting in patient harm
Doctors who have seen patients with
illegally obtained contact lenses
resulted in the following adverse health
outcomes:
•
•
•
•
•
•
•
•
•
•
Keratitis
Scarring
Decrease in best corrected vision
Corneal ulcer
Infection
Corneal neovascularization
Redness and irritation
Infectious bacterial ulcer
Corneal abrasion
Inflammation
November 4, 2019 | American Optometric Association
"Other" Retailers: Number of Complaints
Lens.com
6
Waldo Daily
Contact Lenses
Wish
6
22
6
Simple Contacts
EZContacts
Aveo
6
13
9
Contact Lens Rule – Proposed Rulemaking
Current state of the contact lens market: passive
verification exploitation and robocalls
•
•
Issues with verification requests, such as an
incomprehensible robocall, accounted for
21% of the 1,028 violation complaints sent to
AOA
85% of doctors report that the use of
robocalls for prescription verifications has
increased over the past 5 years, according to
AOA survey of over 600 doctors of optometry
•
88.2% of doctors indicated that the quality of
robocalls has decreased in the past 5 years
•
Hubble relies fully on automated phone calls
to sell its own brand of contact lenses
November 4, 2019 | American Optometric Association
Reason for Complaint
No Rx
Wrong Rx
15%
35%
21%
Incomplete
verification request
29%
Expired Rx
Robocalls that are relied on to exploit
passive verification result in patients
receiving contact lenses that were not
prescribed, jeopardizing eye health
10
Contact Lens Rule – Proposed Rulemaking
Proposed Changes: Burden and Impact on Small
Businesses
• AOA annual survey of doctors of optometry found respondents reported
collecting $829,106, on average, in gross receipts in 2016.
• The Small Business Administration receipts based size standard for
doctors of optometry offices is $8 million.
• FTC estimated that, combining the aggregate labor costs for both
prescribers and office staff to obtain patient signed acknowledgments
and preserve the associated records, the Commission estimates the total
labor burden of the confirmation of prescription release proposal to be
$13,244,727.
• For the March 2016 FTC proposal to required the signed acknowledgment
form , the estimated total additional labor cost attributable to the
proposed modifications to the Rule were estimated at approximately
$10,475,495. Despite increased “flexibility” in supplemental rulemaking,
the burden estimate increased.
• Current regulatory burden for retailers who currently disregard the rule
and law is $0.
November 4, 2019 | American Optometric Association
11
Contact Lens Rule – Proposed Rulemaking
Reevaluating the need for prescriber regulatory changes:
FTC’s data shows low rate of prescription release
noncompliance
•
•
2017 Freedom of Information Act request
showed that over the 2011–2016 period, the
FTC received complaints from a total of 309
consumers out of roughly 200 million
contact lens prescriptions issued
During the March 2018 workshop, FTC staff
noted “from the FTC’s perspective, we feel
that the complaints we do get are a tip of
the iceberg. And if you don't know that you
have a right to your prescription, you
certainly don't know that you're supposed to
complain to the FTC.”
November 4, 2019 | American Optometric Association
The complaints of prescription release
noncompliance represent
approximately 0.00015% of the
contact lens prescriptions issued
between 2011-16
Solution: to address the
Commission’s immediate concern
regarding consumers’ awareness of
their rights, require doctors to post a
sign in their offices notifying patients
of their right to their prescription
12
Contact Lens Rule – Proposed Rulemaking
Reevaluating the need for prescriber regulatory changes:
data used regarding prescription release compliance is
questionable
•
FTC relies heavily on misleading data provided by
1-800-CONTACTS regarding prescriber compliance
with the release of contact lens prescriptions
•
In their July 2019 survey, 1-800-CONTACTS again
asked patients if they had to ask for their contact lens
prescription
•
1-800 CONTACTS reports 56.9% of patients who were
not “automatically provided Rx” had to ask for it
•
The data from these past two surveys equate a patient
asking for their prescription with non-compliance
•
Patient requests for prescription before a fitting is
complete are common: 91.7% of ODs say patients ask
for prescription prior to finalization of contact lens
fitting according to June 2019 AOA study
November 4, 2019 | American Optometric Association
Solution: better data is needed to
fully assess compliance
Solution: create a dedicated
complaint system for FCLCA-related
concerns
13
Contact Lens Rule – Proposed Rulemaking
Considerations
Regulatory Timing
• Congress is currently considering legislation related to the contact lens
market (The Contact Lens Prescription Verification Modernization Act)
• The FDA is following new market entrants related to contact lenses and
online applications and evaluating them for effectiveness and safety
• Given the various changes in the contact lens market with new market
entrants, new technologies, is now the appropriate time for the FTC to
implement regulatory changes?
Use Existing Authority
• Investigate patient complaints received
• Address non-compliance with retailers
Consider a Less Burdensome Alternative
• If FTC is concerned about public awareness of rights, the AOA supports a
new requirement to have prescribers post signs notifying patients of their
right to their contact lens prescription. This alternative is supported by
more than 100 U.S. Senators and House members who are on record
supporting the posted sign alternative to the FTC’s proposal.
November 4, 2019 | American Optometric Association
14
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.