# :::m~ AMERICAN OPTOMETRIC ASSOCIATION

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/agency%3Aftc%3A51d315d416f89abb

## Record

- **Collection:** Agency decision
- **Document type:** Agency decision

## Text

:::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

Contact Lens Rule - Proposed
Rulemaking
Comments from the American Optometric Association
Prepared for the Federal Trade Commission
September 18, 2019

September 18, 2019 I American Optometric Association

::::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

Rulemaking History
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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

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FTC holds public workshop, The

Contact Lens Rule and The
Evolving Contact Lens Market

1

•

•

I
I

Dec. 7 1 2016

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I

Mar. 71 2018

Apr. 7, 2016

FTC Initiated the Contact
Lens Rule Ten Year
Review and requested
feedback on how the
Rule is working

May 28, 2019

f------•1----~

Sept. 3, 2015

FTC issues Proposed Rule
proposing new prescriber
requirements, no new retailer
requirements

September 18, 2019 IAmerican Optometric Association

FTC issues Supplemental
Notice of Proposed
Rulemaking, refining prescriber
requirements and introducing
new retailer requirements

2

:::::::~ AMERICAN OPTOMETRIC ASSOCIATION

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 on line vision test for contact
lens renewal

•

Opternative/Visibly partnered with 1-800-CONTACTS to offer an on line vision test in
2016

•

Hubble Contacts entered the market with 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 companls own on line 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

September 18, 2019 I American Optometric Association

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:::::~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

Reevaluating the basis for th is proposed ru le: contact lens
prices are competitive
•

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 on line 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

September 18, 2019 IAmerican 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 dat a when making
decisions about consumer choice
and the competitiveness of the
contact lens market

4

·::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

Reevaluating the basis for this proposed rule: the contact
lens market is not unique
"Several commenters said the amendment is necessary because the market for contact lenses
remains unique in that-unlike most other medical doctors-eye doctors sell the items they prescribe,
and thus are rewarded financially for driving patients to their own retail channels. a (FTC SPRM 2019)

• Attempts to paint contact lens market
and the role of doctors in that market as
unique is inaccurate
• FTC lawyers refuted this argument in

"[... ]it is common knowledge that
healthcare professionals at ambulatory
surgery centers, orthopedic centers, dental
service providers, and many other
'healthcare providers' may sell the
products that they prescribe."

2017

(FTC Complaint Counsel Finding of Fact In
the Matter of 1-800 CONTACTS, INC., a
corporation, Docket No. 9372)

September 18, 2019 IAmerican Optometric Association

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·:::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulema king
1

Reevaluating t he basis for this proposed rule: FTC s data
shows low rate of prescri ption 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 rough ly 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."
1

1

September 18, 2019 IAmerican 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

6

::::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

The reality of the Contact Lens Rule: on line retailer
practices and growth
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2 Oo,tor Info

Prescription Verification
Federal law requtres chac we verify your prescnpc1on wllh your doctor. Please note that we will not be able to shi p your order until 1r 1s
verified

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September 1 8 , 2019 I American Optometric Association

Online retailers encourage the use of passive
verification
The FTC's 2005 report included data indicating
independent doctors represented 68.6 % of the
contact lens market share
Vision Council 201 7 data shows that independent
physician share was 39%
The fastest-growing distribution channel for CL
sales in t he US was the online/lnternet channe l

7

·::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

Reevaluating the basis for this proposed rule: data used
regarding prescription release compliance is questionable
•

FTC relies heavily on misleading data provided by 1800-CONTACTS regarding prescriber compliance with
the release of contact lens prescriptions

Solution: better data is needed to

fully assess compliance
•

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

September 18, 2019 I American Optometric Association

Solution: create a dedicated

complaint system for FCLCA-related
concerns

8

,::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Ru le - Proposed Ru lemaking

1-800-CONTACTS advertisements direct patients away
from comprehensive eye examinations
The company is creating a business model built on pushing people away from their doctors and
instead use 1-800-CONTACTS' online vision exam and purchase its own brand of contact lenses
- - ---- -•• like

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Skip the trip to the optometrist and use our Express Exam to renew your
contact lens prescription https 11wv,,n,v 1800contacts comionlIne- contactlens-prescription

.

1 -800 CONTACTS

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Then vs Now Less time at the eye doctors office=more time in bed -SI
Winning• What will you do wth your extra t ime? Follow tne link to o ur on llne
vision exam mtp ,,t:; 1 1y,2v 'EJl.!ht

1-800 CONTACTS 0
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minutes

Home
About

Posts

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90

Photos

Videos

75

Job Openings

Events
Notes

60
45

Community

Q
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9 Comm'='nts

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(!;) Share

September 18, 2019 j American Optometric Association

FitiiiiiiM

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Time needed to r our
online vision exam

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·::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

1-800-CONTACTS advertisements direct patients away
from comprehensive eye examinations
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(<?)1800 CONTAC TS

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Have you tried renewing your

Save yourself an unnecessary trip to

#contactlens prescription online with

the optometrist by renewing your

our renewal test? It's easy, quick and

prescription online at home! Check

saves you the hassle of traveling to

out our Express Exam:

your eye doctor. bit.ly/2fZG2aF

1800contacts.com/ online- con tact ...

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ONLINE PRESCRIPTION
RENEWAL

ONLINE PRESCRIPTION
RENEWAL
1800 contacts

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4/2 6/18, 2:53 PM _ _____ _ _ _ _ _ _ _ _ ___

September 18, 2019 I Ame rican Optometric Association

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1800 contacts

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·:::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

Holding onl ine retailers accountable: documented
violations resulting in patient harm (1/2)
While new proposals recommended for retailers are a positive step, we believe FTC should take
immediate and direct steps to investigate and address the blatant FCLCA violations of online sellers

•

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

September 181 2019 IAmerican Optometric Association

Total Complaints

Unknown

3%

Hubble
41%

Face book

8%

11

·:::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rulemaking

Hold ing online retailers accountable: documented
violations resulting in patient harm (2/2)
While new proposals recommended for retailers are a positive step, we believe FTC should take
immediate and direct steps to investigate and address the blatant FCLCA violations of on line sellers

AOA has received complaints from doctors of
optometry who have seen patients with illegally
obtained contact lenses that 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

Septe rnber 18, 2019 i American Optometric Association

"Other" Reta ilers: Number of Complaints
Lens.com
Waldo Daily
Contact Lenses

22

Wish

• Simple Contacts
• EZContacts
• Aveo

13

12

·:::m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Ru lemaking

Holding online retailers accountable: passive verification
exploitation and robocalls
While new proposals recommended for retailers are a positive step, we believe FTC should take
immediate and direct steps to investigate and address the blatant FCLCA violations of on line sellers

•

Issues with verification requests, such as an
incomprehensible robocall, accounted for
21% of the 1,028 violation complaints sent to
AOA

Reason for Complaint
• No Rx

Wrong Rx

•

•

•

85% of doctors report that the use of
robocalls for prescription verifications has
increased over the pasts 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

September 18, 2019 j American Optometric Association

• Incomplete
verification request

• Expired Rx

Robocalls that are relied on to exploit
passive verification result in patients
receiving contact lenses that were not
prescribed, jeopardizing eye health
13

::: :m~ AMERICAN OPTOMETRIC ASSOCIATION

Contact Lens Rule - Proposed Rule makin<J

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
on line 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

September 18, 2019 I American Optometric Association

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/agency%3Aftc%3A51d315d416f89abb. Public record. Not legal advice.
