:::m~ AMERICAN OPTOMETRIC ASSOCIATION

:::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

----·-·- -

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

1

•

•

I

I

Dec. 7 1 2016

~

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

3

:::::~ 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

5

·:::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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HJve us contact your doctor

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How would you like to provide your prescription?

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Send us a copy of your prescnption latN

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Looking at your contacts box?

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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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- -

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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

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9 Comm'='nts

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(!;) Share

September 18, 2019 j American Optometric Association

FitiiiiiiM

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NOW

Time needed to r our

online vision exam

15

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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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Tweet

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(<?)1800 CONTAC TS

Tweet

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1-800 Contacts •

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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

·-

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

14