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:::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingContact Lens Rule - ProposedRulemakingComments from the American Optometric AssociationPrepared for the Federal Trade CommissionSeptember 18,September 18, 2019 I American Optometric Association2019

::::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingRulemaking History----·-·- -FTC Issues 45 letters to contact lensprescribers and 10 to contact lens sellerswarning them of potential violations ofthe agency s Contact Lens Rule---FTC holds public workshop, TheContact Lens Rule and TheEvolving Contact Lens Market1 IIDec. 7 1 2016Apr. 7, FTC Initiated the ContactLens Rule Ten YearReview and requestedfeedback on how theRule is workingMayf------ 1---- Sept. 3, 2015IMar. 712016FTC issues Proposed Ruleproposing new prescriberrequirements, no new retailerrequirementsSeptember 18, 2019 IAmerican Optometric Association28, 20192018FTC issues SupplementalNotice of ProposedRulemaking, refining prescriberrequirements and introducingnew retailer requirements2

::::::: AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingContact Lens Market EvolutionMuch has changed in the contact lens market since 2015, when the 10-year review on the CLRwas 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 contactlens renewal Opternative/Visibly partnered with 1-800-CONTACTS to offer an on line vision test in2016 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 2017Aveo Contacts entered the market with their own brand of daily contact lenses in 20181-800-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. Thereason for the recall was prompted because the company \\has not receivedauthorization from FDA to market the product." Simple Contacts, ExpressExam, Hubble Contacts, AquaSoft, Waldo, Aveo are allcurrently on the marketSeptember 18,2019IAmerican Optometric Association3

::::: AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingReevaluating the basis for th is proposed ru le: contact lensprices are competitive To follow up the FTC's 2005 study ofcontact lens pricing, AOA conducted aprice comparison analysis that showsthe FCLCA is working and competitivepressures on eye-care industry havebeen triggered AOA study compared on line and inoffice costs of 81 contact lenses andfound an average price difference of 0.32 across all lenses 28 lenses were more expensive online,while 53 were more expensive in thedoctor's officeSeptember 18,2019IAmerican Optometric Association FTC's 2005 study had found:\\Not accounting for intrachanneldifferences, contact lenses soldonline are on average 15 lessexpensive than those sold offline"The FTC should consider thecurrent contact lens market andupdated pricing dat a when makingdecisions about consumer choiceand the competitiveness of thecontact lens market4

·::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingReevaluating the basis for this proposed rule: the contactlens market is not unique"Several commenters said the amendment is necessary because the market for contact lensesremains 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 marketand the role of doctors in that market asunique is inaccurate FTC lawyers refuted this argument in"[. ]it is common knowledge thathealthcare professionals at ambulatorysurgery centers, orthopedic centers, dentalservice providers, and many other'healthcare providers' may sell theproducts that they prescribe."2017(FTC Complaint Counsel Finding of Fact Inthe Matter of 1-800 CONTACTS, INC., acorporation, Docket No. 9372)September 18,2019IAmerican Optometric Association5

·:::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed Rulema king1Reevaluating t he basis for this proposed rule: FTC s datashows low rate of prescri ption release noncompliance Freedom of Information Act requestshowed that over the 2011-2016 period, theFTC received complaints from a total of 309consumers out of rough ly 200 millioncontact lens prescriptions issued2017During the March 2018 workshop, FTC staffnoted \\from the FTC's perspective, we feelthat the complaints we do get are a tip ofthe iceberg. And if you don t know that youhave a right to your prescription, youcertainly don t know that you're supposed tocomplain to the FTC."11September 18,2019IAmerican Optometric AssociationThe complaints of prescription releasenoncompliance representapproximately 0.00015% of thecontact lens prescriptions issuedbetween 2011-16Solution: to address theCommission's immediate concernregarding consumers' awareness oftheir rights, require doctors to post asign in their offices notifying patientsof their right to their prescription6

::::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingThe reality of the Contact Lens Rule: on line retailerpractices and growth- - --··-·· My (d,t1 Sh1pp1n1t-- -··---·- ··· - - ·--- - - - - - --- - -- - -- - --2 Oo,tor InfoPrescription VerificationFederal 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 1sverified--- ----------- ------------------1800 contacts0. .HJve us contact your doctor: ,,:,.:, 1 : : .--:c, .- , ·-,: :r,, r · , , . ,.'! .\t ,.,.o-r : ;;,· ,,. o , -How would you like to provide your prescription? .Send us a copy of your prescnption latN,',r,. i,e:,,:;. ·. ,·, . : l ,t: :r , :. - :· ::,., ' :,-",; , .,' ; · , ::. . ,c- · : :r .r ' : : Y\Ai', H.1ssle FreeL:2.J ReturnsDoctor InformationHove your written prescriptiotl?Looking at your contacts box?IJplood a photo[ntar manually.,.,,.,,,,'.(]) OrQer h 1h :111, llon @D o c tor lnformatfo nc , .ult t C "' 1 Day Acuvu e .,,Po1.rten l D.:lltt- of BirthNeed He lp?Moolh O oct or o r S to re N me"Ooclor Phone'"i NZldi: September 1 8 ,2019p.,,. ·, ,.,,.,.,/J\ Cust omer S rvic e\.24 Availabm 24 17Pfe;u;e en1e, Iha doctOf and p.1t1en1 mfomlaUon ff)( Iha 00111act 181'ls es) OOlow This w1f01mallon \viii assist us ,n venty1r,g your prM cripllon ar- J \VIII l\otrlp0xpoc.hte th e procesi:-ifl(J of ynur n,c1er. \" . illl.:dll : t b l 1.l-.rndf' .Patien t Nam 'IAmerican Optometric AssociationOnline retailers encourage the use of passiveverificationThe FTC's 2005 report included data indicatingindependent doctors represented 68.6 % of thecontact lens market shareVision Council 201 7 data shows that independentphysician share was 39%The fastest-growing distribution channel for CLsales in t he US was the online/lnternet channe l7

·::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingReevaluating the basis for this proposed rule: data usedregarding prescription release compliance is questionable FTC relies heavily on misleading data provided by 1800-CONTACTS regarding prescriber compliance withthe release of contact lens prescriptionsSolution: better data is needed tofully assess compliance In their July 2019 survey, 1-800-CONTACTS againasked patients if they had to ask for their contact lensprescription 1-800 CONTACTS reports 56.9% of patients who werenot "automatically provided Rx" had to ask for it The data from these past two surveys equate a patientasking for their prescription with non-compliance Patient requests for prescription before a fitting iscomplete are common: 91.7% of ODs say patients askfor prescription prior to finalization of contact lensfitting according to June 2019 AOA studySeptember 18,2019IAmerican Optometric AssociationSolution: create a dedicatedcomplaint system for FCLCA-relatedconcerns8

,::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Ru le - Proposed Ru lemaking1-800-CONTACTS advertisements direct patients awayfrom comprehensive eye examinationsThe company is creating a business model built on pushing people away from their doctors andinstead use 1-800-CONTACTS' online vision exam and purchase its own brand of contact lenses- - --- 1 -80 0 CONTAC TSJul:, 1·1. 2018 like&,. Share---;' Suggest Edits- -- - - - . ASkip the trip to the optometrist and use our Express Exam to renew yourcontact lens prescription https 11wv,,n,v 1800contacts comionlIne- contactlens-prescription.1 -800 CONTACTS,. ,,, 1 \.4'Then vs Now Less time at the eye doctors office more time in bed -SIWinning What will you do wth your extra t ime? Follow tne link to o ur on llnevision exam mtp ,,t:; 1 1y,2v 'EJl.!ht1-800 CONTACTS 0:, Uh.cc·nar.tsminutesHomeAboutPosts10 5THENTime needed for a v1s1on exum90PhotosVideos75Job OpeningsEventsNotes6045CommunityQ-·--·-129 Comm' 'nts- - -- -- - --September 18,2019 j American-(!;) ShareOptometric AssociationFitiiiiiiM30NOWTime needed to r ouronline vision exam15II9

·::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed Rulemaking1-800-CONTACTS advertisements direct patients awayfrom comprehensive eye examinations Tweet&\ 1-800 Contacts 0-( ?)1800 CONTAC TSTweetA1-800 Contacts l 1800CONTACTSHave you tried renewing yourSave yourself an unnecessary trip to#contactlens prescription online withthe optometrist by renewing yourour renewal test? It's easy, quick andprescription online at home! Checksaves you the hassle of traveling toout our Express Exam:your eye doctor. bit.ly/2fZG2aF1800contacts.com/ online- con tact .- -ONLINE PRESCRIPTIONRENEWALONLINE PRESCRIPTIONRENEWAL1800 contacts.l b-; . - . . -- : . . - · . . : . ·.·. . : '4/2 6/18, 2:53 PMSeptember 18,2019I Ame rican Optometric Association·-IiI1800 contacts. :-·.·.::-.:.: :-.:.:::.-::.:: .: -. . :·· ·.:· :. ··: .8/14/1 8 , 1: 30 PM10

·:::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingHolding onl ine retailers accountable: documentedviolations resulting in patient harm (1/2)While new proposals recommended for retailers are a positive step, we believe FTC should takeimmediate and direct steps to investigate and address the blatant FCLCA violations of online sellers AOA received 1,028 unique complaints ofcontact lens sale violations from doctors ofoptometry and their staff from 2017-July 2019 41% of total complaints related to Hubble Chief complaints were the sale of contactlenses without a prescription; that were notprescribed to the patient/wrong prescription;incomplete verification requests; an expiredprescription FTC could use existing authority to takeaction against retailers leveraging loopholesin the verification process and launch aninvestigation into Hubble contactsSeptember 1812019IAmerican Optometric AssociationTotal ComplaintsUnknown3%Hubble41%Face book8%11

·:::m AMERICAN OPTOMETRIC ASSOCIATIONContact Lens Rule - Proposed RulemakingHold ing online retailers accountable: documentedviolations resulting in patient harm (2/2)While new proposals recommended for retailers are a positive step, we believe FTC should takeimmediate and direct steps to investigate and address the blatant FCLCA violations of on line sellersAOA has received complaints from doctors ofoptometry who have seen patients with illegallyobtained contact lenses that resulted in thefollowing adverse health outcomes: KeratitisScarringDecrease in best corrected visionCorneal ulcerInfectionCorneal neovascularizationRedness and irritationInfectious bacterial ulcerCorneal abrasionInflammationSepte rnber 18,2019i American Optometric Association"Other" Reta ilers: Number of ComplaintsLens.comWaldo DailyContact Lenses22Wish Simple Contacts EZContacts Aveo1312