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Pending legislation will amend the contact lens fairness act
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Legislation introduced in Congress would amend the Fairness to Contact Lens Consumers Act (FCLCA), requiring that vendors establish a toll-free hotline and e-mail through which to field questions from practitioners and requiring a consumer safety study by the Federal Trade Commission (FTC).
H.R. 6117, introduced by Rep. Ed Whitfield (R-Ky.) on Sept. 17, also would enable prescribers to specify their preferences for fax, e-mail or telephone for the purposes of prescription verification. The legislation is known as the Contact Lens Consumer Health Protection Act.
“The American Optometric Association (AOA) strongly supports the Contact Lens Consumer Health Protection Act,” said C. Thomas Crooks III, OD, president of the AOA, in a prepared statement. “Rep. Whitfield understands the importance of quality eye care, and we applaud his leadership on this important issue.”
Hearing before subcommittee
The introduction of H.R. 6117 resulted from a hearing held Sept. 15 before the Subcommittee on Commerce, Trade and Consumer Protection of the House Energy and Commerce Committee. The purpose of the hearing was to discuss contact lens distribution issues.
During the hearing, testimony was heard from Jonathan Coon, chief executive officer of 1-800-CONTACTS.
According to a transcript of his testimony, Mr. Coon asserted that it is the right of every contact lens wearer with a valid prescription to choose where he or she wishes to have that prescription filled. He went on to state, “Every contact lens wearer should feel confident that his or her prescription is based on health needs and not influenced by the prescriber’s financial interests.”
Mr. Coon decried “doctors only” lenses, which he claimed restricts competition.
“‘Doctors only’ lenses are marketed to eye doctors on their ability to increase prescriber profits by limiting competition and compelling patients to return to prescribers for lens purchases,” he said. “A brochure for Extreme H20 lenses [Hydrogel Vision Corp.] promises doctors ‘a lens that cannot be shopped around’ and ‘a lens that will retain your replacement business.’”
According to the testimony of Gregory A. Fryling, chief operating officer of CooperVision, claims that the company’s Proclear line of lenses is sold only to doctors is erroneous.
“The suggestion is that consumers have nowhere to go after they get a prescription for Proclear and, consequently, the prescribing optometrist or ophthalmologist can jack up the price,” he said in his testimony. “This claim bears no resemblance to the facts. Proclear is sold to over 30 retail chains, including Wal-Mart, Sears, Costco and many others, which make up over 10,000 retail outlets.”
Mr. Fryling also addressed the sales of counterfeit Proclear lenses by 1-800-CONTACTS. “We have had an unfortunate experience of counterfeit sales of Proclear by at least one major Internet supplier, 1-800-CONTACTS,” he said. “I am not saying that 1-800-CONTACTS knew these lenses were counterfeit, but these sales endangered patients’ eye health and had the potential to harm drastically the reputation of both Proclear and CooperVision itself.”
Mr. Fryling emphasized that manufacturers should be able to sell to trustworthy contact lens distributors. “It is essential that contact lens manufacturers retain the ability to choose reputable distributors that have ethical, efficient and safe business practices,” he said. “This allows manufacturers to protect and promote quality and ensure the reputation of their products.”
Details of H.R. 6117
According to the text of H.R. 6117, sellers of contact lenses must provide a toll-free hotline and a dedicated e-mail address specifically to field questions and concerns that prescribers might have. This telephone service must maintain a sufficient number of working telephone lines to allow for easy access by doctors to the service.
“If a prescriber communicates a question or concern to a seller through the toll-free telephone service and dedicated e-mail before such 8-hour period has ended, the seller must obtain affirmative confirmation of the accuracy of the prescription from the prescriber before it is considered verified,” the bill states.
H.R. 6117 also amends Section 10 of the FCLCA by calling for a consumer safety study by the FTC. This study will look at the following issues:
- the overfilling of prescriptions, providing a quantity of lenses that surpasses the expiration date of the prescription
- the dispensing of expired or inaccurate prescriptions
- lack of accessibility to the seller by the prescriber within the allotted 8 business hours, for purposes of addressing questions of prescription expiration or accuracy
- consumer health risks resulting from incorrect prescriptions dispensed by sellers.
Reactions to the bill
H.R. 6117 received unequivocal support from eye care professionals across the board, with both optometrists and ophthalmologists applauding the legislation.
“We are supportive of what we feel is ultimately in the best interests of patient safety,” said American Academy of Ophthalmology spokesperson Thomas L. Steinemann, MD, in an interview with Primary Care Optometry News. “We know that patients are shopping for the best buys in contact lenses, but we also want to emphasize that contact lenses are medical devices and must be prescribed with all specifications accurate and up-to-date.”
Dr. Steinemann said the telephone hotline would provide valuable recourse for prescribing practitioners. “This will enable prescribers to suspend the transaction until the discrepancy is resolved,” he said. “We want to ensure that prescriptions are verified accurately. It’s obviously a safety issue.”
According to Steven L. Compton, OD, president of the Kentucky Optometric Association, the recent outbreak of Fusarium keratitis among contact lens wearers served as an alarming reminder that contact lenses are medical devices.
“This underscores the fact that contact lenses are, indeed, prescription medical devices that can cause serious injury when improperly fit, worn or maintained,” Dr. Compton told Primary Care Optometry News. “Unfortunately, optometrists here and across the country continue to see harmful and disruptive prescription verification practices used by the online contact lens sales industry.”
Dr. Compton lauded the measure as a necessary and valuable means of protection for all patients. “H.R. 6117 will provide our friends and neighbors here in Kentucky, as well as every American, with the strengthened safeguards they need and deserve,” he said.
For more information:
- C. Thomas Crooks III, OD, is president of the American Optometric Association. He can be reached at 243 N. Lindbergh Blvd., St. Louis MO 63141; (800) 365-2219; fax: (314) 991-4101.
- Jonathan Coon is chief executive officer of 1-800-CONTACTS. He can be reached at 66 East Wadsworth Park Dr., 3rd Flr., Draper, UT 84020; (415) 397-7600; (415) 397-7603.
- Gregory A. Fryling is chief operating officer of CooperVision. He can be reached at 370 Woodcliff Dr., Ste. 200, Fairport, NY 14450; (585) 264-3250.
- Thomas L. Steinemann, MD, is on staff at Metro Health Care Center in Cleveland and is associate professor of ophthalmology at Case Western Reserve University. He is a spokesperson for the American Academy of Ophthalmology. He can be reached at Division of Ophthalmology, MetroHealth Medical Center, 2500 MetroHealth Dr., Cleveland, OH 44109-1998; e-mail: tsteinemann@metrohealth.org.
- Steven L. Compton, OD, is president of the Kentucky Optometric Association. He can be reached at 403 N. College St., Franklin, KY 42134; (270) 586-5181; e-mail: FSEyecare@aol.com.