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FDA'S CONTACT LENS PROPOSAL DRAWS FIRE
Optometry to HHS: No Deregulation
No doubt you've all heard about the recent ado concerning the black market sale of nonprescription cosmetic contact lenses and the Food and Drug Administration's (FDA's) proposal to deregulate said lenses. So you're fully informed on the subject, here's a recap of what has happened.
First, we heard from the LA Times that Daniel E. Troy, the FDA's general counsel, sent a letter to the director of the Agency's Center for Devices and Radiological Health signaling interest in deregulating cosmetic lenses. And that's what started the uproar on this subject. These events followed:
- Aug. 26 -- Rep. Henry A. Waxman (D-Calif.) sent a letter to Health and Human Services Secretary Tommy G. Thompson to saying that the deregulation of cosmetic lenses "would also establish a precedent that could lead to the deregulation of many more potentially hazardous prescription drugs and devices."
- Aug. 27 -- The American Optometric Association
(AOA) agrees with Rep. Waxman and sends a statement to Secretary Thompson echoing the Association's sentiments.
- Aug. 28 -- CIBA Vision sends out a press release stating that it, "strongly supports the continued regulation by the FDA of all contact lenses, including those lenses used for cosmetic purposes that do not provide vision correction."
- Week of Sept. 2 -- CIBA Vision files a lawsuit in the U.S. District Court for the Northern District of Georgia in Atlanta against two Georgia companies for engaging in the sale and distribution of color contact lenses without prescriptions, without providing instructions for use and without medical advisories required by law. Both companies are also allegedly breaking down boxes of multiple lenses and individually selling lenses marked "not to be sold individually."
- Sept. 4 -- Sen. Edward M. Kennedy (D-Mass.) joins forces with Rep. Waxman and the AOA to convince the FDA to reconsider deregulating cosmetic lenses. In his letter, Sen. Kennedy states, "FDA's plan to deregulate colored contact lenses is bad policy and bad law."
- Sept. 9 -- Ohio State Attorney General Betty Montgomery seeks injunctions to stop the sale of contact lenses without prescriptions at four retailers in Ohio.
- Sept. 12 -- CIBA sends out another press release in which CIBA President Steve Osbaldeston states,
"CIBA Vision wants to ensure the U.S. eyecare community that we are committed to the professional dispensing and use of contact lenses in addition to the current requirement that all contact lenses be prescribed by individuals who are licensed and trained to prescribe them, fit them and provide follow-up care."
- Sept. 18 -- Robert D. Newcomb, O.D., M.P.H.,
F.A.A.O., president of the American Academy of Optometry, appeals to members to send letters to Secretary Thompson personally. He even shares with members his own letter which, among other things states, "I am writing to vigorously oppose the proposed actions by the [FDA] to re-classify (de-regulate) certain contact lenses from a medical device, which they are, to a cosmetic accessory, which they are not."
At press time (Sept. 30), nothing had stirred the waters since Sept. 18. What will the FDA's ultimate ruling be? We'll let you know as soon as we find out. In the meantime, make your voice heard -- let the government know that you disagree with its deregulation plans.
INDUSTRY MOURNS LOSS
Dr. George Mertz
George W. Mertz,
O.D., F.A.A.O., passed away on Sept. 14 after suffering from two heart attacks the day before. He had been involved in clinical research and professional education in the contact lens industry throughout his career.
Dr. Mertz worked for Vistakon since 1990, first as manager of clinical research/product analysis in R&D, then as director of academic affairs in the professional affairs division.
Dr. Mertz was also president of the American Optometric Foundation and a Diplomate in the Cornea and Contact Lens Section of the American Academy of Optometry. He published over 25 articles in refereed journals and lectured worldwide on contact lens topics. He is survived by his wife Jill.
CHAIN NOW CHARGES FEE
1-Hour Service Fee
You charge for special or extra
services. Now, so do Wal-Mart Vision Centers. National Vision's President/ COO, Reade
Fahs, recently implemented a $10 additional charge for 1-hour eyeglass service in the chain's 400 Wal-Mart stores. The company also switched from package pricing to separate prices for frames and lenses in all of its Wal-Mart optical
In the August issue of OM, Drs. John M. Rinehart and James W. Reese note the May-Grant technique that started orthokeratology about 40 years ago (see
www.optometric.com/archive_results.asp?article=70508&iss=8/1/02). Specifically, this technique applied the best possible fitting lens on the eye, which frequently may have been 1.00D flatter than flat K. As the eye flattened, the patient would be refit again to achieve the best possible lens fit. Taking months, this process continued until the eye no longer changed or the desired results were achieved.
EYE COLOR SURVEY
Now It's Easy Being Green --
Green-eyed, that is. CIBA Vision recently conducted a survey, in which it polled 1,016 women ages 16 to 35 from the United States. Of the respondents, 60% said they'd be interested in changing their eye color.
Twenty-seven percent of respondents would choose to change their eye color to green and 26% expressed an interest in the newest FreshLook ColorBlends color, amethyst. Eighteen percent of women surveyed said they'd change their eye color to blue and 13 % chose turquoise. But what about brown? Well, only 4 % picked brown, following gray (7%) and honey (5%).
PEOPLE AND PROMOTIONS
ICO names president. The Illinois College of Optometry's Board of Trustees has named Dr. Arol Augsburger president, succeeding Dr. Charles F. Mullen, who served as president for 6 years.
Luxottica announces promotion. Luxottica Group's CEO of its retail division, Cliff
Bartow, has retired but will remain actively involved in the company as a consultant to Luxottica Retail. In light of Barlow's retirement, Luxottica has promoted Kerry Bradley to COO of the retail division.
LensCleaner.com acquired. For an undisclosed amount of money, OptiSource International has acquired
LensCleaner.com, an eyeglass cleaner and cleaning cloth manufacturer, from its parent,
Disop. OptiSource will relocate LensCleaner.com's distribution operations to its own headquarters in Port Jefferson Station, N.Y.
FDA Approves Alcon's New Comfort Claims
The FDA approved new comfort claims for Alcon's
Opti-Free Express contact lens solution. The new claims printed on the retail box include:
Opti-Free Express MPDS No Rub Lasting Comfort Formula; Comfort That Lasts All Day; Lasting Moisture, Lasting Comfort; Provides Lasting Comfort for All Day Wear, Even for Sensitive Eyes; For Any Contact Lenses Including Silicone
These claims are all supported by substantial clinical data. In addition, the package inserts for the U.S. starter kits are now written in both English and Spanish.
Optometric Management, Issue: October 2002