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 Bills Introduced to Amend FDA Regulation of Non-Corrective CLs, CL Rx Release
WASHINGTON, D.C.--May 28, 2003 -Representative John Boozman, OD (R-Ark.) and seven other members of the U.S. House of Representatives have introduced HR2218, asking the U.S. Food and Drug Administration to amend its Cosmetic Act to "provide for the regulation of non-corrective contact lens as medical devices." The bill designates both corrective and non-corrective CLs as medical devices with potential health risks and assigns regulation of both to the FDA. The bill was referred to the House Committee on Energy and Commerce on May 22. Another bill, HR2221, has been introduced by Representative Richard Burr (R-N.C.) and three others, to ensure CL prescription release to patients whether the Rx was requested or not and to restrict any vendor from representing that CLs can be obtained without a prescription.
 FDA Approves CIBA Focus Night & Day CLs for Therapeutic Use
ATLANTA, GA.--May 08, 2003--The U.S. Food and Drug Administration has approved CIBA Vision's Focus Night & Day silicone-hydrogel soft contact lenses for therapeutic use, which will allow doctors to prescribe them as a bandage lens to protect the cornea and relieve corneal pain. The CLs, which were approved for up to 30 nights of  continuous wear in late 2001, will be available in the U.S. in Plano (no prescription) during the second half.
CIBA Parent Files CL Patent-Infringement Suit against B&L in Ireland
DUBLIN, Ireland--Mar. 25, 2003 - Novartis AG,  parent company of CIBA Vision, has filed a patent-infringement lawsuit in the High Court here against Bausch & Lomb on CIBA's behalf. The lawsuit charges that B&L's PureVision contact-lens technology infringes on an Irish patent that protects CIBA's Focus Night & Day CLs. Novartis is seeking to have the court prohibit B&L from manufacturing and selling PureVision CLs in Ireland.
Last year, CIBA prevailed in a US patent-infringement case against B&L, halting PureVision sales and manufacturing in the U.S. until April 2005; B&L subsequently moved its PureVision manufacturing and marketing operations to Waterford, Ireland.
B&L acknowledged the suit in a statement, characterizing it as "just another part of the long worldwide battle" between the two CL firms, and said it would vigorously defend its position.
AARP Finally Supports Mandatory Vision Testing for Florida Seniors
TALLAHASSEE, Fla.--Mar. 25,2003 - For the first time, the American Association of Retired Persons is backing a perennial bill in the Florida legislature that would require state residents aged 80 or older to take new vision tests every time they renew their driving licenses. The AARP's support comes as a surprise to lawmakers in Florida, where AARP has three million members and where similar bills, first introduced in 1986, have failed ten times--in part because of strong opposition from senior-citizen lobbying groups including the AARP.
Currently, 12 other states have special licensing provisions for older drivers. In Florida, however, the six-year driver's license can be renewed by mail, with no vision testing required, as long as the driver has not had an accident during the first six-year period--so many Florida drivers go 12 years without having their vision tested by the license bureau.
CIBA Vision Recalls Glitter Eye Contact Lenses
ATLANTA, GA.--April 1, 2003 - CIBA Vision, the eyecare unit of Novartis is voluntarily recalling its Glitter Eyes soft contact lenses, spurred by recent lens-care compatibility studies showing that layers of the lens can partially delaminate, "causing the pigments encapsulated within the lens to smear, smudge, or pool." According to a company spokesperson, CIBA has not received reports of any adverse effects, but is closely examining the Glitter Eyes development and manufacturing process to address the issue. All pigments remain encapsulated within the lens material, so CIBA "believes that any such issues will be limited to changes in the cosmetic effect of the lens, minor discomfort and inconvenience," the spokesperson said. Specific instructions regarding the return of the CLs are being provided directly to ECPs and distributors in the U.S. and Canada, the only countries with Glitter Eyes in the marketplace at the time of the recall.
Florida's Governor Signs Bill Requiring Vision Tests for Older Drivers
TALLAHASSEE, Fla.--Jun 01,-2003--Florida governor Jeb Bush has signed a bill mandating vision checks for elderly drivers who want to renew their drivers licenses. The measure, which takes effect January 1, requires Floridians 80 or older who apply to renew their licenses to be tested at driver's-license offices or--if renewing by mail--to submit a form signed by a doctor confirming that their vision is adequate. Under current Florida law, the six-year license can be renewed by mail, with no vision test required, if the driver has not had an accident during the first six years, so many drivers go 12 years without having their vision checked. Only 13 other states have special requirements for older drivers to renew their licenses.
B&L Files Patent Infringement Lawsuit Against CIBA
ROCHESTER, N.Y.--Aug. 20, 2003--Bausch & Lomb has filed a patent infringement lawsuit in the Federal District Court here against CIBA Vision, the eyecare unit of Novartis. The suit alleges infringement of a patent issued on July 22, 2003 by the U.S. Patent & Trademark office that relates to contact-lens chemical compositions. B&L says that CIBA's Focus Night & Day contact-lenses infringe on the recently-issued patent, which is a continuation of the patent at issue in a pending B&L suit against CIBA filed in November 2001. B&L is seeking injunctive relief and monetary damages in the suit. A CIBA spokesman said that CIBA lawyers are currently reviewing the B&L claims and that the company is "confident in the strength of our patent protection for Focus Night and Day."
A.A.O. Issues New Warning on Black-Market Contact Lenses
SAN FRANCISCO--The American Academy of Ophthalmology issued a new warning for parents this week about teenagers wearing cosmetic contact lenses purchased without prescriptions. The A.A.O. said it has received reports of several patients--mostly teens--who experienced eye problems after wearing costume CLs purchased without an Rx from retail establishments such as gas stations and beachwear stores not legally allowed to dispense contact lenses. "We don't know where these contact lenses have come from, what materials and dyes were used to make them, and whether or not they're even sterile," said Academy spokesperson and Contact Lens Association of Ophthalmologists president Peter R. Kastl, MD. "There is an erroneous assumption by people that just because CLs are not being used to correct a refractive error such as near- or farsightedness, you don't need to see an eyecare professional."

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