fda to regulate decorative contact lenses as a medical device under new law


Consumers' eyes will be better protected thanks to a new law signed by President Bush Wednesday. The law gives the Federal Drug Administration (FDA) the power to regulate zero power decorative contact lenses as medical devices, meaning that consumers

(I-Newswire) November 10, 2005 - FDA TO REGULATE DECORATIVE CONTACT LENSES
AS A MEDICAL DEVICE UNDER NEW LAW

Optometrist and U.S. Representative John Boozman
Advocated for Consumer Protection Legislation

Washington- November 10, 2005 - Consumers' eyes will be better protected thanks to a new law signed by President Bush Wednesday. The law gives the Federal Drug Administration (FDA) the power to regulate zero power decorative contact lenses as medical devices, meaning that consumers must now see an eye doctor for all contact lens prescriptions. Previously, decorative contact lenses were unregulated and considered a cosmetic, thus consumers could purchase lenses on the Internet, at retail and convenience stores, flea markets and even gas stations.

Rep. John Boozman (R-Ark.) led the bi-partisan effort to pass S.172 in the U.S. House on Oct. 26 and close a 2 ½-year-old loophole that, in spite of warnings by the nation's eye care providers and federal health officials, has allowed decorative contact lenses to be considered an unregulated cosmetic rather than a regulated medical device. With mounting evidence of grievous harm resulting from the unsupervised use of decorative lenses provided to Congress by the American Optometric Association (AOA) and other organizations, the U.S. Senate acted first and approved S.172 in July with strong support from Senators Michael Enzi (R-Wyo.), Mike DeWine (R-Ohio) and Edward Kennedy (D-Mass.).

"The unregulated, unsupervised use of decorative contact lenses has been shown to be extremely hazardous to one's health and I am pleased that Congress and the President have made passing and enacting this law a priority," said Rep. Boozman, chief House sponsor of the legislation and a practicing optometrist for 25 years prior to his election to Congress. "By acting in a timely manner, our government is sending a message to parents and young adults that decorative contact lenses, like contact lenses intended for correcting vision, present serious risks to eye health if they are used without the appropriate involvement of a qualified eye care professional."

"Our president has acted decisively to restore an eye health protection that consumers need and deserve," said Richard L. Wallingford, president of the AOA. "Optometry was proud to support Rep. Boozman's leadership and the work of his congressional colleagues in making passage of his contact lens safety legislation a top priority this year."

Decorative contact lenses -- often with striking colors or an unusual design -- have become increasingly popular and are worn mostly, but not exclusively, by high school and college students. The improper use of decorative contact lenses can cause permanent eye injury or potentially lead to blindness. Since 2003 the FDA has issued warnings to consumers and has acknowledged receiving reports of corneal ulcers associated with wearing decorative lenses as well as other conditions leading to infections and permanent loss of vision. Other risks associated with the use of decorative contact lenses include conjunctivitis (an infection of the eye), corneal edema (swelling), allergic reaction and corneal abrasion due to poor lens fit.
"Decorative and other non-corrective contact lenses, dispensed without a prescription or fitting from licensed professionals, have been linked to corneal ulcers and other ophthalmic problems," said Senator Enzi, Chairman of the U.S. Senate Committee on Health, Education, Labor and Pensions. "That's a health risk that needs our attention, and I'm pleased that the FDA now has the authority to protect users of these products, particularly children and adolescents, from unsafe and unregulated non-corrective lenses."

In January 2005, the AOA launched an aggressive nationwide grassroots effort to educate members of Congress and the general public about unsupervised decorative contact lens misuse and to build support for S.172. Hundreds of doctors of optometry from across the U.S. traveled to Washington, D.C., in April to hold face-to-face meetings with members of Congress and to deliver detailed fact sheets on the bill. On Oct. 7, the AOA joined with other ophthalmic organizations in a Capitol Hill briefing aimed at providing lawmakers with the most up-to-date information on the misuse of decorative contact lenses. On Oct. 26, with the help of Rep. Boozman, S.172 passed in the U.S. House.

About the American Optometric Association (AOA):
The American Optometric Association represents more than 34,000 doctors of optometry, optometry students and paraoptometric assistants and technicians. Optometrists provide more than two-thirds of all primary eye care in the United States and serve patients in nearly 6,500 communities across the country. In 3,500 of those communities they are the only eye doctors.

American Optometric Association doctors of optometry are highly qualified, trained doctors on the frontline of eye and vision care who examine, diagnose, treat and manage diseases and disorders of the eye. In addition to providing eye and vision care, optometrists play a major role in a patient's overall health and well-being by detecting systemic diseases such as diabetes and hypertension.

Prior to optometry school, optometrists undergo three to four years of undergraduate study that typically culminates in a bachelor's degree with extensive, required coursework in areas such as advanced health, science and mathematics. Optometry school consists of four years of post-graduate, doctoral study concentrating on both the eye and systemic health. In addition to their formal training, doctors of optometry must undergo annual continuing education to stay current on the latest standards of care. For more information, visit www.aoa.org.
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American Optometric Association/Jon Hymes




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November 10, 2005

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