TheWeekInCongress.com
Week Ending October 28, 2005
S.172 A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of all contact lenses as medical devices, and for other purposes.
BRIEF
Contact lenses prescribed to correct vision problems are considered medical devices by the Food and Drug Administration. Decorative, non-corrective lenses are regulated as cosmetics. This bill would include non-corrective lenses as medical devices as well.
The report accompanying the bill explained that non-corrective contacts can be sold without prescription but would be worn without proper fitting. The result can be damage to the eyes ranging from temporary injury to the eye to ocular ulcers and even the loss of an eye. Designation as a medical device then comes with the requirement that non-corrective lenses be sold through prescription.
Sponsor: Senator Mike DeWine (OH)
Vote: Passed Senate by Unanimous Consent October 24, 2005
Cost to the taxpayers: CBO determines the bill would cost the FDA less than $500,000.
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MORE INFORMATION
`Plano' contact lenses are zero powered, non-corrective contact lenses that are used to change the appearance of the normal eye in a decorative fashion. Most contact lenses currently marketed in the United States, including certain plano and decorative contact lenses, have been cleared as medical devices pursuant to premarket notifications under Section 510(k) of the FFDCA by the Food and Drug Administration (FDA). The FDA has asserted medical device jurisdiction over most corrective and noncorrective contact lenses currently marketed in the United States, including certain plano and decorative contact lenses, so as to require approval pursuant to premarket approval applications under Section 515 of the FFDCA or clearance pursuant to premarket notifications for dispensing pursuant to the lawful prescriptions of eye care professionals.
However, some non-corrective, decorative contact lenses have not been approved by FDA and are sold without a prescription. The FDA regulates these non-corrective contact lenses under its cosmetic authority in Chapter VI of the FFDCA. These contact lenses present a public health threat.
One such example involved a teenage girl from Cleveland who bought colored contact lenses from a video rental store for the purpose of matching her eyes with her dress. The lenses were sold without fitting or instruction. Shortly after wearing the colored contact lenses, she was admitted to a Cleveland hospital where her left eye become so badly infected the doctor feared that she might not only lose her sight, but she could actually lose her eye. She was in the intensive care unit for 4 days.
The problem is national in scale. Contact lens insertion without appropriate supervision and fitting has been linked to ocular ulcers, as well as temporary and permanent vision problems. In Wyoming, Dr. Roger Jordan of Gillette reported a personal experience with a teenager who came in to see him with vision problems that resulted from an unlicensed person giving her plano lens that she put over her corrective lenses.
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No reproduction or distribution without written permission from TheWeekInCongress.com.