Just in time for Halloween, Congress passes plano contact lens bill
Case/MetroHealth faculty member advocacy helped in passage of bill that will protect decorative contact lens wearers
October 31, 2005 | For more information: George Stamatis 216-368-3635
A new bill passed earlier this week by Congress regulating cosmetic plano contact lenses is being celebrated as an important victory for patient safety. The bill, S.172, sponsored by Sens. Mike DeWine, R-Ohio, and Edward Kennedy, D-Mass., amends the Federal Food, Drug and Cosmetic Act to provide that all contact lenses are considered medical devices, regardless of their use, including those mainly used in costumes or for decorative or cosmetic reasons.
Urged by reports of teenagers who developed serious eye problems after using nonprescription cosmetic lenses from unauthorized vendors, the American Academy of Ophthalmology initiated efforts three years ago to regulate cosmetic plano contact lenses with the help of academy members Gail M. Royal, M.D., of Myrtle Beach, S.C., and Thomas L. Steinemann, M.D., an associate professor of ophthalmology at the Case Western Reserve University School of Medicine and MetroHealth Medical Center.
Royal first reported 12 teens were seen through a Myrtle Beach emergency room over spring break 2002 with severe eye problems, bringing attention to this important, but often overlooked, safety issue. Steinemann also had treated similar cases in Cleveland, including one youth who suffered a blinding corneal infection following her use of decorative lenses. He was appalled at the number of new cases of similar injuries and testified before Congress and the FDA later that same year on this emerging problem.
"No matter what their purpose, all contact lenses need the same regulations to help provide the same protection for all wearers," said Steinemann. He was the principal investigator of a study released in September that provided further evidence of the dangers caused by improperly dispensed decorative plano contact lenses.
Steinemann, a constituent of Sen. DeWine, presented in his study 12 new case studies involving severe eye injuries caused by misuse of plano decorative contact lenses. All the patients obtained the lenses from vendors without a prescription, proper fitting or proper instructions on the care and use of the lenses. The study included findings from a survey of 159 patients, 23 percent of whom used decorative contact lenses. Of the plano lens wearers, 51 percent responded that they obtained the lenses from vendors without a prescription.
"It doesn't matter why you wear contact lenses—to correct your vision or just for fun—the risks posed are the same when there is no professional involvement. That's why all lenses must be properly dispensed and fit," added Royal. The new law will mandate that all contact lenses sold in the United States must be fit and dispensed by an eye care professional.
With support from eye care professional groups and American contact lens manufactures, the issue was quickly brought to the attention of legislators and nearly passed last year in the 108th Congress. This year a companion bill (H.R.371) was co-sponsored by John Boozman, R-Ark., and Henry Waxman, D-Calif., in the House but was dropped in favor of passing the Senate bill.
"We're very pleased that this initiative enjoyed support from both the Senate and the House and both sides of the aisle," said Catherine G. Cohen, Academy vice president for governmental affairs. "It was especially gratifying to see that industry and all eye heath care providers come together and support his very important issue. We want to particularly thank Sen. DeWine and Senate Health, Education, Labor and Pensions Committee Chairman Michael Enzi for their leadership on this issue. We are excited that it will soon be on the president's desk for his signature."
For more School of Medicine news, see http://casemed.case.edu/public_affairs/news/archives.cfm.
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