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Washington, DC—Two years after a Cleveland ophthalmologist began lobbying Congress to regulate cosmetic contact lenses as medical devices, the bill is on its way to the president's desk for a signature.
Washington, DC-Two years after a Cleveland ophthalmologist began lobbying Congress to regulate cosmetic contact lenses as medical devices, the bill is on its way to the president's desk for a signature.
In a unanimous voice vote Oct. 26, the House passed the Senate's version of a bill that identifies the decorative lenses as medical devices that-like vision-correcting contact lenses-must be prescribed, fitted, and dispensed by an eye-care professional.
The vote was celebrated by Thomas L. "Tim" Steinemann, MD, and others who had first reported in October 2003 on the dangers of the cosmetic lenses, which are frequently sold at such places as gas stations and video stores.
The House vote confirms that the legislative process works, Dr. Steinemann said.
"It is really exciting," he said. "It's my hope that this will ensure safety for all contact lens wearers. It doesn't matter why you're wearing the lens, to correct vision or just for fun, the potential to cause harm is the same, the physical risks to the cornea are the same. It makes no sense to have a different regulatory policy for decorative or fun contact lenses versus corrective ones."
The FDA said it had no authority to regulate the cosmetic lenses as medical devices because manufacturers did not claim to alter vision, only the appearance of the eyes.
Dr. Steinemann became an advocate for changing the law, appearing on national television and lobbying legislators in Washington. He joined the board of the Contact Lens Association of Ophthalmologists (CLAO) and the Research, Regulatory, and External Scientific Affairs Committee of the American Academy of Ophthalmology in an effort to gain support for his position. He spoke to representatives of 30 to 40 legislators at an Oct. 7 congressional briefing in Washington.
His pleas were heard by several legislators, including Sens. Mike DeWine (R-OH) and Edward Kennedy (D-MA), who sponsored a bill that passed the Senate in July. Reps. John Boozman (R-AK) and Henry Waxman (D-CA) sponsored a bill in the House, but the bills were so similar, the House voted on the Senate's version instead, saving a trip to a conference committee to merge the two, Dr. Steinemann said.
Sen. DeWine said the FDA has no authority to review cosmetics for safety or effectiveness before they are sold to the public, so non-corrective lens manufacturers were not required to include directions for use or test lenses for safety problems.
"By providing the FDA with the regulatory authority over cosmetic contact lenses, we'll prevent countless and senseless eye injuries each year," Sen. DeWine said in a press release.
Meanwhile, Dr. Steinemann continued to encounter more patients who had misused the cosmetic lenses, and he published a follow-up report in October.
The report confirmed the earlier study, with four of the 12 people in the case study suffering lost vision after blinding infections that required hospital admission. One of those four needed a corneal transplant.
None of them had previously worn contact lenses, and none of the decorative lenses were dispensed by a professional. Four had borrowed lenses from friends or family, and seven had worn these lenses overnight-one for as long as 6 weeks.
A separate study Dr. Steinemann published at the same time involved 159 subjects, ages 12 to 20 during the summer of 2003. Fifty-one percent of the time, the lenses were obtained from an unlicensed vendor.
Dr. Steinemann, an associate professor of ophthalmology at Case Western Reserve University, Cleveland, said the studies show that young people who do not receive contact lenses through an eye-care professional are unaware of the significant dangers they can cause. Some of the patients were in their mid to late 30s.