Statements on Introduced Bills and Joint Resolutions - S. 1747

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Mr. D eWINE (for himself, Mr. Kennedy, and Mr. Dodd):

S. 1747. 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; to the Committee on Health, Education, Labor, and Pensions.

Mr. DeWINE. Mr. President, I rise today, with my colleague from Massachusetts, Senator Kennedy, to introduce an important piece of legislation, which will help protect the health of contact lens wearers, by ensuring that all contact lenses satisfy the same regulatory requirements for approval.

Currently, non-corrective contact lenses, such as decorative lenses that change eye color or have some design on them, are regulated under the Food and Drug Administration's cosmetic authority. The problem is this. The FDA does not review cosmetics for safety or effectiveness before they are sold to the public. This means that the FDA cannot require manufacturers to test non-corrective lenses for safety problems, cannot set "good manufacturing practices," and cannot even require that these lenses carry directions for safe use. This lack of FDA review and lack of established safety standards can lead to the marketing of lenses that are neither safe nor suitable for wearing.

An article in the most recent issue of the medical journal Eye & Contact Lens describes the cases of six people injured by the sale of unregulated colored contact lenses. As the article points out, four of the six patients reside in the greater Cleveland area. This obviously concerns me. But what concerns me more is that three of the five female patients were teenagers.

One such case 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 instructions. Prior to putting these lenses in her eyes, she had no previous problems with her vision and had never worn contact lenses.

Shortly after wearing the colored contact lenses, she was urgently admitted to a Cleveland hospital where it was determined that the vision in her left eye had become so poor that she could only make out hand motions. She stayed in the ICU for four days because that was the only place where she could receive the treatment necessary for her eye. Worse yet, her doctor feared that she would not only lose her sight, but that she might actually lose her eye.

In an effort to restore vision, her doctor recommended a corneal transplant, which she underwent. Nearly two years after the infection started, her vision has not been fully restored. For the rest of her life, this young girl will be at risk for rejection of the transplant, cataracts and glaucoma.

This type of injury can be prevented. The bill that Senator Kennedy and I are introducing today would allow non-corrective lenses to be reviewed before they are marketed and before they are accessible to young people. This bill, which has the endorsement of leading organizations in eye care—representing thousands of health care professionals and consumers and the contact lens industry—would clarify that all contact lenses are devices and are to be approved under the FDA's device authority. Applying the medical device requirements across-the-board to all contact lens manufacturers and distributors would help ensure that all companies are held to the same important safety standards.

Our bill would be a positive step forward in helping to prevent unnecessary eye injuries. I urge my colleagues to support passage of this legislation.