[Congressional Record Volume 149, Number 145 (Thursday, October 16, 2003)]
[Senate]
[Page S12745]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DeWINE (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.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1747

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. FINDINGS.

       Congress finds as follows:
       (1) All contact lenses have significant effects on the eye 
     and pose serious potential health risks if improperly 
     manufactured or used without appropriate involvement of a 
     qualified eye care professional.
       (2) Most contact lenses currently marketed in the United 
     States, including certain plano and decorative contact 
     lenses, have been approved as medical devices pursuant to 
     premarket approval applications or cleared pursuant to 
     premarket notifications by the Food and Drug Administration 
     (``FDA'').
       (3) FDA has asserted medical device jurisdiction over most 
     corrective and noncorrective contact lenses as medical 
     devices currently marketed in the United States, including 
     certain plano and decorative contact lenses, so as to require 
     approval pursuant to premarket approval applications or 
     clearance pursuant to premarket notifications.
       (4) All contact lenses can present risks if used without 
     the supervision of a qualified eye care professional. Eye 
     injuries in children and other consumers have been reported 
     for contact lenses that are regulated by FDA as medical 
     devices primarily when used without professional involvement, 
     and noncorrective contact lenses sold without approval or 
     clearance as medical devices have caused eye injuries in 
     children.

     SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL DEVICES.

       Section 520 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360j) is amended by adding at the end the following 
     subsection:

                ``Regulation of Contact Lens as Devices

       ``(n)(1) All contact lenses shall be deemed to be devices 
     under section 201(h).
       ``(2) Paragraph 1 shall not be construed as having any 
     legal effect on any article that is not described in that 
     paragraph.''.
                                 ______