[Congressional Record Volume 149, Number 168 (Wednesday, November 19, 2003)]
[House]
[Pages H11565-H11567]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      REGULATION OF NONCORRECTIVE CONTACT LENS AS MEDICAL DEVICES

  Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 2218) to amend the Federal Food, Drug, and Cosmetic Act to 
provide for the regulation of noncorrective contact lens as medical 
devices, and for other purposes.
  The Clerk read as follows:

                               H.R. 2218

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

     SECTION 1. FINDINGS.

       The 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.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Florida (Mr. Bilirakis).


                             General Leave

  Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days within which to revise and extend their 
remarks and to include extraneous material on H.R. 2218, the bill now 
under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Florida?
  There was no objection.

                              {time}  1515

  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today in support of H.R. 2218, which amends the 
Federal Food, Drug and Cosmetic Act to provide for the regulation of 
noncorrective contact lens as medical devices, and I commend the 
gentleman from Arkansas (Mr. Boozman) for his work on this legislation.
  As the corrective contact lens industry has grown, so has the 
practice of using noncorrective contact lenses for cosmetic purposes. 
Currently, there is very little regulation of these lenses. However, 
all contact lenses have significant effects on the eye and pose health 
risks if improperly manufactured or used without the supervision of a 
qualified eye care practitioner. Both corrective and noncorrective 
contact lenses have been approved as medical devices by the FDA. It 
just makes sense that the FDA should have the authority to regulate 
these lenses.
  Mr. Speaker, having said that, I would urge all of my colleagues to 
support this important resolution.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, colored and patterned contact lenses can be a fun way to 
express one's sense of style. Noncorrective contact lenses that are 
manufactured responsibly and worn under the supervision of a qualified 
eye care professional are useful and a perfectly safe commodity.
  For years, the FDA saw it that way too and properly classified 
colored contact lenses as medical devices. In fact, just over a year 
ago FDA issued an official notification noting that noncorrective 
contacts ``present significant risks of blindness and other eye injury 
if distributed without the involvement of a qualified eye 
professional.''
  But in April, for whatever reason, and we have seen an FDA that has 
become more and more politicized in the last couple of years, but for 
some reason the FDA flip-flopped deciding that colored contact lenses 
were not medical devices and were instead cosmetics. This quiet, but 
important, policy change opened the door to a new public health threat.

[[Page H11566]]

  By reclassifying colored contacts as cosmetics, FDA eliminated the 
requirement that these products be manufactured to exacting standards, 
that they be FDA approved for safety before marketing, and that they be 
labeled with directions for safe use. FDA has expressed concern about 
the safety of noncorrective lenses administered without a doctor's 
involvement. But FDA's decision to reclassify them in this increasingly 
politicized FDA, this decision to reclassify them eliminated its 
authority to require that very involvement.
  Despite concerns raised by Members in the House, but more importantly 
by Prevent Blindness Ohio and other eye health advocates, FDA went 
ahead with this misguided plan. This bill corrects that mistake by 
statutorily reclassifying noncorrective contacts as medical devices by 
statute. This bill was carefully drafted to ensure that this would be 
its only effect, and it clearly states this change will have no 
limiting effect on FDA's discretion in classifying other products under 
the Food, Drug and Cosmetic Act.
  H.R. 2218 enjoys bipartisan support in the Committee on Energy and 
Commerce. The chairman of the Subcommittee on Health, the gentleman 
from Florida (Mr. Bilirakis), and I have cosponsored this legislation, 
as have several other colleagues; and I am joined on the floor today by 
two other leading health advocates, the gentleman from California (Mr. 
Waxman) and the gentlewoman from California (Ms. Eshoo). I urge my 
colleagues to join us in supporting this important legislation in 
protecting the vision and health of American consumers.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to 
the gentleman from Arkansas (Mr. Boozman), who is himself an 
optometrist and certainly has lived with this problem for many, many 
years and knows the real world, and I thank the gentleman for bringing 
this to our attention.
  Mr. BOOZMAN. Mr. Speaker, I thank the gentleman from Florida 
(Chairman Bilirakis) for yielding me this time.
  I also thank the gentleman from California (Mr. Waxman) and his staff 
for working so hard on this bill. They have really gone above and 
beyond the call of duty in spending a great deal of time getting this 
to the situation that we have now. I also thank the gentleman from 
Florida (Mr. Bilirakis) for his help and the gentleman from Louisiana 
(Mr. Tauzin).
  Today we have the opportunity to close a loophole that has caused 
harm to many people young and old throughout the country. The loophole 
is a quirk in the law that allows decorative, plain old contact lenses 
to be sold without a prescription. Although this may not sound like a 
big deal, as a practicing optometrist for over 25 years, it is.
  There are many cases of damage caused by contact lenses sold without 
the supervision of an eye care professional. Take, for instance, the 
case of a 14-year-old girl who purchased a pair of decorative contact 
lenses from a local video store and received no instructions on how to 
care for them. She ended up suffering a severe bacterial eye infection, 
and ultimately had to have a corneal transplant, which is a very 
significant surgery. Or the 32-year-old man who bought a pair of lenses 
at the local flea market for a Halloween costume. Again, the customer 
was provided with no directions at all on proper usage. He was later 
diagnosed with a corneal abrasion. He had scratched his eye because 
they did not fit his eye. He was later in a situation that resulted in 
possible permanent loss of vision.
  Unfortunately, there are many, many more people whose vision has been 
compromised because of this type of contact lens being available to the 
general public without the supervision of eye care professionals. It is 
important to know that although adults are affected by the availability 
of these lenses, our children are the most vulnerable. As all of us who 
have children know, reason is often overruled by the desire to be 
fashionable and trendy.
  Selling lenses to change one's eye color in video stores, flea 
markets, hair salons, and gas stations is inviting trouble and, 
frankly, should not be allowed.
  A simple eye infection is the least of problems with unsupervised 
contact lens use. The worst is it can lead to permanent blindness. 
Proper care of the lenses and instructions on the correct way to use 
them are the keys to preventing these afflictions. Consumers are not 
getting this information from the video store clerk or the gas station 
attendant.
  H.R. 2218 presents a simple fix to a dangerous problem. This bill is 
not intended to address the complicated legal issues surrounding 
intended use. The gentleman from California (Mr. Waxman) and I have 
worked hard to ensure that the language in this bill remains neutral on 
this question, and I think we have succeeded.
  Additionally H.R. 2218 is being endorsed by the health care 
community, including the American Optometric Association and the 
American Academy of Ophthalmology, as well as the leading manufacturers 
in the contact lens industry and consumer protection groups.
  Mr. Speaker, I cannot stress strongly enough that unregulated, 
unsupervised use of decorative contact lenses is extremely hazardous to 
one's health. H.R. 2218 would simply close that loophole that allows 
these lenses to be sold unregulated. I would strongly encourage my 
colleagues to support H.R. 2218.
  Mr. BROWN of Ohio. Mr. Speaker, I yield such time as he may consume 
to the gentleman from California (Mr. Waxman).
  Mr. WAXMAN. Mr. Speaker, I thank the gentleman for yielding me this 
time.
  I am very pleased to be able to join my colleagues in urging support 
for a bill that deems all contact lenses to be medical devices under 
the Federal Food, Drug and Cosmetic Act; and I thank the gentleman from 
Arkansas (Mr. Boozman) for his leadership in sponsoring this 
legislation. Anyone who has any doubts about how significantly contact 
lenses affect the structure and function of the eye need only spend a 
few minutes talking with the gentleman from Arkansas (Mr. Boozman), 
who, by virtue of his professional training, understands these dangers 
better than anyone else in the House of Representatives.
  This bill is urgently needed. All contact lenses pose serious health 
risks. Lenses the wrong size can deprive the surface of the eye of 
oxygen. Lenses worn for too long can cause painful ulcerations of the 
cornea. Lenses that are poorly manufactured or misused can become 
contaminated and cause vision-threatening infections. Until recently, 
FDA had the tools to control the risks of contact lenses. They 
considered all lenses of all types to be Class III medical devices. 
Using its medical device authority, the FDA required that companies 
follow good manufacturing standards, obtain approval prior to 
marketing, report adverse events promptly, and sell their lenses only 
with a prescription from an eye care professional.
  However, under FDA's current interpretation of the law, some contact 
lenses are now considered cosmetic, nonmedical devices. These lenses, 
which the agency refers to as decorative lenses, are colored or feature 
unusual designs. These lenses pose exactly the same health risks as 
other lenses, yet today these lenses only have to comply with 
requirements for cosmetics, and there are very few requirements and 
they are difficult to enforce.
  Treating them in this way, I believe, is a recipe for disaster. 
Lenses sold outside the protections of medical device laws have caused 
numerous eye injuries. It is critically important that FDA have the 
ability to stop these dangerous sales as quickly and efficiently as 
possible. The solution is simple: treat all contact lenses as medical 
devices. No contact lenses should be classified in the same category as 
lipstick.
  H.R. 2218 would ensure that all contact lenses are treated the same 
as medical devices. This bill is enforced by professional associations 
representing ophthalmologists and optometrists, by leading 
manufacturers and by consumer groups. It is a basic consumer 
protection, and it is common sense.
  Finally, let me say this bill has been written with the understanding 
and agreement of all parties that it should not be interpreted as 
either a rejection or a ratification of the legal arguments

[[Page H11567]]

underlying FDA's decision to treat noncorrective lenses as cosmetics. 
For that reason, the bill includes a rule of construction stating that 
the bill should not be construed as having any effect on any product 
regulated by the FDA other than the specific contact lenses at issue 
here. I thank the gentleman from Ohio and the distinguished chairman of 
the Subcommittee on Health, and I join with every Member who has spoken 
on this bill in urging support for it.
  Mr. BILIRAKIS. Mr. Speaker, I have no further requests for time, and 
I yield back the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time, 
and I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Ose). The question is on the motion 
offered by the gentleman from Florida (Mr. Bilirakis) that the House 
suspend the rules and pass the bill, H.R. 2218, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill, as amended, was passed.
  The title of the bill was amended so as to read: ``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.''.
  A motion to reconsider was laid on the table.

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